Phase II trial of 1,2-diaminocyclohexane-(4-carboxyphthalato) platinum(II) (DACCP) in colorectal carcinoma.

Overview

In an effort to investigate the antitumor activity of new cisplatin analogues, 1,2-diaminocyclohexane-(4-carboxyphthalato) platinum (II) (DACCP) was administered in a phase II disease-oriented trial to patients with advanced colorectal carcinoma. Six patients had not received prior chemotherapy, while four had received one drug, and two had received more than one drug. Primary sites of disease were in the liver only (8 patients), liver and lung (2 patients), and intra-abdominal (2 patients). Liver radionuclide scans and CT scans were the main parameter for evaluation. The drug was administered intravenously every 4 weeks at a dose of 640 mg/m2. There were no responses in 12 adequately treated patients. One patient had stable disease for 5 months. Nausea and vomiting was milder than that seen with cisplatin. A peripheral neuropathy was seen in four patients. Fever occurred in two patients and urticaria in one patient. No patient had significant drug-induced anemia, and renal dysfunction was not observed. DACCP at this dose and schedule demonstrated no efficacy as a single agent in the treatment of colorectal carcinoma.