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Platinum-based Chemotherapy With or Without Paclitaxel in Treating Patients With Relapsed Ovarian Cancer - Article


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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.

Sponsored by: Medical Research Council
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

OBJECTIVES:

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

Study chairs or principal investigators

Johnathan A. Ledermann, MD,  Study Chair,  Middlesex Hospital - Meyerstein Institute   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065217; MRC-ICON4; EU-96051
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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December 6, 2009



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