Carboplatin, Paclitaxel, and Pegfilgrastim in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, Primary Peritoneal, or Carcinosarcoma Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Fallopian Tube Carcinoma, Infectious Disorder, Neutropenia, Ovarian Carcinosarcoma, Primary Peritoneal Carcinoma, Stage III Ovarian Cancer, Stage IV Ovarian Cancer

Intervention / Treatment
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* Procedure: Adjuvant Therapy
* Drug: Carboplatin
* Drug: Paclitaxel
* Biological: Pegfilgrastim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (carboplatin, paclitaxel, pegfilgrastim)<br>Patients receive carboplatin IV and paclitaxel IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously on day 2. | Procedure: Adjuvant Therapy<br> <br> Drug: Carboplatin<br>* Given IV<br>Drug: Paclitaxel<br>* Given IV<br>* Other names: TAX;Biological: Pegfilgrastim<br>* Given IV<br>* Other names: Neulasta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |