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Phase II Study of Thalidomide (NSC #66847) in Patients With Sarcomas of Gynecologic Origin


Phase 2
N/A
N/A
Not Enrolling
Female
Endometrial Cancer, Sarcoma

Thank you

Trial Information

Phase II Study of Thalidomide (NSC #66847) in Patients With Sarcomas of Gynecologic Origin


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Scott Wadler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Federal Government

Study ID:

CDR0000068013

NCT ID:

NCT00006005

Start Date:

September 2000

Completion Date:

August 2006

Related Keywords:

  • Endometrial Cancer
  • Sarcoma
  • 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
  • Endometrial Neoplasms
  • Adenoma
  • Sarcoma

Name

Location

Cancer Center of Albany Medical CenterAlbany, New York  12208
Mount Sinai School of MedicineNew York, New York  10029
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
New York Medical CollegeValhalla, New York  10595
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
North Shore University HospitalManhasset, New York  11030
Albert Einstein Clinical Cancer CenterBronx, New York  10461
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
St. Luke's-Roosevelt Hospital Center - Roosevelt DivisionNew York, New York  10019
St. Vincent's Comprehensive Cancer CenterNew York, New York  10011