Neutropenia Clinical Trial
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
Verified date | December 2014 |
Source | Gynecologic Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 43 |
Est. completion date | |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Cooper Hospital University Medical Center | Camden | New Jersey |
United States | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio |
United States | Riverside Methodist Hospital | Columbus | Ohio |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | Lake University Ireland Cancer Center | Mentor | Ohio |
United States | New York University Langone Medical Center | New York | New York |
United States | University of California Medical Center At Irvine-Orange Campus | Orange | California |
United States | Women and Infants Hospital | Providence | Rhode Island |
United States | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington |
United States | University of Washington Medical Center | Seattle | Washington |
United States | Cancer Care Associates-Midtown | Tulsa | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Gynecologic Oncology Group | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes | |
Secondary | Number of patients with > grade 1 peripheral neuropathy based on the GOG neurotoxicity scale | Up to 1 year | Yes | |
Secondary | Frequency and duration of objective response (complete and partial response) assessed by Response Evaluation Criteria for Solid Tumors (RECIST) | Up to 1 year | No | |
Secondary | Grade of toxicity as assessed by CTCAE v3.0 | Up to 1 year | Yes |
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