Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
With
National Cancer Institute (NCI)
OBJECTIVES:
* Determine the time to progression of disease in patients with platinum-refractory or resistant ovarian epithelial carcinoma treated with thalidomide.
* Evaluate the quality of life of patients treated with this regimen.
OUTLINE: Patients receive oral thalidomide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 4 weeks.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 9-15 months.
* 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
Clareo Health | Thalidomide in Treating Patients With Refractory or Resistant Epithelial Ovarian Cancer