• Cancer Chemother. Pharmacol. · Jan 2000

    Multicenter Study Clinical Trial

    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).

    • N Pavlidis, S Aamdal, A Awada, H Calvert, P Fumoleau, R Sorio, C Punt, J Verweij, A van Oosterom, R Morant, J Wanders, and A R Hanauske.
    • Department of Medical Oncology, Medical School, University of Ioannina, Greece. npavlid@cc.uoi.gr
    • Cancer Chemother. Pharmacol. 2000 Jan 1; 46 (2): 167-71.

    PurposeIn a phase II trial, the activity of carzelesin, a cyclopropylpyrroloindole prodrug analog, was assessed.Patients And MethodsCarzelesin was used as second- or third-line chemotherapy in patients with breast, ovarian, head and neck cancer and non-Hodgkin's lymphoma, and as first-line chemotherapy in patients with colorectal and gastric cancer and melanoma. The drug was given as a bolus infusion at a 4-weekly dose of 150 microg/m2. A total of 140 patients were entered and a total of 285 courses were administered.ResultsIn 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 very mild. Only one partial response in a patient with melanoma was seen.ConclusionsAt this dose and schedule carzelesin did not yield activity in the types of tumors studied.

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