Overview
Thalidomide in Treating Patients With Refractory or Resistant Epithelial Ovarian Cancer
Status:
Completed
Completed
Trial end date:
2004-03-01
2004-03-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
RATIONALE: Drugs such as thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating women who have epithelial ovarian cancer that has not responded to previous therapy.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Memorial Sloan Kettering Cancer CenterCollaborator:
National Cancer Institute (NCI)Treatments:
Thalidomide
Criteria
DISEASE CHARACTERISTICS:- Histologically confirmed ovarian epithelial carcinoma
- Platinum-refractory or resistant disease
- At least 1 prior non-platinum chemotherapy agent required
- Prior bilateral salpingo-oophorectomy and hysterectomy required
- Bidimensionally measurable disease OR CA-125 greater than 100 units/mm3
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- Karnofsky 70-100%
Life expectancy:
- More than 3 months
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin normal
- AST no greater than 2.5 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than 1.5 times ULN OR
- Creatinine clearance at least 50 mL/min
Other:
- No other prior malignancy except non-melanoma skin cancer unless curatively treated
with no evidence of disease within the past 5 years and at low risk for recurrence
- No other clinical circumstances that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior biologic therapy and recovered
- No prior thalidomide
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior cytotoxic therapy and recovered
Endocrine therapy:
- At least 4 weeks since prior hormonal therapy and recovered
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- See Disease Characteristics
- At least 4 weeks since prior major surgery