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

Primary Purpose

Fallopian Tube Carcinoma, Infectious Disorder, Neutropenia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Adjuvant Therapy
Carboplatin
Paclitaxel
Pegfilgrastim
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of California Medical Center At Irvine-Orange Campus
  • University of Iowa Hospitals and Clinics
  • Cooper Hospital University Medical Center
  • New York University Langone Medical Center
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
  • Riverside Methodist Hospital
  • Lake University Ireland Cancer Center
  • Cancer Care Associates-Midtown
  • Women and Infants Hospital
  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  • University of Washington Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (carboplatin, paclitaxel, pegfilgrastim)

Arm Description

Patients receive carboplatin IV and paclitaxel IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously on day 2.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Number of patients with > grade 1 peripheral neuropathy based on the GOG neurotoxicity scale
Frequency and duration of objective response (complete and partial response) assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
Grade of toxicity as assessed by CTCAE v3.0

Full Information

First Posted
July 13, 2006
Last Updated
December 29, 2014
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00352300
Brief Title
Carboplatin, Paclitaxel, and Pegfilgrastim in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, Primary Peritoneal, or Carcinosarcoma Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Carcinoma, Infectious Disorder, Neutropenia, Ovarian Carcinosarcoma, Primary Peritoneal Carcinoma, Stage III Ovarian Cancer, Stage IV Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (carboplatin, paclitaxel, pegfilgrastim)
Arm Type
Experimental
Arm Description
Patients receive carboplatin IV and paclitaxel IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously on day 2.
Intervention Type
Procedure
Intervention Name(s)
Adjuvant Therapy
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Anzatax, TAX
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Pegfilgrastim
Other Intervention Name(s)
Filgrastim SD-01, GCSF-SD01, Neulasta
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Number of patients with > grade 1 peripheral neuropathy based on the GOG neurotoxicity scale
Time Frame
Up to 1 year
Title
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
Title
Grade of toxicity as assessed by CTCAE v3.0
Time Frame
Up to 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Tiersten
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Medical Center At Irvine-Orange Campus
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Cooper Hospital University Medical Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Lake University Ireland Cancer Center
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Cancer Care Associates-Midtown
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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