Full Text View
Tabular View
No Study Results Posted
Related Studies
Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus
This study has been completed.
First Received: October 11, 2001   Last Updated: August 6, 2008   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025220
  Purpose

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 cancer of the uterus.


Condition Intervention Phase
Sarcoma
Drug: thalidomide
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Evalutaion of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2001
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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 leiomyosarcoma.
  • Determine the nature and degree of the 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 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 4 weeks 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 22-60 patients will be accrued for this study within 7-21 months.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary uterine leiomyosarcoma (LMS) that is refractory to curative therapy or established treatments

    • Recurrent or persistent disease
  • 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
  • No smooth muscle tumor of uncertain malignant potential, including metastatic or recurrent disease from such a tumor
  • Must have received 1 prior initial chemotherapy regimen (including high-dose, consolidation, or extended therapy after surgical or nonsurgical assessment) for uterine LMS
  • Ineligible for a higher priority Gynecological Oncology Group (GOG) protocol (if one exists), including any active phase III protocol for the same patient population
  • No documented brain metastases since diagnosis of cancer

    • Patients with stable CNS deficits are allowed provided there are no brain metastases, as confirmed by CT scan or MRI

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:

  • No documented 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 prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use at least 1 highly active method and 1 additional effective method of contraception for at least 4 weeks before, during, and for at least 4 weeks after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

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

Endocrine therapy:

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

Radiotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy for uterine LMS and recovered
  • No prior radiotherapy to more than 25% of bone marrow

Surgery:

  • See Disease Characteristics
  • Recovered from recent prior surgery

Other:

  • No prior anticancer therapy that would preclude study therapy
  • At least 3 weeks since other prior therapy for uterine LMS
  • No concurrent bisphosphonates (e.g., zoledronate)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025220

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Community Hospital of Los Gatos
Los Gatos, California, United States, 95032
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
United States, Illinois
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612-3864
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Iowa
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242-1009
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States, 11203
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11794-8091
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1065
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
United States, Ohio
Barrett Cancer Center
Cincinnati, Ohio, United States, 45267-0526
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Ireland Cancer Center
Cleveland, Ohio, United States, 44106
United States, Oklahoma
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States, 73190
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73190
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001-3788
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Tennessee
Brookview Research, Inc.
Nashville, Tennessee, United States, 37203
United States, Texas
CCOP - M.D. Anderson Research Base
Houston, Texas, United States, 77030-4009
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0587
United States, Vermont
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, United States, 05401
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Tacoma General Hospital
Tacoma, Washington, United States, 98405
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6188
Norway
Norwegian Radium Hospital
Oslo, Norway, N-0310
United Kingdom, England
University of Birmingham
Birmingham, England, United Kingdom, B15 2TT
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: D. Scott McMeekin, MD Oklahoma University Cancer Institute
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000068939, GOG-0231-B
Study First Received: October 11, 2001
Last Updated: August 6, 2008
ClinicalTrials.gov Identifier: NCT00025220     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent uterine sarcoma
uterine leiomyosarcoma

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Anti-Infective Agents
Thalidomide
Immunologic Factors
Antineoplastic Agents
Leiomyosarcoma
Physiological Effects of Drugs
Urogenital Neoplasms
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Anti-Bacterial Agents
Neoplasms by Site
Therapeutic Uses
Uterine Neoplasms
Angiogenesis Modulating Agents
Growth Inhibitors
Neoplasms by Histologic Type
Growth Substances
Genital Neoplasms, Female
Uterine Diseases
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Sarcoma
Leprostatic Agents

ClinicalTrials.gov processed this record on November 30, 2009