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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)
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer Drug: carboplatin Drug: thalidomide Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Study Comparing Carboplatin and Thalidomide With Carboplatin Alone in Patients With Stage Ic - IV Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety
  • Response
  • Markers of angiogenesis

Estimated Enrollment: 30
Study Start Date: August 1999
Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004876


Locations
United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Sponsors and Collaborators
Cancer Research UK
Investigators
Study Chair: T.S. Ganesan, MD Oxford University Hospitals NHS Trust
  More Information

Publications:
Muthuramalingam SR, Braybrooke JP, Madhusudan S, et al.: A randomised phase two study of carboplatin versus carboplatin and thalidomide in patients with ovarian cancer, with evaluation of potential surrogate markers of angiogenesis. [Abstract] Int J Gynecol Cancer 14 (Suppl 1): A-303, 86, 2004.

ClinicalTrials.gov Identifier: NCT00004876     History of Changes
Other Study ID Numbers: CDR0000067536
ICRF-96.084
EU-99018
First Submitted: March 7, 2000
First Posted: January 27, 2003
Last Update Posted: August 26, 2013
Last Verified: November 2011

Keywords provided by National Cancer Institute (NCI):
stage IV ovarian epithelial cancer
stage IC ovarian epithelial cancer
stage IIA ovarian epithelial cancer
stage IIB ovarian epithelial cancer
stage IIC ovarian epithelial cancer
stage IIIA ovarian epithelial cancer
stage IIIB ovarian epithelial cancer
stage IIIC ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Thalidomide
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors