Full Text View
Tabular View
No Study Results Posted
Related Studies
Carboplatin With or Without Thalidomide in Treating Patients With Ovarian Epithelial Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2007
First Received: March 7, 2000   Last Updated: July 23, 2008   History of Changes
Sponsor: Cancer Research UK
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004876
  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 II

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
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:

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Thalidomide Carboplatin
U.S. FDA Resources

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

Primary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
  • Response [ Designated as safety issue: No ]
  • Markers of angiogenesis [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004876

Locations
United Kingdom, England
Oxford Radcliffe Hospital Recruiting
Oxford, England, United Kingdom, 0X3 9DU
Contact: Adrian L. Harris, MD     44-1865-226-184        
Sponsors and Collaborators
Cancer Research UK
Investigators
Study Chair: T.S. Ganesan, MD Oxford Radcliffe Hospital
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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.

Study ID Numbers: CDR0000067536, ICRF-96.084, EU-99018
Study First Received: March 7, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00004876     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer

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

ClinicalTrials.gov processed this record on November 27, 2009



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services