Status:
COMPLETED
Paclitaxel and Carboplatin in Treating Patients With Persistent or Recurrent Stage III or Stage IV Uterine Cancer
Lead Sponsor:
Gynecologic Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Sarcoma
Eligibility:
FEMALE
18-120 years
Phase:
PHASE2
Brief Summary
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. Givi...
Detailed Description
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 toxi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00112489
Start Date
May 1 2005
Last Update
September 25 2018
Active Locations (110)
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1
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
2
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
3
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States, 06050
4
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958