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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004876
First Posted: January 27, 2003
Last Update Posted: August 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
March 7, 2000
January 27, 2003
August 26, 2013
August 1999
Not Provided
  • Safety
  • Response
  • Markers of angiogenesis
Not Provided
Complete list of historical versions of study NCT00004876 on ClinicalTrials.gov Archive Site
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Carboplatin With or Without Thalidomide in Treating Patients With Ovarian Epithelial Cancer
A Randomized Study Comparing Carboplatin and Thalidomide With Carboplatin Alone in Patients With Stage Ic - IV Ovarian Cancer

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.

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.

Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
Ovarian Cancer
  • Drug: carboplatin
  • Drug: thalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00004876
CDR0000067536
ICRF-96.084
EU-99018
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Cancer Research UK
Not Provided
Study Chair: T.S. Ganesan, MD Oxford University Hospitals NHS Trust
National Cancer Institute (NCI)
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP