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



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

For Condition: stage 3 ovarian epithelial cancer,stage 2 ovarian epithelial cancer,stage 4 ovarian epithelial cancer,stage 1 ovarian epithelial cancer
Status: Recruiting
Sponsor(s): Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford ,
Synopsis: 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: Randomizedphase II trial to compare the effectiveness of carboplatin with or without thalidomide in treating patients who have ovarian epithelial cancer.
Details: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
T.S.Ganesan,  Study Chair,  Oxford Radcliffe Hospital

Oxford Radcliffe Hospital *Recruiting*
Oxford,  England,  0X3 9DU
United Kingdom
Recruiting Adrian  Harris 44-1865-226-184

Radcliffe Infirmary NHS Trust *Recruiting*
Oxford,  England,  OX2 6HE
United Kingdom
Recruiting  Mills 44-1865-311-188


Additional Information:
Study ID Numbers:
  CDR0000067536;  ICRF-96.084,EU-99018
Study Start Date: 
Record last reviewed: March 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004876

Other Stage 4 Ovarian Epithelial Cancer Studies:
1. Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer

2. Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

3. Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum

4. Combination Chemotherapy in Treating Patients With Previously Untreated, Newly Diagnosed Epithelial Tumors

5. Biological Therapy in Treating Patients With Advanced Cancer

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

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