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Thalidomide in Treating Patients With Gynecologic Sarcomas

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006005
First received: July 5, 2000
Last updated: June 20, 2013
Last verified: August 2004

July 5, 2000
June 20, 2013
September 2000
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Complete list of historical versions of study NCT00006005 on ClinicalTrials.gov Archive Site
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Thalidomide in Treating Patients With Gynecologic Sarcomas
Phase II Study of Thalidomide (NSC #66847) in Patients With Sarcomas of Gynecologic Origin

RATIONALE: Thalidomide may stop the growth of gynecologic sarcomas by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent gynecologic sarcomas.

OBJECTIVES:

  • Determine the impact on survival and the antitumor effects of thalidomide in patients with sarcomas or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin.
  • Determine the safety and side effect profiles of the target dose of this treatment regimen in this patient population.
  • Determine the antiangiogenic and immunologic effects of this treatment regimen in these patients.

OUTLINE: Patients receive oral thalidomide daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 18 months.

Interventional
Phase 2
Primary Purpose: Treatment
  • Endometrial Cancer
  • Sarcoma
Drug: thalidomide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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August 2006
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DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed sarcoma or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin not amenable to resection or radiotherapy
  • Measurable disease

    • Lesions accurately measured in at least 1 dimension of at least 20 mm in longest diameter with conventional techniques or at least 10 mm with helical CT scan
    • Histologically or cytologically confirmed neoplastic nature if solitary lesion
    • No nonmeasurable disease, defined as:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Unconfirmed abdominal masses not followed by imaging techniques
      • Cystic lesions
  • Documented recurrence or persistence following appropriate surgery, radiotherapy, and/or chemotherapy
  • Postmenopausal or status post hysterectomy

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,000/mm^3
  • Platelet count at least 50,000/mm^3

Hepatic:

  • Bilirubin normal
  • Transaminases less than 2.5 times upper limit of normal

Renal:

  • Creatinine less than 1.5 mg/dL

Other:

  • No grade 2 or greater peripheral neuropathy
  • No medical or social factors that would preclude study, including inability to take oral medication
  • No other serious illness requiring immediate therapy
  • Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas)

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • At least 30 days since any prior noncytotoxic experimental antiemetic or antifungal investigational drug
Female
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006005
CDR0000068013, NYGOG-99-001, NCI-314, NYOG-0102-073
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New York University Cancer Institute
National Cancer Institute (NCI)
Study Chair: Scott Wadler, MD Weill Medical College of Cornell University
National Cancer Institute (NCI)
August 2004

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