Phase II study of 4'-deoxydoxorubicin (esorubicin) in advanced or metastatic adenocarcinoma of the stomach.

4'-deoxydoxorubicin (DxDx) was administered to 17 patients with locally advanced or metastatic gastric adenocarcinoma. Treatment cycles were repeated every 21 days. 15 eligible patients with a Karnofsky performance status of 50% or better (median: 70%) received at least one course of treatment; a median of 2 courses of DxDx was delivered (range 1 to 13).

Prospective randomized comparison of fluorouracil versus fluorouracil and high-dose continuous infusion leucovorin calcium for the treatment of advanced measurable colorectal cancer in patients previously unexposed to chemotherapy.

Seventy-nine patients with advanced, measurable, metastatic colorectal cancer previously unexposed to chemotherapy were randomly assigned to treatment with either fluorouracil (FUra) administered intravenously at a dose of 370 mg/m2/d for 5 days or the combination of FUra in the same dose and schedule with high-dose continuous infusion leucovorin calcium (500 mg/m2/d) beginning 24 hours before the first dose of FUra and continuing for 12 hours after the completion of FUra therapy. Patients whose disease progressed on treatment with FUra alone were, if eligible, crossed over to receive leucovorin and FUra. Three patients on the FUra plus leucovorin arm of the study were excluded from the analysis because they did not meet eligibility requirements.

Reversal of cancer chemotherapeutic resistance by amphotericin B--A broad phase I-II pilot study.

In order to determine if it was possible to reverse clinically evident chemotherapeutic drug-resistance, 51 evaluable patients received chemotherapy (in doses and schedules on which they had previously demonstrated tumor progression) together with amphotericin B (AMB). AMB was given in 1-, 2-, or 4-day courses. There was 1 complete response (2%), and 5 partial responses (10%).

Preliminary analysis of a randomized comparison of 5-fluorouracil versus 5-fluorouracil and high-dose continuous-infusion folinic acid in disseminated colorectal cancer.

In this study, 50 patients were randomly assigned to treatment with 5-fluorouracil (FUra) or FUra plus high-dose continuous-infusion folinic acid. Five of 27 evaluable patients in the FUra group versus 10 of 21 patients in the FUra plus folinic acid arm of the study had objective partial remissions, P = 0.02.

High-dose continuous infusion folinic acid and bolus 5-fluorouracil in patients with advanced colorectal cancer: a phase II study.

Encouraging results have recently been reported for studies using folinic acid in combination with 5-fluorouracil (5-FU) in the treatment of patients with gastrointestinal (GI) malignancies. Thirty-six patients with advanced colorectal cancer with unequivocal evidence of progression while treated with fluoropyrimidines were treated with a six-day continuous infusion of 500 mg/m2/d of folinic acid initiated 24 hours before a five-day course of 5-FU administered as an intravenous (IV) bolus of 370 mg/m2/d. An initial dose of 250 mg/m2/d of 5-FU was used in patients previously treated with ionizing radiation and/or a nitrosourea.

Effects of amphotericin B with combination chemotherapy on response rates and on survival in non-small cell carcinoma of the lung.

Thirty-seven patients with non-small cell carcinoma of the lung were randomized to receive doxorubicin, lomustine, hexamethylmelamine, and methotrexate (ACHM) or ACHM plus amphotericin B (AMB). The complete plus partial response rate was 39% for ACHM plus AMB, compared to 23% for ACHM alone. However, the median duration of complete or partial response was only 3.

Continuous five-day infusion of PALA and 5FU: a pilot phase II trial.

In order to determine whether a simultaneous infusion of N-(phospho-n-acetyl)-L-aspartic acid (PALA) was able to increase the rate of antitumor response to 5-fluorouracil (5-FU), a pilot study was conducted. Of 10 evaluable patients with previously drug-untreated colorectal carcinoma, there were only two partial responses, lasting 2.3 and 1.

Comparisons of Cooperative Group evaluation criteria for multiple-drug therapy for breast cancer.

The variability of response rates and durations for multiple-drug therapy for advanced breast cancer may be due in part to the evaulation criteria of the investigators. To assess the impact on outcome, a single data set comprising the patients registered in Central Oncology Group protocol 7020B was analyzed by the evaluation criteria of the Central Oncology Group, the Eastern Cooperative Oncology Group, the Southwest Oncology Group, and the Southeastern Cancer Study Group, as well as by a personally derived "flexible clinical interpretation of treatment benefit." The response rates and durations were quite similar by the criteria of all groups except those of the Southeastern Cancer Study Group, which gave lower rates and longer duration.

5-FU versus combination therapy with tubercidin, streptozotocin, and 5-FU in the treatment of pancreatic carcinomas: COG protocol 7230.

From May 1972 until May 1976, 105 patients were entered on Central Oncology Group protocol 7230 to compare the combination of streptozotocin, tubercidin, and 5-fluorouracil (5-FU) versus 5-FU alone in the treatment of adenocarcinoma and islet cell carcinoma of the pancreas. Twenty-nine were not evaluable. Thirty-six evaluable cases received 5-FU, and 40 received the combination, with no significant difference in time to progression or survival.

Yoshi 864 (1-propanol, 3,3'-iminodi-, dimethanesulfonate [ester], hydrochloride): a phase II study in solid tumors.

Two hundred and eight acceptable patients were treated with Yoshi 864 (2 mg/kg/day by iv push X 5 days repeated once every 6 weeks). Toxicity was minimal. There was an overall response rate of 11%.