Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	Over 18	Other	ICRF-96.084 EU-99018, NCT00004876

Objectives

1. Determine the safety of carboplatin and thalidomide in patients with stage IC-IV ovarian cancer.
2. Determine the antiangiogenic effect of thalidomide in this patient population.
3. Compare the efficacy of carboplatin with or without thalidomide in this patient population.

Entry Criteria

Disease Characteristics:

• Histologically confirmed stage IC-IV ovarian epithelial cancer



• Post-menopausal

  OR




• Prior bilateral salpingo-oophorectomy and/or total abdominal hysterectomy

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

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

Expected Enrollment

Approximately 30 patients will be accrued for this study.

Outcomes

Safety
Response
Markers of angiogenesis

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.

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.

Trial Contact Information

Trial Lead Organizations

Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford

T.S. Ganesan, MD, Protocol chair		Ph: 44-1865-222-458 Email: ganesan@cancer.org.uk

United Kingdom
England
	Oxford
	Oxford Radcliffe Hospital
		Adrian Harris, MD	Ph:  44-1865-226-184
		D.C. Talbot, MD, PhD, FRCP	Ph:  865-44-22-6183
		T.S. Ganesan, MD	Ph:  44-1865-222-458
			Email: ganesan@cancer.org.uk

Registry Information
Official Title		A Randomized Study Comparing Carboplatin and Thalidomide with Carboplatin Alone in Patients with Stage Ic - IV Ovarian Cancer
Trial Start Date		1999-08-02
Registered in ClinicalTrials.gov		NCT00004876
Date Submitted to PDQ		1999-10-08
Information Last Verified		2007-05-17

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