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Thalidomide in Treating Patients With Refractory or Resistant Epithelial Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
thalidomide
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent ovarian epithelial cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2001
Last Updated
June 17, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00016224
Brief Title
Thalidomide in Treating Patients With Refractory or Resistant Epithelial Ovarian Cancer
Official Title
Phase II Trial of Thalidomide in Patients With Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
March 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
recurrent ovarian epithelial cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
thalidomide

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R. Spriggs, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Thalidomide in Treating Patients With Refractory or Resistant Epithelial Ovarian Cancer

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