Colorectal cancer - historical
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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the NCCN Guidelines. Is there a regimen missing from this list? See the main colorectal cancer page for current regimens.
5 regimens on this page
5 variants on this page
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Metastatic disease, first-line
Fluorouracil & Methotrexate (MF)
MF: Methotrexate & Fluorouracil
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Wils et al. 2003 | 1992-1994 | Phase 3 (C) | MF & PALA | Did not meet endpoints of RR/PFS/OS |
Chemotherapy
- Fluorouracil (5-FU) 30 mg/kg/day IV continuous infusion over 48 hours, started on day 1 (total dose per cycle: 60 mg/kg)
- Methotrexate (MTX) 40 mg/m2 IV once on day 1, given first
7-day cycle for 3 cycles, then 14-day cycles
References
- Wils J, Blijham GH, Wagener T, De Greve J, Jansen RL, Kok TC, Nortier JW, Bleiberg H, Couvreur ML, Genicot B, Baron B; EORTC Gastrointestinal Group. High-dose 5-fluorouracil plus low dose methotrexate plus or minus low-dose PALA in advanced colorectal cancer: a randomised phase II-III trial of the EORTC Gastrointestinal Group. Eur J Cancer. 2003 Feb;39(3):346-52. link to original article contains dosing details in manuscript PubMed
Fluorouracil & Mitomycin
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Price et al. 2004 | 1996-1998 | Phase 3 (C) | Fluorouracil & Mitomycin; chronomodulated | Did not meet endpoints of FFS/OS |
Chemotherapy
- Fluorouracil (5-FU) 300 mg/m2/day IV continuous infusion over 42 days, started on day 1 (total dose per cycle: 12,600 mg/m2)
- Mitomycin (Mutamycin) 7 mg/m2 (maximum dose of 14 mg) IV once on day 1
42-day cycle for up to 4 cycles
References
- Price TJ, Ross PJ, Hickish T, Tait D, Norman AR, Ford HE, Middleton G, Sumpter K, Hill M, Oates J, Cunningham D. Phase III study of mitomycin-C with protracted venous infusion or circadian-timed infusion of 5-fluorouracil in advanced colorectal carcinoma. Clin Colorectal Cancer. 2004 Feb;3(4):235-42. link to original article contains dosing details in manuscript PubMed
Fluorouracil & Semustine
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Baker et al. 1976 | 1973-03 to 1974-10 | Phase 3 (C) | 5-FU | Superior ORR |
| Engstrom et al. 1982 (ECOG E4275) | NR | Phase 3 (E-switch-ic) | 1. 5-FU, Semustine, Vincristine 2. 5-FU, Dacarbazine, Semustine 3. 5-FU, Dacarbazine, Semustine, Vincristine 4. 5-FU & Hydrea |
Did not meet endpoints of RR/OS |
Chemotherapy
- Fluorouracil (5-FU) 400 mg/m2 IV once per day on days 1, 8, 15, 22, 29, 36
- Semustine (MeCCNU) 175 mg/m2 PO once on day 1
42-day cycles
References
- Baker LH, Talley RW, Matter R, Lehane DE, Ruffner BW, Jones SE, Morrison FS, Stephens RL, Gehan EA, Vaitkevicius VK; Southwest Oncology Group. Phase III comparison of the treatment of advanced gastrointestinal cancer with bolus weekly 5-FU vs methyl-CCNU plus bolus weekly 5-FU: a Southwest Oncology Group study. Cancer. 1976 Jul;38(1):1-7. link to original article contains dosing details in abstract PubMed
- ECOG E4275: Engstrom PF, MacIntyre JM, Douglass HO Jr, Muggia F, Mittelman A. Combination chemotherapy of advanced colorectal cancer utilizing 5-fluorouracil, semustine, dacarbazine, vincristine, and hydroxyurea: a phase III trial by the Eastern Cooperative Oncology Group (EST: 4275). Cancer. 1982 Apr 15;49(8):1555-60. link to original article PubMed
FOLFOX chronotherapy
FOLFOX: FOLinic acid (Leucovorin), Fluorouracil, OXaliplatin
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Lévi et al. 1997 | 1991-1993 | Phase 3 (E-switch-ic) | FOLFOX; CI | Superior TTF |
Note: This schedule is "chronomodulated"; see paper for details.
Chemotherapy
- Leucovorin (Folinic acid) 300 mg/m2 IV over 12 hours once per day on days 1 to 5, given second, with 5-FU
- Fluorouracil (5-FU) 600 mg/m2 IV over 12 hours once per day on days 1 to 5, given second, with leucovorin
- Oxaliplatin (Eloxatin) 20 mg/m2 IV over 12 hours once per day on days 1 to 5, given first
21-day cycles
References
- Lévi F, Zidani R, Misset JL; International Organization for Cancer Chronotherapy. Randomised multicentre trial of chronotherapy with oxaliplatin, fluorouracil, and folinic acid in metastatic colorectal cancer. Lancet. 1997 Sep 6;350(9079):681-6. link to original article contains dosing details in manuscript PubMed
Raltitrexed monotherapy
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Cunningham et al. 1995 | 1993-11 to 1994-06 | Phase 3 (E-switch-ooc) | FULV; Mayo Clinic regimen (LDLV) | Did not meet primary endpoint of TTP |
| Cocconi et al. 1998 | 1995-07 to 1996-02 | Phase 3 (E-switch-ooc) | FULV; HDLV | Inferior TTP |
References
- Cunningham D, Zalcberg JR, Rath U, Olver I, Van Cutsem E, Svensson C, Seitz JF, Harper P, Kerr D, Perez-Manga G, Azab M, Seymour L, Lowery K; The 'Tomudex' Colorectal Cancer Study Group. 'Tomudex' (ZD1694): results of a randomised trial in advanced colorectal cancer demonstrate efficacy and reduced mucositis and leucopenia. Eur J Cancer. 1995 Nov;31A(12):1945-54. link to original article contains dosing details in manuscript PubMed
- Update: Cunningham D, Zalcberg JR, Rath U, Oliver I, van Cutsem E, Svensson C, Seitz JF, Harper P, Kerr D, Perez-Manga G; "Tomudex" Colorectal Cancer Study Group. Final results of a randomised trial comparing 'Tomudex' (raltitrexed) with 5-fluorouracil plus leucovorin in advanced colorectal cancer. Ann Oncol. 1996 Nov;7(9):961-5. Erratum in: Ann Oncol 1997 Apr;8(4):407. link to original article PubMed
- Cocconi G, Cunningham D, Van Cutsem E, Francois E, Gustavsson B, van Hazel G, Kerr D, Possinger K, Hietschold SM; Tomudex Colorectal Cancer Study Group. Open, randomized, multicenter trial of raltitrexed versus fluorouracil plus high-dose leucovorin in patients with advanced colorectal cancer. J Clin Oncol. 1998 Sep;16(9):2943-52. link to original article contains dosing details in manuscript PubMed
- MRC CR06: Maughan TS, James RD, Kerr DJ, Ledermann JA, McArdle C, Seymour MT, Cohen D, Hopwood P, Johnston C, Stephens RJ; British MRC Colorectal Cancer Working Party. Comparison of survival, palliation, and quality of life with three chemotherapy regimens in metastatic colorectal cancer: a multicentre randomised trial. Lancet. 2002 May 4;359(9317):1555-63. link to original article PubMed NCT00002893
- FFCD 9601: Ducreux M, Bouche O, Pignon JP, Mousseau M, Raoul JL, Cassan P, Leduc B, Berger C, Dunant A, Fournet J, Bedenne L; FFCD. Randomised trial comparing three different schedules of infusional 5FU and raltitrexed alone as first-line therapy in metastatic colorectal cancer: final results of the Fédération Francophone de Cancérologie Digestive (FFCD) 9601 trial. Oncology. 2006;70(3):222-30. Epub 2006 Jun 30. link to original article PubMed