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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00352300
• Other study ID #: GOG-9919
• Secondary ID: NCI-2009-00622CD
• Status: Completed
• Phase: Phase 1
• First received: July 13, 2006
• Last updated: December 29, 2014
• Start date: June 2006

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinosarcoma
• Communicable Diseases
• Fallopian Tube Carcinoma
• Fallopian Tube Neoplasms
• Infection
• Infectious Disorder
• Mixed Tumor, Mullerian
• Neutropenia
• Ovarian Carcinosarcoma
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma
• Stage III Ovarian Cancer
• Stage IV Ovarian Cancer

Intervention

Procedure:
• Adjuvant Therapy

Drug:
• Carboplatin
Given IV
• Paclitaxel
Given IV

Biological:
• Pegfilgrastim
Given IV

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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