Thalidomide in Treating Patients With Refractory or Resistant Epithelial Ovarian Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: thalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Thalidomide in Patients With Ovarian Cancer |
| Study Start Date: | January 2001 |
| Primary Completion Date: | March 2004 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | David R. Spriggs, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00016224 History of Changes |
| Other Study ID Numbers: | CDR0000068611, MSKCC-01006, NCI-G01-1943 |
| Study First Received: | May 6, 2001 |
| Last Updated: | December 13, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent ovarian epithelial cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Thalidomide 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 May 19, 2013