Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent cancer of the uterus. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Collaborator: Gynecologic Oncology Group
• Treatments: Thalidomide

Criteria

Inclusion Criteria:

• 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

• Performance status - GOG 0-2 if received 1 prior therapy regimen

• Performance status - GOG 0-1 if received 2 prior therapy regimens

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• 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

• Creatinine no greater than 1.5 times ULN

• Creatinine clearance greater than 60 mL/min

• 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

• No prior thalidomide

• At least 3 weeks since prior immunologic agents for uterine LMS

• 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

• At least 1 week since prior hormonal therapy for uterine LMS

• Concurrent hormone replacement therapy allowed

• At least 3 weeks since prior radiotherapy for uterine LMS and recovered

• No prior radiotherapy to more than 25% of bone marrow

• Recovered from recent prior surgery

• 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)