NCT00025220CompletedPhase 2
A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
National Cancer Institute (NCI)1 site in 1 country60 target enrollmentStarted: September 2001Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Progression-free survival
Study Overview
Brief 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.
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the antitumor cytostatic activity of thalidomide, as measured by the probability of progression-free survival (PFS) for at least 6 months, in patients with recurrent or persistent uterine leiomyosarcoma.
II. Determine the nature and degree of the toxicity of this drug in these patients.
III. Determine the partial and complete response rates in patients treated with this drug.
IV. Determine the duration of PFS and overall survival of patients treated with this drug.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (thalidomide)
Experimental
Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Intervention: Thalidomide (Drug)
Treatment (thalidomide)
Experimental
Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Intervention: Laboratory Biomarker Analysis (Other)
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 6 months
Frequency and severity of adverse effects as assessed by CTC
Time Frame: Up to 7 years
Secondary Outcomes
- Duration of progression-free survival(Up to 7 years)
- Duration of overall survival(Up to 7 years)
- Frequency of clinical response (partial and complete response)(Up to 7 years)
Investigators
Study Sites (1)
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