Phase II trial of CI-980 in patients with disseminated malignant melanoma and no prior chemotherapy: A Southwest Oncology Group study

Robert P. Whitehead, Joseph M. Unger, Lawrence E. Flaherty, John R. Eckardt, Sarah A. Taylor, Mukund S. Didolkar, Wolfram Samlowski, Vernon K. Sondak

Research output: Contribution to journalArticlepeer-review

Abstract

Malignant melanoma is increasing in frequency at a rapid rate in the United States. Metastatic disease is chemoresistant with DTIC considered the most active single agent. CI-980 is a synthetic mitotic inhibitor that blocks the assembly of tubulin and microtubules. It has shown cytotoxic activity against a broad spectrum of murine and human tumor cell tines. CI-980 can cross the blood brain barrier, is effective when given orally or parenterally, and is active against multidrug resistant cell lines overexpressing P-glycoprotein. In this trial, patients with disseminated melanoma with measurable disease, SWOG performance status of 0-1, no prior chemotherapy or immunotherapy for metastatic disease, and adequate hepatic and renal function, were enrolled. Treatment with CI-980 was given by 72 h continuous IV infusion at a dose of 4.5 mg/m2/day, days 1-3 every 21 days. Twenty-four patients were registered on this study with no patients ineligible. They ranged in age from 33-78 with performance status of 0 in 15 patients and 1 in 9 patients. Nineteen patients had visceral disease with 12 having liver involvement. There were no confirmed responses. The overall response rate was 0% (95% CI 0%-14%). The median overall survival is eleven months (95% CI 4-14 months). The most common toxicities were hematologic and consisted of leukopenia/granulocytopenia and anemia, with nausea/vomiting and malaise/fatigue/weakness also frequent. CI-980 administered at this dose and schedule has insufficient activity in the treatment of disseminated malignant melanoma to warrant further investigation.

Original languageEnglish (US)
Pages (from-to)239-243
Number of pages5
JournalInvestigational New Drugs
Volume19
Issue number3
DOIs
StatePublished - 2001

Keywords

  • CI-980
  • Melanoma
  • Phase II trial

ASJC Scopus subject areas

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

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