Phase II trial of Oxaliplatin and 5-Fluorouracil/Leucovorin combination in epithelial ovarian carcinoma relapsing within 2 years of platinum-based therapy

Sundar, Santhanam, Symonds, R. P., Decatris, Marios P., Kumar, D. M., Osman, A., Vasanthan, S., & O'Byrne, Kenneth J. (2004) Phase II trial of Oxaliplatin and 5-Fluorouracil/Leucovorin combination in epithelial ovarian carcinoma relapsing within 2 years of platinum-based therapy. Gynecologic Oncology, 94(2), pp. 502-508.

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Objective To evaluate the efficacy and toxicity of Oxaliplatin and 5-Fluorouracil (5-FU)/Leucovorin (LV) combination in ovarian cancer relapsing within 2 years of prior platinum-based chemotherapy in a phase II trial.

Methods Eligible patients had at least one prior platinum-based chemotherapy regimen, elevated CA-125 ≥ 60 IU/l, radiological evidence of disease progression and adequate hepatic, renal and bone marrow function. Patients with raised CA-125 levels alone as marker of disease relapse were not eligible. Oxaliplatin (85 mg/m 2) was given on day 1, and 5-Fluorouracil (370 mg/m 2) and Leucovorin (30 mg) was given on days 1 and 8 of a 14-day cycle.

Results Twenty-seven patients were enrolled. The median age was 57 years (range 42-74 years). The median platinum-free interval (PFI) was 5 months (range 0-17 months) with only 30% of patients being platinum sensitive (PFI > 6 months). Six patients (22%) had two prior regimens of chemotherapy. A total of 191 cycles were administered (median 7; range 2-12). All patients were evaluable for toxicity. The following grade 3/4 toxicities were noted: anemia 4%; neutropenia 15%; thrombocytopenia 11%; neurotoxicity 8%; lethargy 4%; diarrhea 4%; hypokalemia 11%; hypomagnesemia 11%. Among 27 enrolled patients, 20 patients were evaluable for response by WHO criteria and 25 patients were evaluable by Rustin's CA-125 criteria. The overall response rate (RR) by WHO criteria was 30% (95% CI: 15- 52) [three complete responses (CRs) and three partial responses (PRs)]. The CA-125 response rate was 56% (95% CI: 37-73). Significantly, a 25% (95% CI: 9-53) radiological and a 50% (95% CI: 28-72) CA-125 response rate were noted in platinum resistant patients (PFI < 6 months). The median response duration was 4 months (range 3-12) and the median overall survival was 10 months.

Conclusion Oxaliplatin and 5-Fluorouracil/ Leucovorin combination has a good safety profile and is active in platinum-pretreated advanced epithelial ovarian cancer. © 2004 Elsevier Inc. All rights reserved.

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ID Code: 65717
Item Type: Journal Article
Refereed: Yes
Additional URLs:
Keywords: Chemotherapy, Fluorouracil, Ovarian cancer, Oxaliplatin, Phase II, Platinum resistance, antiemetic agent, antineoplastic agent, dexamethasone, metoclopramide, ondansetron, platinum derivative, adult, aged, alopecia, anemia, antigen detection, article, blood analysis, blood toxicity, cancer combination chemotherapy, cancer growth, cancer recurrence, cancer survival, chemotherapy induced emesis, clinical article, clinical trial, constipation, controlled clinical trial, controlled study, diarrhea, drug efficacy, drug safety, drug sensitivity, female, gastrointestinal symptom, gastrointestinal toxicity, human, hypokalemia, hypomagnesemia, infection, kidney function, lethargy, leukopenia, liver function, long term care, nausea, neurotoxicity, neutropenia, ovary carcinoma, phase 2 clinical trial, priority journal, radiodiagnosis, sensitivity analysis, sensory dysfunction, side effect, skin toxicity, stomatitis, thrombocytopenia, world health organization, Antineoplastic Combined Chemotherapy Protocols, CA-125 Antigen, Disease Progression, Humans, Leucovorin, Middle Aged, Organoplatinum Compounds, Ovarian Neoplasms
DOI: 10.1016/j.ygyno.2004.04.020
ISSN: 0090-8258
Divisions: Current > Schools > School of Biomedical Sciences
Current > QUT Faculties and Divisions > Faculty of Health
Current > Institutes > Institute of Health and Biomedical Innovation
Copyright Owner: Copyright 2004 Academic Press
Deposited On: 07 Jan 2014 06:35
Last Modified: 09 Jan 2014 01:37

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