Nasal Cavity |
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Clinical Trial: Platinum-based Chemotherapy With or Without Paclitaxel in Treating Patients With Relapsed Ovarian Cancer
This study is no longer recruiting patients.
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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 | Treatment or Intervention | Phase |
|---|---|---|
| recurrent ovarian epithelial cancer peritoneal cavity cancer | Drug: carboplatin Drug: cisplatin Drug: paclitaxel Procedure: chemotherapy | Phase III |
MedlinePlus related topics: Ovarian Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Paclitaxel With Either Carboplatin or Cisplatin Versus Conventional Platinum-Based Chemotherapy in Patients With Relapsed Ovarian Epithelial or Peritoneal Cancer
OBJECTIVES:
- Compare survival of patients with relapsed ovarian epithelial or peritoneal cancer treated with paclitaxel and either carboplatin or cisplatin vs conventional platinum-based chemotherapy.
- Compare the quality of life and health economics of these regimens in these patients.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive platinum-based chemotherapy (that is familiar to the oncologist and used routinely by the center) comprising either cisplatin or carboplatin alone or cisplatin in combination with other drugs.
- Arm II: Patients receive paclitaxel IV over 3 hours followed by either carboplatin or cisplatin. 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: Both
Criteria
DISEASE CHARACTERISTICS:
- Ovarian epithelial cancer or serous peritoneal carcinoma that has relapsed after prior chemotherapy
- Progression-free interval (from end of last treatment) of at least 6 months
- Measurable disease not required
PATIENT CHARACTERISTICS: Age:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin less than 2 times normal
Renal:
- Not specified
Other:
- No sepsis
- No contraindication to chemotherapy
PRIOR CONCURRENT THERAPY: Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Location Information
United Kingdom, England
Middlesex Hospital- Meyerstein Institute, London, England, WIT 3AA, United Kingdom
Johnathan A. Ledermann, MD, Study Chair, Middlesex Hospital - Meyerstein Institute
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: May 2003
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002894
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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