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:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00352300

First received: July 13, 2006

Last updated: April 23, 2011

Last verified: June 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

July 13, 2006

Last Updated Date

April 23, 2011

Start Date ^ICMJE

June 2006

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Number of patients who have ≥ 1 dose-limiting toxicity during 6 courses of treatment

Change History

Complete list of historical versions of study NCT00352300 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Number of patients with > grade 1 peripheral neuropathy based on the GOG neurotoxicity scale
Frequency and duration of objective response (complete and partial response)
Grade of toxicity as assessed by CTCAE V3.0

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Fallopian Tube Cancer
Infection
Neutropenia
Ovarian Cancer
Primary Peritoneal Cavity Cancer

Intervention ^ICMJE

Biological: pegfilgrastim
Drug: carboplatin
Drug: paclitaxel
Procedure: adjuvant therapy

Study Arm (s)

Publications *

Tiersten AD, Sill MW, Knight D, Muggia F, Garcia AA, Swensen R, Warshal DP, Mannel RS, Fracasso PM. A phase I trial of dose-dense (biweekly) carboplatin combined with paclitaxel and pegfilgrastim: A feasibility study in patients with untreated Stage III and IV ovarian, tubal or primary peritoneal cancer: A Gynecologic Oncology Group study. Gynecol Oncol. 2010 Jun 12; [Epub ahead of print]
Tiersten A, Sill M, Muggia F, et al.: Phase I/feasibility trial of dose-dense carboplatin (C) and paclitaxel (P) in patients (pts) with ovarian cancer: A Gynecologic Oncology Group study. [Abstract] J Clin Oncol 27 (Suppl 15): A-5544, 2009.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00352300

Other Study ID Numbers ^ICMJE

CDR0000486412, GOG-9919

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Gynecologic Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:	Amy D. Tiersten, MD	New York University School of Medicine
Investigator:	Agustin Garcia, MD	Premiere Oncology
Investigator:	Franco M. Muggia, MD	New York University School of Medicine

Information Provided By

National Cancer Institute (NCI)

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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