Randomized phase III Study of 5‐fluorouracil plus high dose folinic acid versus 5‐fluorouracil plus folinic acid plus methyl‐lomustine for patients with advanced colorectal cancer

Background. Metastatic colorectal cancer is generally incurable. The most active regimen available, 5‐fluorouracil (5‐FU) and folinic acid (Leucovorin), produces response rates of approximately 25% to 30%. Methyl‐lomustine is a nitrosourea with modest activity against colorectal cancer. A randomized trial was undertaken to evaluate the impact the addition of methyl‐lomustine would have on response, duration of survival, and survival rates in patients with advanced colorectal cancer.

[1]  T. Tong,et al.  Cancer statistics, 1991 , 1991, CA: a cancer journal for clinicians.

[2]  B. Levin,et al.  Phase I trial of semustine plus weekly fluorouracil and high-dose leucovorin calcium in patients with advanced colorectal cancer. , 1989, Journal of the National Cancer Institute.

[3]  P. Engstrom,et al.  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) , 1982, Cancer.

[4]  B. Hoogstraten,et al.  5 FU infusion with mitomycin‐C vs. 5 FU infusion with methyl‐CCNU in the treatment of advanced upper gastrointestinal cancer. A Southwest oncology group study , 1979, Cancer.

[5]  V. Vaitkevicius,et al.  Phase ii evaluation of ftorafur in previously untreated colorectal cancer: A southwest oncology group study , 1979, Cancer.

[6]  N. Kemeny,et al.  A randomized study of two different schedules of methyl CCNU, 5‐FU and vincristine for metastatic colorectal carcinoma , 1979, Cancer.

[7]  P. Lavin,et al.  Chemotherapy of advanced measurable colon and rectal carcinoma with oral 5‐fluorouracil, alone or in combination with cyclophosphamide or 6‐thioguanine, with intravenous 5‐fluorouracil or beta‐2′‐deoxythioguanosine or with oral 3(4‐methyl‐cyclohexyl)‐1(2‐chlorethyl)‐1‐nitrosourea. A phase II‐III stu , 1978, Cancer.

[8]  R. Berman,et al.  Randomized trial of melphalan plus 5-fluorouracil (5-FU) versus methyl-CCNU plus 5-FU in patients with advanced colorectal cancer. , 1978, Cancer treatment reports.

[9]  R. Mayer,et al.  Lack of effectiveness of combined 5‐fluorouracil and methyl‐ccnu therapy in advanced colorectal cancer , 1977, Cancer.

[10]  L. Morgan,et al.  Methyl-CCNU versus methyl-CCNU and 5-fluorouracil in carcinoma of the large bowel. , 1977, Cancer treatment reports.

[11]  P. Woolley,et al.  5-Fluorouracil (5-FU), methyl-CCNU, and vincristine in the treatment of advanced colorectal cancer: phase II study utilizing weekly 5-FU. , 1976, Cancer treatment reports.

[12]  G. Falkson,et al.  Fluorouracil, methyl‐ccnu and vincristine in cancer of the colon , 1976, Cancer.

[13]  E. Gehan,et al.  Randomized prospective trial comparing 5-fluorouracil (NSC-19893) to 5-fluorouracil and methyl-CCNU (NSC-95441) in advanced gastrointestinal cancer. , 1976, Cancer treatment reports.

[14]  R. Hahn,et al.  Therapy for gastrointestinal cancer with the nitrosoureas alone and in drug combination. , 1976, Cancer treatment reports.

[15]  P. Lavin,et al.  Nitrosoureas: useful agents for the treatment of advanced gastrointestinal cancer. , 1976, Cancer treatment reports.

[16]  C. Moertel.  Clinical management of advanced gastrointestinal cancer , 1975, Cancer.

[17]  Schabel Fm.  Historical development and future promise of the nitrosoureas as anticancer agents. , 1973 .

[18]  Moertel Cg.  Therapy of advanced gastrointestinal cancer with the nitrosoureas. , 1973 .

[19]  F. Schabel,et al.  Success and failure in the treatment of solid tumors. 3. "Cure" of metastatic Lewis lung carcinoma with methyl-CCNU (NSC-95442) and surgery-chemotherapy. , 1972, Cancer chemotherapy reports.

[20]  Susan Rea Welch,et al.  Comprehensive criteria for assessing therapy-induced toxicity. , 1990, Cancer investigation.

[21]  N. Kemeny,et al.  Metastatic colorectal carcinoma: A prospective randomized trial of Methyl‐CCNU, 5‐fluorouracil (5‐FU) and vincristine (MOF) versus MOF plus streptozotocin (MOF‐strep) , 1983, Cancer.

[22]  P. Woolley.  Chapter 23 – CLINICAL USE OF NITROSOUREAS IN GASTROINTESTINAL CANCER , 1981 .

[23]  R. Hahn,et al.  Brief Communication: Therapy of Advanced Colorectal Cancer With a Combination of 5-Flourouracil, Methyl-l,3-cis(2-chlorethyl)-1-nitrosourea, and Vincristine , 1975 .