Status:
COMPLETED
Carboplatin, Paclitaxel, and Pegfilgrastim in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, Primary Peritoneal, or Carcinosarcoma Cancer
Lead Sponsor:
Gynecologic Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Fallopian Tube Carcinoma
Infectious Disorder
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects of giving carboplatin and paclitaxel together with pegfilgrastim in treating patients with stage III or stage IV ovarian epithelial, fallopian tube, pri...
Detailed Description
PRIMARY OBJECTIVES: I. Establish the feasibility of adjuvant dose-dense carboplatin and paclitaxel followed by pegfilgrastim, in terms of absence of grade 3 or 4 nonhematologic toxicities without maj...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Diagnosis of 1 of the following:
- Primary peritoneal carcinoma
- Fallopian tube carcinoma
- Ovarian epithelial carcinoma
- Carcinosarcoma
- Stage III or IV disease
- Previously untreated disease, except for mandatory prior surgery
- No ovarian epithelial carcinoma of low malignant potential (i.e., borderline carcinomas)
- GOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9.0 g/dL
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- SGOT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- No peripheral neuropathy (sensory or motor) ≥ grade 2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other invasive malignancies within the past 5 years except nonmelanoma skin cancer
- No septicemia, severe infection, or acute hepatitis
- No prior radiotherapy or chemotherapy
- No prior cancer treatment that would contraindicate study treatment
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00352300
Start Date
June 1 2006
Last Update
December 31 2014
Active Locations (11)
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1
University of California Medical Center At Irvine-Orange Campus
Orange, California, United States, 92868
2
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
3
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
4
New York University Langone Medical Center
New York, New York, United States, 10016