Carboplatin, Paclitaxel, and Pegfilgrastim in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, Primary Peritoneal, or Carcinosarcoma Cancer
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|ClinicalTrials.gov Identifier: NCT00352300|
Recruitment Status : Completed
First Posted : July 14, 2006
Last Update Posted : December 31, 2014
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Carcinoma Infectious Disorder Neutropenia Ovarian Carcinosarcoma Primary Peritoneal Carcinoma Stage III Ovarian Cancer Stage IV Ovarian Cancer||Procedure: Adjuvant Therapy Drug: Carboplatin Drug: Paclitaxel Biological: Pegfilgrastim||Phase 1|
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 major dose delays or additional hematological support (e.g., red blood cell or platelet transfusions or admission for febrile neutropenia), in patients with stage III-IV ovarian epithelial, fallopian tube, primary peritoneal cancer, or carcinosarcoma cancer.
I. Estimate the percentage of patients who develop ≥ grade 2 peripheral neurotoxicity from this regimen.
II. Estimate the clinical response rate in patients with measurable disease treated with this regimen.
III. Assess the toxicity of this regimen.
OUTLINE: This is a multicenter study.
Patients receive carboplatin IV and paclitaxel IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||July 2010|
Experimental: Treatment (carboplatin, paclitaxel, pegfilgrastim)
Patients receive carboplatin IV and paclitaxel IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously on day 2.
Procedure: Adjuvant Therapy
Given IVDrug: Paclitaxel
Other Names:Biological: Pegfilgrastim
- 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) [ Time Frame: 12 weeks ]
- Number of patients with > grade 1 peripheral neuropathy based on the GOG neurotoxicity scale [ Time Frame: Up to 1 year ]
- Frequency and duration of objective response (complete and partial response) assessed by Response Evaluation Criteria for Solid Tumors (RECIST) [ Time Frame: Up to 1 year ]
- Grade of toxicity as assessed by CTCAE v3.0 [ Time Frame: Up to 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00352300
|United States, California|
|University of California Medical Center At Irvine-Orange Campus|
|Orange, California, United States, 92868|
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|United States, New Jersey|
|Cooper Hospital University Medical Center|
|Camden, New Jersey, United States, 08103|
|United States, New York|
|New York University Langone Medical Center|
|New York, New York, United States, 10016|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Riverside Methodist Hospital|
|Columbus, Ohio, United States, 43214|
|Lake University Ireland Cancer Center|
|Mentor, Ohio, United States, 44060|
|United States, Oklahoma|
|Cancer Care Associates-Midtown|
|Tulsa, Oklahoma, United States, 74104|
|United States, Rhode Island|
|Women and Infants Hospital|
|Providence, Rhode Island, United States, 02905|
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|University of Washington Medical Center|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Amy Tiersten||Gynecologic Oncology Group|