Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Thalidomide in Treating Patients With Refractory or Resistant Epithelial Ovarian Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00016224
First received: May 6, 2001
Last updated: June 17, 2013
Last verified: June 2013

May 6, 2001
June 17, 2013
January 2001
March 2004   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00016224 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Thalidomide in Treating Patients With Refractory or Resistant Epithelial Ovarian Cancer
Phase II Trial of Thalidomide in Patients With Ovarian Cancer

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Ovarian Cancer
Drug: thalidomide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
March 2004
March 2004   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00016224
01-006, CDR0000068611, NCI-G01-1943
Not Provided
Not Provided
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: David R. Spriggs, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP