Endometrial cancer

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35 regimens on this page 55 variants on this page

Endocrine therapy for endometrioid histologies

Anastrozole (Arimidex)

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Regimen

Study	Evidence
Rose et al. 2000	Phase II

Endocrine therapy

• Anastrozole (Arimidex) 1 mg PO once per day

given until progression of disease or unacceptable toxicity

References

1. Rose PG, Brunetto VL, VanLe L, Bell J, Walker JL, Lee RB. A phase II trial of anastrozole in advanced recurrent or persistent endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2000 Aug;78(2):212-6. link to original article contains verified protocol PubMed

Medroxyprogesterone acetate (MPA)

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Regimen

Study	Evidence	Comparator
Thigpen et al. 1999	Phase III	High-dose medroxyprogesterone acetate

Endocrine therapy

• Medroxyprogesterone acetate (MPA) 200 mg PO once per day

Given until progression of disease or unacceptable toxicity

References

1. Thigpen JT, Brady MF, Alvarez RD, Adelson MD, Homesley HD, Manetta A, Soper JT, Given FT. Oral medroxyprogesterone acetate in the treatment of advanced or recurrent endometrial carcinoma: a dose-response study by the Gynecologic Oncology Group. J Clin Oncol. 1999 Jun;17(6):1736-44. link to original article contains verified protocol PubMed

Medroxyprogesterone acetate & Tamoxifen

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Regimen

Study	Evidence
Whitney et al. 2004	Phase II

Endocrine therapy

• Medroxyprogesterone acetate (MPA) 100 mg PO BID on even-numbered weeks (for example, week 2, 4, 6, etc.)
• Tamoxifen (Nolvadex) 20 mg PO BID

Given until progression of disease or unacceptable toxicity

References

1. Whitney CW, Brunetto VL, Zaino RJ, Lentz SS, Sorosky J, Armstrong DK, Lee RB; Gynecologic Oncology Group study. Phase II study of medroxyprogesterone acetate plus tamoxifen in advanced endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2004 Jan;92(1):4-9. link to original article contains verified protocol PubMed

Megestrol acetate (Megace)

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Regimen

Study	Evidence	Comparator
Pandya et al. 2001 (E4882)	Randomized Phase II	Megestrol acetate & Tamoxifen

Endocrine therapy

• Megestrol acetate (Megace) 80 mg PO BID

Given until progression of disease or unacceptable toxicity

References

1. Pandya KJ, Yeap BY, Weiner LM, Krook JE, Erban JK, Schinella RA, Davis TE. Megestrol and tamoxifen in patients with advanced endometrial cancer: an Eastern Cooperative Oncology Group Study (E4882). Am J Clin Oncol. 2001 Feb;24(1):43-6. link to original article contains verified protocol PubMed

Megestrol acetate & Tamoxifen

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Regimen

Study	Evidence	Comparator
Pandya et al. 2001 (E4882)	Randomized Phase II	Megestrol acetate

Endocrine therapy

• Megestrol acetate (Megace) 80 mg PO BID x 3 weeks, alternating with tamoxifen
• Tamoxifen (Nolvadex) 20 mg PO BID x 3 weeks, alternating with megestrol

3-week courses of Megestrol acetate (Megace), alternating back and forth with 3-week courses of Tamoxifen (Nolvadex); given until progression of disease or unacceptable toxicity

References

1. Pandya KJ, Yeap BY, Weiner LM, Krook JE, Erban JK, Schinella RA, Davis TE. Megestrol and tamoxifen in patients with advanced endometrial cancer: an Eastern Cooperative Oncology Group Study (E4882). Am J Clin Oncol. 2001 Feb;24(1):43-6. link to original article contains verified protocol PubMed
2. Fiorica JV, Brunetto VL, Hanjani P, Lentz SS, Mannel R, Andersen W; Gynecologic Oncology Group study. Phase II trial of alternating courses of megestrol acetate and tamoxifen in advanced endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2004 Jan;92(1):10-4. link to original article contains verified protocol PubMed

Tamoxifen (Nolvadex)

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Regimen

Study	Evidence
Quinn et al. 1989	Phase II
Thigpen et al. 2001	Phase II

Endocrine therapy

• Tamoxifen (Nolvadex) 20 mg PO BID

Given until progression of disease or unacceptable toxicity

References

1. Quinn MA, Campbell JJ. Tamoxifen therapy in advanced/recurrent endometrial carcinoma. Gynecol Oncol. 1989 Jan;32(1):1-3. link to SD article PubMed
2. Thigpen T, Brady MF, Homesley HD, Soper JT, Bell J. Tamoxifen in the treatment of advanced or recurrent endometrial carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2001 Jan 15;19(2):364-7. link to original article contains verified protocol PubMed

Adjuvant radiation & chemotherapy

RT -> Cisplatin & Doxorubicin

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RT: Radiation Therapy

Regimen

Study	Evidence	Comparator
Homesley et al. 2008 (GOG 184)	Phase III	Cisplatin, Doxorubicin, Paclitaxel, RT

Note: for chemotherapy, body surface area capped at 2.0 m². Radiation is to begin within 8 weeks after surgery.

Radiotherapy

• Radiation therapy to the pelvis, 1.8 Gy x 28 fractions (total dose: 50.4 Gy)
  • Patients with positive para-aortic lymph nodes received 1.5 to 1.8 Gy x 24 to 29 fractions (total dose: 43.5 Gy)

6-week course, followed within 8 weeks by:

Chemotherapy

• Cisplatin (Platinol) 50 mg/m² IV once on day 1, given second
• Doxorubicin (Adriamycin) 45 mg/m² IV once on day 1, given first

Supportive medications

• G-CSF, either of the following:
  • Filgrastim (Neupogen) 5 mcg/kg SC once per day on days 2 to 11, or until ANC increases to 10,000
  • Pegfilgrastim (Neulasta) 6 mg SC once on day 2
• Dexamethasone (Decadron) 10 mg IV once prior to chemotherapy
• 5-HT3 antagonist

21-day cycle for 6 cycles

References

1. Homesley HD, Filiaci V, Gibbons SK, Long HJ, Cella D, Spirtos NM, Morris RT, DeGeest K, Lee R, Montag A. A randomized phase III trial in advanced endometrial carcinoma of surgery and volume directed radiation followed by cisplatin and doxorubicin with or without paclitaxel: A Gynecologic Oncology Group study. Gynecol Oncol. 2009 Mar;112(3):543-52. Epub 2008 Dec 23. link to original article link to PMC article contains verified protocol PubMed

RT -> Cisplatin, Doxorubicin, Paclitaxel

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RT: Radiation Therapy

Regimen

Study	Evidence	Comparator
Homesley et al. 2008 (GOG 184)	Phase III	Cisplatin, Doxorubicin, RT

Note: for chemotherapy, body surface area capped at 2.0 m². Radiation is to start within 8 weeks after surgery.

Radiotherapy

• Radiation therapy to the pelvis, 1.8 Gy x 28 fractions (total dose: 50.4 Gy)
  • Patients with positive para-aortic lymph nodes received 1.5 to 1.8 Gy x 24 to 29 fractions (total dose: 43.5 Gy)

6-week course, followed within 8 weeks by:

Chemotherapy

• Cisplatin (Platinol) 50 mg/m² IV once on day 1, given second
• Doxorubicin (Adriamycin) 45 mg/m² IV once on day 1, given first
• Paclitaxel (Taxol) 160 mg/m² IV over 3 hours once on day 2

Supportive medications

• Filgrastim (Neupogen) 5 mcg/kg SC once per day on days 3 to 12, or until ANC increases to 10,000
• Dexamethasone (Decadron) 10 mg IV once prior to day 1 chemotherapy; Dexamethasone (Decadron) 20 mg once 5 to 12 hours prior to paclitaxel on day 2
• 5-HT3 antagonist

21-day cycle for 6 cycles

References

1. Homesley HD, Filiaci V, Gibbons SK, Long HJ, Cella D, Spirtos NM, Morris RT, DeGeest K, Lee R, Montag A. A randomized phase III trial in advanced endometrial carcinoma of surgery and volume directed radiation followed by cisplatin and doxorubicin with or without paclitaxel: A Gynecologic Oncology Group study. Gynecol Oncol. 2009 Mar;112(3):543-52. Epub 2008 Dec 23. link to original article link to PMC article contains verified protocol PubMed

Advanced, recurrent, or metastatic disease

Bevacizumab (Avastin)

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Regimen

Study	Evidence
Aghajanian et al. 2011	Phase II

Chemotherapy

• Bevacizumab (Avastin) 15 mg/kg IV once on day 1

21-day cycles, given until progression of disease or unacceptable toxicity

References

1. Aghajanian C, Sill MW, Darcy KM, Greer B, McMeekin DS, Rose PG, Rotmensch J, Barnes MN, Hanjani P, Leslie KK. Phase II trial of bevacizumab in recurrent or persistent endometrial cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2011 Jun 1;29(16):2259-65. Epub 2011 May 2. link to original article contains verified protocol PubMed

Carboplatin (Paraplatin)

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Regimen

Study	Evidence
van Wijk et al. 2003	Phase II

Chemotherapy

• Carboplatin (Paraplatin) 400 mg/m² IV over 30 minutes once on day 1
  • Dosage for patients with previously treated with chemotherapy is Carboplatin (Paraplatin) 300 mg/m² IV over 30 minutes once on day 1

28-day cycles

References

1. van Wijk FH, Lhommé C, Bolis G, Scotto di Palumbo V, Tumolo S, Nooij M, de Oliveira CF, Vermorken JB; European Organization for Research and Treatment of Cancer. Gynaecological Cancer Group. Phase II study of carboplatin in patients with advanced or recurrent endometrial carcinoma. A trial of the EORTC Gynaecological Cancer Group. Eur J Cancer. 2003 Jan;39(1):78-85. link to original article contains verified protocol PubMed

Carboplatin & Doxorubicin liposomal

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Regimen

Study	Evidence
Pignata et al. 2007 (END-1)	Phase II

Chemotherapy

• Carboplatin (Paraplatin) AUC 5 IV over 30 minutes once on day 1, given first
• Doxorubicin liposomal (Doxil) 40 mg/m² IV over 60 minutes once on day 1, given second

Supportive medications

• "No prophylactic use of G-CSF was recommended. In case of grade 4 neutropaenia, even without fever, therapeutic and prophylactic use of G-CSF was allowed."

28-day cycle for 3 to 6 cycles

All patients received 3 cycles of therapy. If there was no unacceptable toxicity, patients with stable or responsive disease received an additional 3 cycles.

References

1. Pignata S, Scambia G, Pisano C, Breda E, Di Maio M, Greggi S, Ferrandina G, Lorusso D, Zagonel V, Febbraro A, Riva N, De Rosa V, Gallo C, Perrone F; Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies Group. A multicentre phase II study of carboplatin plus pegylated liposomal doxorubicin as first-line chemotherapy for patients with advanced or recurrent endometrial carcinoma: the END-1 study of the MITO (Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies) group. Br J Cancer. 2007 Jun 4;96(11):1639-43. Epub 2007 May 8. link to PMC article contains verified protocol PubMed

Carboplatin & Paclitaxel

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Regimen #1

Study	Evidence
Pectasides et al. 2008	Phase II

Chemotherapy

• Carboplatin (Paraplatin) AUC 5 IV over 1 hour once on day 1, given second
• Paclitaxel (Taxol) 175 mg/m² IV over 3 hours once on day 1, given first

21-day cycle for 6 to 9 cycles

Regimen #2

Study	Evidence
Hoskins et al. 2001	Phase II

Chemotherapy

• Carboplatin (Paraplatin) AUC 5 to 7 IV once on day 1, given second
• Paclitaxel (Taxol) 175 mg/m² IV over 3 hours once on day 1, given first

21-day cycles

Regimen #3

Study	Evidence
Sorbe et al. 2008	Phase II

Chemotherapy

• Carboplatin (Paraplatin) AUC 5 IV over 1 hour once on day 1
• Paclitaxel (Taxol) 175 mg/m² IV over 3 hours once on day 1

21-day cycles

References

1. Hoskins PJ, Swenerton KD, Pike JA, Wong F, Lim P, Acquino-Parsons C, Lee N. Paclitaxel and carboplatin, alone or with irradiation, in advanced or recurrent endometrial cancer: a phase II study. J Clin Oncol. 2001 Oct 15;19(20):4048-53. link to original article contains verified protocol PubMed
2. Pectasides D, Xiros N, Papaxoinis G, Pectasides E, Sykiotis C, Koumarianou A, Psyrri A, Gaglia A, Kassanos D, Gouveris P, Panayiotidis J, Fountzilas G, Economopoulos T. Carboplatin and paclitaxel in advanced or metastatic endometrial cancer. Gynecol Oncol. 2008 May;109(2):250-4. Epub 2008 Mar 4. link to original article contains verified protocol PubMed content property of HemOnc.org
3. Sorbe B, Andersson H, Boman K, Rosenberg P, Kalling M. Treatment of primary advanced and recurrent endometrial carcinoma with a combination of carboplatin and paclitaxel-long-term follow-up. Int J Gynecol Cancer. 2008 Jul-Aug;18(4):803-8. Epub 2007 Oct 18. link to original article contains verified protocol PubMed
4. Retrospective: Shechter-Maor G, Bruchim I, Ben-Harim Z, Altaras M, Fishman A. Combined chemotherapy regimen of carboplatin and paclitaxel as adjuvant treatment for papillary serous and clear cell endometrial cancer. Int J Gynecol Cancer. 2009 May;19(4):662-4. link to original article PubMed

Cisplatin & Doxorubicin

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Regimen #1

Study	Evidence	Comparator
Fleming et al. 2004 (GOG 177)	Phase III	Cisplatin, Doxorubicin, Paclitaxel

Note: body surface area capped at 2.0 m².

Chemotherapy

• Cisplatin (Platinol) 50 mg/m² IV over 1 hour once on day 1, given second
• Doxorubicin (Adriamycin) 60 mg/m² IV once on day 1, given first
  • Dosage for patients with previous pelvic radiation or who were >65 years old is Doxorubicin (Adriamycin) 45 mg/m² IV once on day 1

21-day cycle for 7 cycles

Regimen #2

Study	Evidence	Comparator
Randall et al. 2006 (GOG 122)	Phase III	Whole abdominal irradiation

Chemotherapy

• Cisplatin (Platinol) 50 mg/m² IV once on day 1 of cycles 1 to 8
• Doxorubicin (Adriamycin) 60 mg/m² IV once on day 1 of cycles 1 to 7

Supportive hydration:

• Normal saline at 500 mL/H for 2 hours prior to and after cisplatin

21-day cycle for 8 cycles

References

1. Fleming GF, Brunetto VL, Cella D, Look KY, Reid GC, Munkarah AR, Kline R, Burger RA, Goodman A, Burks RT. Phase III trial of doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2004 Jun 1;22(11):2159-66. link to original article contains verified protocol PubMed
2. Randall ME, Filiaci VL, Muss H, Spirtos NM, Mannel RS, Fowler J, Thigpen JT, Benda JA; Gynecologic Oncology Group Study. Randomized phase III trial of whole-abdominal irradiation versus doxorubicin and cisplatin chemotherapy in advanced endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2006 Jan 1;24(1):36-44. Epub 2005 Dec 5. link to original article contains verified protocol PubMed

Cisplatin, Doxorubicin, Paclitaxel

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Regimen

Study	Evidence	Comparator
Fleming et al. 2004 (GOG 177)	Phase III	Cisplatin & Doxorubicin

Note: body surface area capped at 2.0 m².

Chemotherapy

• Cisplatin (Platinol) 50 mg/m² IV over 1 hour once on day 1, given second
• Doxorubicin (Adriamycin) 45 mg/m² IV once on day 1, given first
• Paclitaxel (Taxol) 160 mg/m² IV over 3 hours once on day 2

Supportive medications

• Filgrastim (Neupogen) 5 mcg/kg SC once per day on days 3 to 12

21-day cycle for 7 cycles

References

1. Fleming GF, Brunetto VL, Cella D, Look KY, Reid GC, Munkarah AR, Kline R, Burger RA, Goodman A, Burks RT. Phase III trial of doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2004 Jun 1;22(11):2159-66. link to original article contains verified protocol PubMed

Cisplatin, Ifosfamide, Mesna (CIM)

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CIM: Cisplatin, Ifosfamide, Mesna

Regimen

Study	Evidence	Comparator
Wolfson et al. 2007 (GOG 150)	Phase III	Whole abdominal irradiation

Chemotherapy

• Cisplatin (Platinol) 20 mg/m² IV at an infusion rate of approximately 1 mg/min once per day on days 1 to 4, given first
• Ifosfamide (Ifex) 1500 mg/m² IV over 1 hour once per day on days 1 to 4, given second together with Mesna (Mesnex)

Supportive medications

• Mesna (Mesnex) 120 mg/m² IV bolus over 15 minutes once on day 1, then 1500 mg/m²/day IV continuous infusion over 96 hours on days 1 to 4, given second together with Ifosfamide (Ifex)
• Suggested hydration: 1 liter of NS or 1/2 NS given over several hours prior to chemotherapy

21-day cycle for 3 cycles

References

1. Wolfson AH, Brady MF, Rocereto T, Mannel RS, Lee YC, Futoran RJ, Cohn DE, Ioffe OB. A gynecologic oncology group randomized phase III trial of whole abdominal irradiation (WAI) vs. cisplatin-ifosfamide and mesna (CIM) as post-surgical therapy in stage I-IV carcinosarcoma (CS) of the uterus. Gynecol Oncol. 2007 Nov;107(2):177-85. Epub 2007 Sep 5. link to PMC article contains verified protocol PubMed

Cisplatin & Paclitaxel

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Regimen

Study	Evidence
Dimopoulos et al. 2000	Phase II

Chemotherapy

• Cisplatin (Platinol) 75 mg/m² IV over 2 hours once on day 1, given second
• Paclitaxel (Taxol) 175 mg/m² IV over 3 hours once on day 1, given first

Supportive medications

• Dexamethasone (Decadron) 20 mg PO/IV given twice, 12 and 6 hours prior to Paclitaxel (Taxol)
• Diphenhydramine (Benadryl) 25 mg IV once 30 minutes prior to Paclitaxel (Taxol)
• Ranitidine (Zantac) 50 mg IV once 30 minutes prior to Paclitaxel (Taxol)
• 900 mL normal saline mixed with 100 mL mannitol given over 1 hour prior to Cisplatin (Platinol)
• 2 liters NS with potassium & magnesium after Cisplatin (Platinol)
• "Appropriate antiemetics"
• Filgrastim (Neupogen) 5 mcg/kg SC once per day, starting on day 5 and continuing until WBC >10,000

21-day cycle for up to 6 cycles

References

1. Dimopoulos MA, Papadimitriou CA, Georgoulias V, Moulopoulos LA, Aravantinos G, Gika D, Karpathios S, Stamatelopoulos S. Paclitaxel and cisplatin in advanced or recurrent carcinoma of the endometrium: long-term results of a phase II multicenter study. Gynecol Oncol. 2000 Jul;78(1):52-7. link to original article contains verified protocol PubMed

Dactinomycin (Cosmegen)

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Regimen

Study	Evidence
Moore et al. 1999	Phase II

Chemotherapy

• Dactinomycin (Cosmegen) 2 mg/m² IV over 15 minutes once on day 1

28-day cycles

References

1. Moore DH, Blessing JA, Dunton C, Buller RE, Reid GC. Dactinomycin in the treatment of recurrent or persistent endometrial carcinoma: A Phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 1999 Dec;75(3):473-5. link to original article contains verified protocol PubMed

Ifosfamide

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Regimen

Study	Evidence	Comparator
Homesley et al. 2007 (GOG 161)	Phase III	Ifosfamide & Paclitaxel

Note: GOG 161 specifies that PO Mesna (Mesnex) is to be taken in 3 divided doses, but only lists 2 time points for its use. The timing of the middle dose is estimated based on other references.

Chemotherapy

• Ifosfamide (Ifex) 1600 mg/m² IV once per day on days 1 to 3
  • Dosage for patients with previous radiation is Ifosfamide (Ifex) 1200 mg/m² IV once per day on days 1 to 3

Supportive medications

• Mesna (Mesnex) 2000 mg IV over 12 hours once per day on days 1 to 3, starting 15 minutes before Ifosfamide (Ifex)
  • Alternate PO dosing: Mesna (Mesnex) 1330 mg PO taken three times per day, 1 hour before, 4 hours after, and 8 hours after Ifosfamide (Ifex) (4000 mg total dose per day), on days 1 to 3
• Filgrastim (Neupogen) 5 mcg/kg SC once per day starting on day 4, to continue until ANC is greater than or equal to 2000

21-day cycle for 8 cycles

References

1. Homesley HD, Filiaci V, Markman M, Bitterman P, Eaton L, Kilgore LC, Monk BJ, Ueland FR; Gynecologic Oncology Group. Phase III trial of ifosfamide with or without paclitaxel in advanced uterine carcinosarcoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Feb 10;25(5):526-31. link to original article contains verified protocol PubMed

Ifosfamide & Paclitaxel

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Regimen

Study	Evidence	Comparator
Homesley et al. 2007 (GOG 161)	Phase III	Ifosfamide

Note: GOG 161 specifies that PO Mesna (Mesnex) is to be taken in 3 divided doses, but only lists 2 time points for its use. The timing of the middle dose is estimated based on other references.

Chemotherapy

• Ifosfamide (Ifex) 1600 mg/m² IV once per day on days 1 to 3
  • Dosage for patients with previous radiation is Ifosfamide (Ifex) 1200 mg/m² IV once per day on days 1 to 3
• Paclitaxel (Taxol) 135 mg/m² IV over 3 hours once on day 1

Supportive medications

• Mesna (Mesnex) 2000 mg IV over 12 hours once per day on days 1 to 3, starting 15 minutes before Ifosfamide (Ifex)
  • Alternate PO dosing: Mesna (Mesnex) 1330 mg PO taken three times per day, 1 hour before, 4 hours after, and 8 hours after Ifosfamide (Ifex) (4000 mg total dose per day), on days 1 to 3
• Filgrastim (Neupogen) 5 mcg/kg SC once per day starting on day 4, to continue until ANC is greater than or equal to 2000
• Dexamethasone (Decadron) 20 mg PO/IV given twice, 12 and 6 hours prior to Paclitaxel (Taxol)
• Diphenhydramine (Benadryl) 50 mg IV once 30 minutes prior to Paclitaxel (Taxol)
• Cimetidine (Tagamet) 300 mg IV or Ranitidine (Zantac) 50 mg IV once 30 minutes prior to Paclitaxel (Taxol)

21-day cycle for 8 cycles

References

1. Homesley HD, Filiaci V, Markman M, Bitterman P, Eaton L, Kilgore LC, Monk BJ, Ueland FR; Gynecologic Oncology Group. Phase III trial of ifosfamide with or without paclitaxel in advanced uterine carcinosarcoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Feb 10;25(5):526-31. link to original article contains verified protocol PubMed

Paclitaxel (Taxol)

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Regimen #1

Study	Evidence
Lincoln et al. 2003	Phase II

Chemotherapy

• Paclitaxel (Taxol) 200 mg/m² IV over 3 hours once on day 1
  • Dosage for patients with previous pelvic radiation is Paclitaxel (Taxol) 175 mg/m² IV over 3 hours once on day 1
  • Dose of Paclitaxel (Taxol) can be changed to 135 or 110 mg/m² depending on toxicity

Supportive medications

• Dexamethasone (Decadron) 20 mg PO/IV given twice, 12 and 6 hours prior to paclitaxel
• Diphenhydramine (Benadryl) 50 mg PO/IV once 30 minutes prior to paclitaxel
• Cimetidine (Tagamet) 300 mg IV once 30 minutes prior to paclitaxel

21-day cycles

Regimen #2

Study	Evidence
Lissoni et al. 1996	Phase II

Chemotherapy

• Paclitaxel (Taxol) 175 mg/m² IV over 3 hours once on day 1

Supportive medications

• Hydrocortisone (Cortef) 250 mg IV once 1 hour prior to paclitaxel
• Chlorphenamine/chlorpheniramine (H1 blocker) 10 mg IM once 1 hour prior to paclitaxel
• Cimetidine (Tagamet) 300 mg IV once 1 hour prior to paclitaxel

21-day cycles

Regimen #3

Study	Evidence
Ball et al. 1996	Phase II

Chemotherapy

• Paclitaxel (Taxol) 250 mg/m² IV continuous infusion over 24 hours once on day 1
  • Dosage for patients with previous pelvic radiation is 200 mg/m² IV continuous infusion over 24 hours once on day 1
  • Dose can be changed to 200, 170, 135, 110 mg/m² depending on toxicity

Supportive medications

• Dexamethasone (Decadron) 20 mg PO/IV given twice, 12 and 6 hours prior to paclitaxel
• Diphenhydramine (Benadryl) 50 mg PO/IV once 30 minutes prior to paclitaxel
• Cimetidine (Tagamet) 300 mg IV once 30 minutes prior to paclitaxel
• Filgrastim (Neupogen) 5 mcg/kg SC once per day starting on day 3, 24 hours after chemotherapy, continued for at least 12 days or until two successive total leukocyte counts are 10,000 or greater, whichever comes last

21-day cycles

References

1. Ball HG, Blessing JA, Lentz SS, Mutch DG. A phase II trial of paclitaxel in patients with advanced or recurrent adenocarcinoma of the endometrium: a Gynecologic Oncology Group study. Gynecol Oncol. 1996 Aug;62(2):278-81. link to original article contains verified protocol PubMed
2. Lissoni A, Zanetta G, Losa G, Gabriele A, Parma G, Mangioni C. Phase II study of paclitaxel as salvage treatment in advanced endometrial cancer. Ann Oncol. 1996 Oct;7(8):861-3. link to original article contains verified protocol PubMed
3. Lincoln S, Blessing JA, Lee RB, Rocereto TF. Activity of paclitaxel as second-line chemotherapy in endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2003 Mar;88(3):277-81. link to original article contains verified protocol PubMed

Temsirolimus (Torisel)

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Regimen

Study	Evidence
Oza et al. 2011	Phase II

Chemotherapy

• Temsirolimus (Torisel) 25 mg IV over 30 minutes once per day on days 1, 8, 15, 22

28-day cycles, given until progression of disease, unacceptable toxicity, or patient decision

References

1. Oza AM, Elit L, Tsao MS, Kamel-Reid S, Biagi J, Provencher DM, Gotlieb WH, Hoskins PJ, Ghatage P, Tonkin KS, Mackay HJ, Mazurka J, Sederias J, Ivy P, Dancey JE, Eisenhauer EA. Phase II study of temsirolimus in women with recurrent or metastatic endometrial cancer: a trial of the NCIC Clinical Trials Group. J Clin Oncol. 2011 Aug 20;29(24):3278-85. Epub 2011 Jul 25. link to original article contains verified protocol PubMed

Topotecan (Hycamtin)

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Regimen

Study	Evidence
Wadler et al. 2003 (ECOG E3E93)	Phase II

Chemotherapy

• Topotecan (Hycamtin) 1.5 mg/m² IV once per day on days 1 to 5
  • Dosage for patients with previous pelvic radiation is 1.2 mg/m², which can be increased to the 1.5 mg/m² dose in later cycles if there are no toxicities higher than grade 1

21-day cycles

References

1. Wadler S, Levy DE, Lincoln ST, Soori GS, Schink JC, Goldberg G. Topotecan is an active agent in the first-line treatment of metastatic or recurrent endometrial carcinoma: Eastern Cooperative Oncology Group Study E3E93. J Clin Oncol. 2003 Jun 1;21(11):2110-4. link to original article contains verified protocol PubMed

Whole abdominal radiation (WAI)

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Regimen

Study	Evidence	Comparator
Randall et al. 2006 (GOG 122)	Phase III	Cisplatin & Doxorubicin
Wolfson et al. 2007 (GOG 150)	Phase III	CIM

Not commonly used but was a comparator arm; here for reference purposes only.

References

1. Randall ME, Filiaci VL, Muss H, Spirtos NM, Mannel RS, Fowler J, Thigpen JT, Benda JA; Gynecologic Oncology Group Study. Randomized phase III trial of whole-abdominal irradiation versus doxorubicin and cisplatin chemotherapy in advanced endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2006 Jan 1;24(1):36-44. Epub 2005 Dec 5. link to original article contains verified protocol PubMed
2. Wolfson AH, Brady MF, Rocereto T, Mannel RS, Lee YC, Futoran RJ, Cohn DE, Ioffe OB. A gynecologic oncology group randomized phase III trial of whole abdominal irradiation (WAI) vs. cisplatin-ifosfamide and mesna (CIM) as post-surgical therapy in stage I-IV carcinosarcoma (CS) of the uterus. Gynecol Oncol. 2007 Nov;107(2):177-85. Epub 2007 Sep 5. link to PMC article contains verified protocol PubMed