ABSTRACT
OBJECTIVE: Results of the ICON4/AGO-OVAR-2.2 trial suggest that a platinum/taxane combination provides a survival benefit in relapsed, platinum-sensitive ovarian cancer compared to platinum alone. The optimal specific combination has yet to be determined. The current study evaluates weekly docetaxel and carboplatin in this setting. METHODS: Using a prospective phase II design, patients received weekly docetaxel (35 mg/m2) and carboplatin (AUC=2) administered days 1, 8, and 15 of a 28-day cycle. Initial treatment with a platinum-based regimen was required, with a treatment-free interval of at least 3 months. Patients could have received one prior regimen for recurrence. Biologically evaluable disease (CA-125) could be followed only if measurable disease was not present. Quality of life analysis utilized the FACT-O and FACT/GOG-Ntx scales. RESULTS: Thirty-six patients enrolled in the trial over 29 months. The majority had ovarian cancer (89%) and stage III/IV (97%) disease, with a median initial disease-free interval of 12 months. Most subjects were treated for first recurrence (81%) and had measurable disease (58%). The overall response rate was 67% (PR=52%, CR=15%), with 22% stable disease. Grade 3/4 neutropenia was common (48%) while serious anemia and thrombocytopenia were not. Neuropathy was generally mild and manageable. Carboplatin hypersensitivity led to 11 subjects coming off trial (31%). Diphenhydramine premedication produced a nonsignificant decrease in reaction rate. There was no detectable difference in quality of life due to therapy. CONCLUSION: The weekly regimen of carboplatin and docetaxel has a good response rate with an acceptable toxicity profile.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Neoplasm Recurrence, Local/drug therapy , Ovarian Neoplasms/drug therapy , Peritoneal Neoplasms/drug therapy , Aged , Aged, 80 and over , Carboplatin/administration & dosage , Docetaxel , Drug Administration Schedule , Female , Humans , Infusions, Intravenous , Middle Aged , Neoplasm Recurrence, Local/pathology , Ovarian Neoplasms/pathology , Peritoneal Neoplasms/pathology , Quality of Life , Taxoids/administration & dosageABSTRACT
OBJECTIVE: This was a phase II study of perillyl alcohol in the treatment of advanced ovarian cancer. The primary endpoint was to evaluate the 6-month progression-free rate of perillyl alcohol as compared with historic controls. Secondary objectives were to evaluate the objective response rate, time to progression and survival, dropout rate, and number of cycles administered; define the qualitative nature of acute and chronic toxicities; and evaluate the effect of perillyl alcohol on triglycerides and total, HDL, and LDL cholesterol levels. Methods. Women who had received prior platinum-based therapy and had residual or recurrent disease were eligible. Perillyl alcohol was administered orally, four times daily, at a dose of 1200 mg/m(2). This was repeated until disease progression or unacceptable toxicity was experienced. RESULTS: The 6-month progression-free rate was 17%. None of the patients achieved a complete or partial response. The median progression-free survival was 1.7 months. The median overall survival was 9.1 months. Compliance was greater than 90% but gastrointestinal toxicity (grade 1-2 nausea, satiety, eructation in 70%) and fatigue (grade 1-2 in 40%) were common and limited the ability to escalate the dose from 1200 to 1500 mg/m(2). CONCLUSION: Perillyl alcohol administered at this dose and formulation did not exhibit signs of extending the time-to-progression in patients with advanced ovarian carcinoma.
