Thalidomide in Treating Patients With Gynecologic Sarcomas

New York University Cancer Institute

Status and phase: Completed; Phase 2

Conditions: Endometrial Cancer; Sarcoma

Treatments: Drug: thalidomide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00006005

NCI-314

NYGOG-99-001

NYOG-0102-073

CDR0000068013

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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