Phase II trial of CI-980 in patients with disseminated malignant melanoma and no prior chemotherapy. A Southwest Oncology Group study |
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Authors: | Whitehead R P Unger J M Flaherty L E Eckardt J R Taylor S A Didolkar M S Samlowski W Sondak V K |
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Institution: | (1) University of Texas Medical Branch at Galveston, Galveston, TX, USA;(2) Southwest Oncology Group Statistical Center, Seattle, WA, USA;(3) Wayne State University Medican Center, Detroit, MI, USA;(4) St. Louis-Cape Girardeau CCOP, St. Louis, MO, USA;(5) University of Kansas Medical Center, Kansas City, KS, USA;(6) Temple University, Philadelphia, PA, USA;(7) University of Utah Medical Center, Salt Lake City, UT, USA;(8) University of Michigan Medican Center, Ann Arbor, MI, USA |
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Abstract: | Malignant melanoma is increasing infrequency at a rapid rate in the UnitedStates. Metastatic disease ischemoresistant with DTIC considered themost active single agent. CI-980 is asynthetic mitotic inhibitor that blocks theassembly of tubulin and microtubules. Ithas shown cytotoxic activity against abroad spectrum of murine and human tumorcell tines. CI-980 can cross the bloodbrain barrier, is effective when givenorally or parenterally, and is activeagainst multidrug resistant cell linesoverexpressing P-glycoprotein. In thistrial, patients with disseminated melanomawith measurable disease, SWOG performancestatus of 0–1, no prior chemotherapy orimmunotherapy for metastatic disease, andadequate hepatic and renal function, wereenrolled. Treatment with CI-980 was givenby 72 h continuous IV infusion at a doseof 4.5 mg/m2/day, days 1–3 every 21 days. Twenty-four patients were registered onthis study with no patients ineligible. They ranged in age from 33–78 withperformance status of 0 in 15 patients and1 in 9 patients. Nineteen patients hadvisceral disease with 12 having liverinvolvement. There were no confirmedresponses. The overall response rate was0% (95% CI 0%–14%). The medianoverall survival is eleven months (95% CI4–14 months). The most common toxicitieswere hematologic and consisted ofleukopenia/granulocytopenia and anemia,with nausea/vomiting andmalaise/fatigue/weakness also frequent. CI-980 administered at this dose andschedule has insufficient activity in thetreatment of disseminated malignantmelanoma to warrant furtherinvestigation. |
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Keywords: | melanoma CI-980 phase II trial |
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