Expired Study
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New Britain, Connecticut 06050


Purpose:

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating patients with persistent or recurrent stage III or stage IV uterine cancer.


Study summary:

OBJECTIVES: - Determine the antitumor activity of paclitaxel and carboplatin in patients with persistent or recurrent stage III or IV uterine carcinosarcoma. - Determine the nature and degree of toxicity of this regimen in these patients. OUTLINE: This is a non-randomized, multicenter study. Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: Approximately 14-47 patients will be accrued for this study within 20 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed uterine carcinosarcoma (mixed mesodermal tumor) - Stage III or IV disease - Persistent or recurrent disease - Documented disease progression - Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan - At least 1 target lesion - Tumors within a previously irradiated field are not considered target lesions unless there is documented disease progression - Ineligible for any higher priority Gynecology Oncology Group (GOG) protocol (i.e., any active GOG phase III protocol for the same patient population) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - GOG 0-2 Life expectancy - Not specified Hematopoietic - Platelet count ≥ 100,000/mm^3 - Absolute neutrophil count ≥ 1,500/mm^3 Hepatic - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - SGOT ≤ 2.5 times ULN - Alkaline phosphatase ≤ 2.5 times ULN Renal - Creatinine ≤ 1.5 times ULN Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active infection requiring antibiotics - No other invasive malignancy within the past 5 years except nonmelanoma skin cancer - No sensory or motor neuropathy > grade 1 PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior cytotoxic chemotherapy for uterine sarcoma Endocrine therapy - At least 1 week since prior hormonal therapy for uterine sarcoma - Concurrent hormone replacement therapy allowed Radiotherapy - See Disease Characteristics Surgery - Not specified Other - Recovered from all prior therapy - No prior anticancer therapy that would preclude study therapy


NCT ID:

NCT00112489


Primary Contact:

Study Chair
Matthew A. Powell, MD
Washington University Siteman Cancer Center


Backup Contact:

N/A


Location Contact:

New Britain, Connecticut 06050
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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