Carboplatin With or Without Thalidomide in Treating Patients With Ovarian Epithelial Cancer
This study is currently recruiting participants.
Verified November 2011 by National Cancer Institute (NCI)
Sponsor:
Cancer Research UK
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004876
First received: March 7, 2000
Last updated: November 18, 2011
Last verified: November 2011
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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 [ 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 |
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 | |
| 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:
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 |
| Study First Received: | March 7, 2000 |
| Last Updated: | November 18, 2011 |
| Health Authority: | Unspecified |
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 Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms by Histologic Type Thalidomide |
Carboplatin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 17, 2013