Carboplatin With or Without Thalidomide in Treating Patients With Ovarian Epithelial Cancer - Full Text View

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:	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:

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
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, Blann AD, Madhusudan S, Wilner S, Jenkins A, Han C, Kaur K, Perren T, Ganesan TS. A prospective randomised phase II trial of thalidomide with carboplatin compared with carboplatin alone as a first-line therapy in women with ovarian cancer, with evaluation of potential surrogate markers of angiogenesis. Eur J Gynaecol Oncol. 2011;32(3):253-8.

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 February 12, 2012