Fallopian Tube Carcinoma, Infectious Disorder, Neutropenia, Ovarian Carcinosarcoma, Primary Peritoneal Carcinoma, Stage III Ovarian Cancer, Stage IV Ovarian Cancer
Conditions
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.
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 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. SECONDARY OBJECTIVES: 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.
Interventions
PROCEDUREAdjuvant Therapy
DRUGCarboplatin
Given IV
DRUGPaclitaxel
Given IV
BIOLOGICALPegfilgrastim
Given IV
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed