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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


Phase 3
N/A
N/A
Open (Enrolling)
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jonathan A. Ledermann, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University College London Hospitals

Authority:

United States: Federal Government

Study ID:

CDR0000065217

NCT ID:

NCT00002894

Start Date:

March 1996

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

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