Carboplatin, Paclitaxel, and Pegfilgrastim in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, Primary Peritoneal, or Carcinosarcoma Cancer
A Phase I Trial of Dose Dense (Biweekly) Carboplatin Combined With Paclitaxel and Pegfilgrastim (Neulasta): A Feasibility Study in Patients With Untreated Stage III and IV Ovarian, Tubal or Primary Peritoneal Cancer
4 other identifiers
interventional
43
1 country
11
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, primary peritoneal, or carcinosarcoma cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving carboplatin and paclitaxel together with pegfilgrastim after surgery may kill any tumor cells that remain after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 13, 2006
CompletedFirst Posted
Study publicly available on registry
July 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedDecember 31, 2014
December 1, 2014
4.1 years
July 13, 2006
December 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients who have greater than or equal to 1 dose-limiting toxicity, assessed by Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
12 weeks
Secondary Outcomes (3)
Number of patients with > grade 1 peripheral neuropathy based on the GOG neurotoxicity scale
Up to 1 year
Frequency and duration of objective response (complete and partial response) assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
Up to 1 year
Grade of toxicity as assessed by CTCAE v3.0
Up to 1 year
Study Arms (1)
Treatment (carboplatin, paclitaxel, pegfilgrastim)
EXPERIMENTALPatients receive carboplatin IV and paclitaxel IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously on day 2.
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (11)
University of California Medical Center At Irvine-Orange Campus
Orange, California, 92868, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
New York University Langone Medical Center
New York, New York, 10016, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Lake University Ireland Cancer Center
Mentor, Ohio, 44060, United States
Cancer Care Associates-Midtown
Tulsa, Oklahoma, 74104, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy Tiersten
Gynecologic Oncology Group
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2006
First Posted
July 14, 2006
Study Start
June 1, 2006
Primary Completion
July 1, 2010
Last Updated
December 31, 2014
Record last verified: 2014-12