Phase I study of intravenous menogaril administered intermittently.

Eighteen women with metastatic breast cancer previously untreated with chemotherapy were entered on a phase II trial of intravenous menogaril, a new anthracycline derivative. Treatment was given at 140 mg/m2 on days 1 and 8 of each 28 day cycle. The most common toxicities were leukopenia in all patients and burning and phlebitis at infusion sites in 72%. Serial assessment of cardiac function by resting and stress gated blood pool scans showed temporary decrements in ejection fraction in only 2 patients (11%). The response rate to the therapy was 19% [95% CI 0-38%] including 1 complete and 2 partial responses. The median time to relapse among responders was 6.5 months. Mean survival in all patients entered was 15.8 months from date of entry. Menogaril at this dose and schedule has modest activity as first line therapy for metastatic breast cancer but also has significant marrow and local toxicity.

Section: Discussionsupporting

confidence: 81%

Phase II Studies

Kennedy¹,

Donehower²,

Grochow³

et al. 1990

“…The mechanism of action of menogaril appears unrelated to interaction with DNA [7]. Phase I studies have shown that the major (and dose limiting) toxicity is neutropenia with local phlebitis as the predominant non-hematologic side effect [8]. Phlebitis is decreased by dilution and by rapid infusion.…”

Section: Introductionmentioning

confidence: 99%

A phase II study of menogaril in low-grade non-Hodgkin's lymphoma

Skillings

Cripps

Eisenhauer³

et al. 1991

The NCI Canada Clinical Trials Group conducted a phase II study of menogaril given intravenously every 4 weeks in low-grade non-Hodgkin's lymphoma. Fifteen of 26 eligible patients had had no prior therapy. Partial responses were seen in 9 patients (35%). Toxicity was moderate including myelosuppression, nausea, phlebitis, alopecia, and lethargy. This drug has only modest activity in this potentially responsive group of patients.

“…Phase I trials of the intravenous formulation found myelosuppression to be dose limiting. Local venous toxicity, nausea, vomiting and mild hair loss were also noted [4,5].…”

Section: Introductionmentioning

confidence: 99%

Activity of intravenous menogaril in patients with previously untreated metastatic breast cancer

Eisenhauer¹,

Pritchard

Perrault

et al. 1990

We have carried out a phase II study of intravenous menogaril given every four weeks in a group of patients with breast cancer who had received no prior chemotherapy for metastatic disease. Myelosuppression, nausea and vomiting and local reactions were seen frequently. Six partial responses (median duration 154 days) were seen in 24 eligible patients. We conclude menogaril is active in breast cancer and recommend that because it can be delivered in high doses orally, future trials in this disease should focus on intense oral schedule.