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
  Purpose

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.


Condition Intervention Phase
Endometrial Cancer
Sarcoma
Drug: thalidomide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Thalidomide (NSC #66847) in Patients With Sarcomas of Gynecologic Origin

Resource links provided by NLM:


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

Study Start Date: September 2000
Study Completion Date: August 2006
Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006005

Locations
United States, New York
Cancer Center of Albany Medical Center
Albany, New York, United States, 12208
Albert Einstein Clinical Cancer Center
Bronx, New York, United States, 10461
North Shore University Hospital
Manhasset, New York, United States, 11030
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
Mount Sinai School of Medicine
New York, New York, United States, 10029
St. Luke's-Roosevelt Hospital Center - Roosevelt Division
New York, New York, United States, 10019
St. Vincent's Comprehensive Cancer Center
New York, New York, United States, 10011
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
New York Medical College
Valhalla, New York, United States, 10595
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
New York University Cancer Institute
Investigators
Study Chair: Scott Wadler, MD Weill Medical College of Cornell University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006005     History of Changes
Other Study ID Numbers: CDR0000068013, NYGOG-99-001, NCI-314, NYOG-0102-073
Study First Received: July 5, 2000
Last Updated: June 20, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I uterine sarcoma
stage II uterine sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
recurrent uterine sarcoma
uterine carcinosarcoma
uterine leiomyosarcoma
endometrial stromal sarcoma

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

ClinicalTrials.gov processed this record on July 23, 2014