ledoxantrone and Adenocarcinoma

A phase II trial of CI-958 (NSC #635371), a new benzothiopyranoindazole was performed in patients with hormone refractory prostate carcinoma using prostate specific antigen (PSA) levels for response assessment. Twenty-two patients were entered on this study and twenty one were eligible. Toxicity consisted mainly of granulocytopenia (71% grade 3 or 4), but there were no significant infections. Two patients were removed from study due to asymptomatic decreases in cardiac ejection fraction. Of 21 evaluable patients, there were four responders (19%, CI 0-35%).

Topics: Adenocarcinoma; Adult; Aged; Aged, 80 and over; Drug Resistance, Neoplasm; Drugs, Investigational; Humans; Indazoles; Male; Middle Aged; Neoplasms, Hormone-Dependent; Prostate-Specific Antigen; Prostatic Neoplasms

In a multicenter, phase II trial, CI-958, a benzothiopyranoindazole DNA intercalator, was administered to 18 patients who had not received prior chemotherapy for metastatic colorectal cancer. The drug was given by intravenous infusion at a dose of 700 mg/m2 every 21 days. There were no objective responses. Grades III and IV toxic effects were limited to granulocytopenia in 42% of courses and anemia in 5% of courses. There was one case of grade III increase in transaminases. Our results show that at this dose and schedule, CI-958 lacks activity against colorectal cancer.

Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Agents; Colorectal Neoplasms; Female; Humans; Indazoles; Infusions, Intravenous; Male; Middle Aged

We completed a phase II trial of CI-958 (NSC 635371) in patients with advanced colorectal cancer given at a dose of 700 mg/m2 every 21 days.. All 15 patients had metastatic disease and had been previously treated with one 5-fluorouracil-based regimen in an adjuvant (six) or metastatic (nine) setting.. None of the patients treated with CI-958 had an objective response to treatment. Median survival was 4.8 months after the start of treatment. Leukopenia was the major toxicity, but no patient experienced febrile neutropenia. An acute febrile reaction was seen after infusion in four of the first nine patients treated. This was abrogated by pretreatment with dexamethasone in the remaining patients.. CI-958 was not effective at this dose and schedule in patients with previously treated advanced colorectal cancer.

Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Agents; Colorectal Neoplasms; Drug Administration Schedule; Female; Humans; Indazoles; Intercalating Agents; Leukopenia; Male; Middle Aged