Phase II trial of docetaxel (D) / carboplatin (C) as treatment for first relapsed platinum-sensitive stage III/IV ovarian cancer

Abstract

5051 Background: The optimal therapy to treat relapsed ovarian cancer remains elusive and patients who relapse ≥ 6 months after initial therapy are usually treated with platinum-containing salvage therapy. Docetaxel (D) alone has demonstrated some clinical responses in such patients. In a number of different cancers, treatment after Paclitaxel with D has yielded impressive clinical responses. Thus, it seemed reasonable to combine D and Carboplatin (C) to treat patients in first relapse with platinum-sensitive ovarian cancer. Methods: 21 patients have begun treatment with D 80 mg/m2 IV over 1 hour followed by C AUC6 (calculated by Calvert formula) IV over 30 minutes. Cycles were given every 21 days for a total of 6. Dose modifications occurred for hematological, neurological, hepatic or renal toxicity. Patients began therapy if platelet count was ≥ 100,000 cells/ul, ANC ≥ 1500 cells/ul, Total Bilirupin <2.0 mg/dl, SGPT/SGOT ≤ 1.5 X ULN with alkaline phosphatase ≤ 2.5 X ULN or SGOT/SGPT ≤ 5 X ULN with normal alkaline phosphatase. Karnofsky status had to be ≥ 60%. Grading of toxicity was according to NCI CTC. Results: Of the evaluated patients, 74% remain alive, with a median follow-up of 20.9 months (5–48). Fifty-eight % have progressed or relapsed. Initial response rates included 36.8% achieving a CR, and 31.6% a PR (the total CR+PR rate = 68.4%). An additional 15.8% had SD. Three patients who achieved a CR relapsed at 489, 261 and 95 days, the other four remain in CR. Eighty-four % of the patients developed grade 4 neutropenia. There were three separate cases of grade 3 non-hematological toxicity, including allergic reaction, nausea/dehydration and dermatitis. Thirty-two % of the patients developed an infection. One patient stopped therapy at physician's request for decreased performance status. Conclusions: Docetaxel and Carboplatin is not only a very well tolerated regimen with neutropenia the most common side effect but also a very active regimen in treating patients with first relapsed platinum-sensitive ovarian cancer. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis Aventis