Carboplatin With or Without Thalidomide in Treating Patients With Ovarian Epithelial Cancer

Cancer Research UK (CRUK)

Status and phase: Completed; Phase 2

Conditions: Ovarian Cancer

Treatments: Drug: carboplatin; Drug: thalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT00004876

ICRF-96.084

EU-99018

CDR0000067536

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of ovarian cancer by stopping blood flow to the tumor.

PURPOSE: This randomized phase II trial is studying how well giving carboplatin together with thalidomide works compared to carboplatin alone in treating patients with ovarian epithelial cancer.

Full description

OBJECTIVES:

• Determine the safety of carboplatin and thalidomide in patients with stage IC-IV ovarian cancer.
• Determine the antiangiogenic effect of thalidomide in this patient population.
• Compare the efficacy of carboplatin with or without thalidomide in this patient population.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.

• Arm I: Patients receive carboplatin IV over 1 hour. Treatment continues every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive carboplatin as in arm I. Patients receive thalidomide orally once daily. Thalidomide treatment continues for up to 24 weeks commencing on the first day of carboplatin therapy and ceasing 4 weeks after the last course of carboplatin.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IC-IV ovarian epithelial cancer
• Post-menopausal OR
• Prior bilateral salpingo-oophorectomy and/or total abdominal hysterectomy

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No other concurrent invasive malignancies
• Not pregnant
• No diabetes mellitus
• No chronic neurological disease causing peripheral neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No other concurrent cytotoxic agents

Endocrine therapy:

• Not specified

Radiotherapy:

• Concurrent local radiotherapy for treatment of secondary disease sites allowed

Surgery:

• See Disease Characteristics