RATIONALE: Thalidomide may stop the growth of cancer 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 carcinosarcoma of the uterus.

Condition	Treatment or Intervention	Phase
recurrent uterine sarcoma uterine carcinosarcoma	Drug: thalidomide  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: biological response modifier therapy  Procedure: growth factor antagonist therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the antitumor cytostatic activity of thalidomide, as measured by the probability of progression-free survival (PFS) for at least 6 months, in patients with recurrent or persistent uterine carcinosarcoma.
• Determine the nature and degree of toxicity of this drug in these patients.
• Determine the partial and complete response rates in patients treated with this drug.
• Determine the duration of PFS and overall survival of patients treated with this drug.
• Determine the effect of this drug on initial performance status and histological grade in these patients.
• Determine the effects of this drug at 4 weeks on endogenous angiogenesis factors (vascular endothelial growth factor and basic fibroblast growth factor) in plasma and urine of these patients.
• Assess the association of endogenous angiogenesis factors with clinical outcome (PFS) in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days 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 19-51 patients will be accrued for this study within 3 years.

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed uterine sarcoma
• Carcinosarcoma (malignant mixed mullerian tumor)
• Homologous or heterologous type
• Recurrent or persistent with documented disease progression after prior local therapy
• At least 1 unidimensionally measurable target lesion
• At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR
• At least 10 mm by spiral CT scan
• Tumors within a previously irradiated field are considered non-target lesions
• Must have received 1 prior initial chemotherapy regimen (including high-dose, consolidation, or extended therapy after surgical or nonsurgical assessment) for carcinosarcoma
• No documented brain metastases since diagnosis of cancer
• Patients with stable CNS deficits are allowed provided that there is no evidence of brain metastases on CT scan or MRI
• Ineligible for a higher priority Gynecologic Oncology Group (GOG) protocol (if one exists), including any active phase III GOG protocol for the same patient population

PATIENT CHARACTERISTICS: Age:

• Not specified

Performance status:

• GOG 0-2 if received 1 prior therapy regimen
• GOG 0-1 if received 2 prior therapy regimens

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT no greater than 2.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN OR
• Creatinine clearance greater than 60 mL/min

Other:

• Not pregnant
• Negative pregnancy test
• Fertile patients must use at least 1 highly active method of contraception and 1 additional effective method of contraception for at least 4 weeks before, during, and for at least 4 weeks after study
• No seizure disorders since diagnosis of cancer
• Patients with a history of seizure disorders are allowed provided that the seizures have been stable (i.e., no seizure within the past 12 months) while on an appropriately monitored treatment regimen
• No active infection requiring antibiotics
• No greater than grade 1 sensory or motor neuropathy
• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy:

• At least 3 weeks since prior immunologic agents for uterine sarcoma
• No prior thalidomide

Chemotherapy:

• See Disease Characteristics
• At least 3 weeks since prior chemotherapy for uterine sarcoma and recovered
• No more than 1 prior cytotoxic chemotherapy regimen for recurrent or persistent uterine sarcoma
• No prior non-cytotoxic chemotherapy for recurrent or persistent uterine sarcoma

Endocrine therapy:

• At least 1 week since prior hormonal therapy for uterine sarcoma
• Concurrent hormone replacement therapy allowed

Radiotherapy:

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy for uterine sarcoma and recovered
• No prior radiotherapy to more than 25% of marrow-bearing areas

Surgery:

• See Disease Characteristics
• Recovered from prior surgery

Other:

• At least 3 weeks since any other prior therapy for uterine sarcoma
• No prior anticancer therapy that would preclude study

Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States
California
      Chao Family Comprehensive Cancer Center, Orange,  California,  92868,  United States
      Community Hospital of Los Gatos, Los Gatos,  California,  95032,  United States
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80010,  United States
Illinois
      Rush-Presbyterian-St. Luke's Medical Center, Chicago,  Illinois,  60612-3864,  United States
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States
Iowa
      Holden Comprehensive Cancer Center, Iowa City,  Iowa,  52242-1009,  United States
Maryland
      Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda,  Maryland,  20892-1182,  United States
Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States
Missouri
      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States
      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States
New Jersey
      Cooper University Hospital, Camden,  New Jersey,  08103-1489,  United States
New York
      State University of New York Health Science Center at Brooklyn, Brooklyn,  New York,  11203,  United States
      State University of New York Health Sciences Center - Stony Brook, Stony Brook,  New York,  11794-8091,  United States
North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1065,  United States
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
Ohio
      Barrett Cancer Center, Cincinnati,  Ohio,  45267-0526,  United States
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States
      Ireland Cancer Center, Cleveland,  Ohio,  44106,  United States
Oklahoma
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73190,  United States
      University of Oklahoma Health Sciences Center, Oklahoma City,  Oklahoma,  73190,  United States
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001-3788,  United States
      Abramson Cancer Center of the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104-4283,  United States
      Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107-5541,  United States
      Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033-0850,  United States
Texas
      CCOP - M.D. Anderson Research Base, Houston,  Texas,  77030-4009,  United States
      Simmons Cancer Center - Dallas, Dallas,  Texas,  75390-9032,  United States
      University of Texas Medical Branch, Galveston,  Texas,  77555-0587,  United States
Vermont
      Fletcher Allen Health Care - Medical Center Campus, Burlington,  Vermont,  05401,  United States
Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States
Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6188,  United States
Canada, Alberta
      Tom Baker Cancer Center - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada
Norway
      Norwegian Radium Hospital, Oslo,  N-0310,  Norway
United Kingdom, England
      University of Birmingham, Birmingham,  England,  B15 2TT,  United Kingdom

Study chairs or principal investigators

Scott McMeekin, MD,  Study Chair,  University of Oklahoma Health Sciences Center   

Study ID Numbers:  CDR0000068967; GOG-0230-B
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  October 11, 2001
ClinicalTrials.gov Identifier:  NCT00025506
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08