Thalidomide in Treating Patients With Gynecologic Sarcomas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2006-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Endometrial Cancer Sarcoma

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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thalidomide

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No