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| Sponsored by: |
Medical Research Council |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002894 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of platinum-based chemotherapy with or without paclitaxel in treating patients with relapsed ovarian epithelial cancer.
| Condition | Intervention | Phase |
|
Ovarian Cancer Peritoneal Cavity Cancer |
Drug: carboplatin Drug: cisplatin Drug: paclitaxel |
Phase III |
| MedlinePlus related topics: | Cancer Ovarian Cancer |
| Drug Information available for: | Carboplatin Cisplatin Paclitaxel |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A RANDOMISED TRIAL OF PACLITAXEL (TAXOL) IN COMBINATION WITH PLATINUM CHEMOTHERAPY VS. CONVENTIONAL PLATINUM-BASED CHEMOTHERAPY IN THE TREATMENT OF WOMEN WITH RELAPSED OVARIAN CANCER |
| Estimated Enrollment: | 800 |
| Study Start Date: | March 1996 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
Treatment for both arms continues every 3 weeks for up to 6 courses in the absence of unacceptable toxicity.
Quality of life is assessed.
Patients are followed at 6 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 800 patients will be accrued for this study.
Eligibility
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Ovarian epithelial cancer or serous peritoneal carcinoma that has relapsed after prior chemotherapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United Kingdom, England | |||||
| Middlesex Hospital- Meyerstein Institute | |||||
| London, England, United Kingdom, WIT 3AA | |||||
| Medical Research Council |
| Study Chair: | Jonathan A. Ledermann, MD | University College London Hospitals |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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Ledermann JA: Randomised trial of paclitaxel in combination with platinum chemotherapy versus platinum-based chemotherapy in the treatment of relapsed ovarian cancer (ICON4/OVAR2.2). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1794, 446, 2003.
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Parmar MK, Ledermann JA, Colombo N, du Bois A, Delaloye JF, Kristensen GB, Wheeler S, Swart AM, Qian W, Torri V, Floriani I, Jayson G, Lamont A, Trope C; ICON and AGO Collaborators. Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. Lancet. 2003 Jun 21;361(9375):2099-106.
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| Study ID Numbers: | CDR0000065217, MRC-ICON4, EU-96051, ISRCTN47434271 |
| First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002894 |
| Health Authority: | United States: Federal Government |
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