Carzelesin phase II study in advanced breast, ovarian, colorectal, gastric, head and neck cancer, non-Hodgkin's lymphoma and malignant melanoma: a study of the EORTC early clinical studies group (ECSG)

Purpose: In a phase II trial, the activity of carzelesin, a cyclopropylpyrr oloindole prodrug analog, was assessed. Patients and methods:Carzelesin was used as second- or third-line chemotherapy in patients with breast, ovaria n, head and neck cancer and non-Hodgkin's lymphoma, and as first-line chemo therapy in patients with colorectal and gastric cancer and melanoma. The dr ug was given as a bolus infusion at a 4-weekly dose of 150 mu g/m(2). A tot al of 140 patients were entered and a total of 285 courses were administere d. Results: In general, the compound was well tolerated. Myelotoxicity was the most common toxicity. Grade 3 and 4 leukopenia was observed in 18.6% of the courses, neutropenia in 20.3%, thrombocytopenia in 16.2% and anemia in 8.7%. Double nadirs were seen in a total of 41 courses for neutrophils, in 40 for leukocytes and in 3 for platelets. Non-hematological toxicity was v ery mild. Only one partial response in a patient with melanoma was seen. Co nclusions: At this dose and schedule carzelesin did not yield activity in t he types of turners studied.