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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00352300
First received: July 13, 2006
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

RATIONALE: 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.

PURPOSE: 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.


Condition Intervention Phase
Fallopian Tube Cancer
Infection
Neutropenia
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Biological: pegfilgrastim
Drug: carboplatin
Drug: paclitaxel
Procedure: adjuvant therapy
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Number of patients who have ≥ 1 dose-limiting toxicity during 6 courses of treatment [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of patients with > grade 1 peripheral neuropathy based on the GOG neurotoxicity scale [ Designated as safety issue: Yes ]
  • Frequency and duration of objective response (complete and partial response) [ Designated as safety issue: No ]
  • Grade of toxicity as assessed by CTCAE V3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: June 2006
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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

  • Estimate the percentage of patients who develop ≥ grade 2 peripheral neurotoxicity from this regimen.
  • Estimate the clinical response rate in patients with measurable disease treated with this regimen.
  • 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.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radiotherapy or chemotherapy
  • No prior cancer treatment that would contraindicate study treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352300

Locations
United States, California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, New York
NYU Cancer Institute at New York University 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, 43210-1240
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
Cancer Care Associates - Saint Francis Campus
Tulsa, Oklahoma, United States, 74136-1929
United States, Rhode Island
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Amy D. Tiersten, MD New York University School of Medicine
Study Chair: Agustin Garcia, MD Premiere Oncology
Study Chair: Franco M. Muggia, MD New York University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00352300     History of Changes
Other Study ID Numbers: GOG-9919, CDR0000486412, NCI-2009-00622
Study First Received: July 13, 2006
Last Updated: August 19, 2013
Health Authority: United States: Federal Government
United States: National Cancer Institute

Keywords provided by Gynecologic Oncology Group:
infection
neutropenia
primary peritoneal cavity cancer
fallopian tube cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
ovarian carcinosarcoma

Additional relevant MeSH terms:
Carcinosarcoma
Fallopian Tube Neoplasms
Infection
Neutropenia
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Agranulocytosis
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Hematologic Diseases
Leukocyte Disorders
Leukopenia
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplasms, Connective and Soft Tissue
Ovarian Diseases
Peritoneal Diseases
Sarcoma
Urogenital Neoplasms
Carboplatin

ClinicalTrials.gov processed this record on October 21, 2014