Docetaxel, Gemcitabine, and Filgrastim (G-CSF) or Pegfilgrastim in Treating Patients With Advanced, Persistent, or Recurrent Uterine Leiomyosarcoma

February 12, 2014 updated by: Gynecologic Oncology Group

A Phase II Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus

RATIONALE: Drugs used in chemotherapy, such as docetaxel and gemcitabine, 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 G-CSF and 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 docetaxel and gemcitabine together with G-CSF or pegfilgrastim may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel and gemcitabine together with G-CSF or pegfilgrastim works in treating patients with advanced, persistent, or recurrent uterine leiomyosarcoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the antitumor activity of docetaxel, gemcitabine, and filgrastim (G-CSF) or pegfilgrastim in patients with advanced, persistent, or recurrent uterine leiomyosarcoma.
  • Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior pelvic radiotherapy (yes vs no).

Patients receive gemcitabine IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 9-15 OR pegfilgrastim SC on day 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 12-43 patients will be accrued for this study within 12-28 months.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Medical Center - Los Angeles
    • Connecticut
      • Hartford, Connecticut, United States, 06102-5037
        • Helen and Harry Gray Cancer Center at Hartford Hospital
      • New Britain, Connecticut, United States, 06050
        • New Britain General Hospital
    • Delaware
      • Newark, Delaware, United States, 19713
        • CCOP - Christiana Care Health Services
    • Georgia
      • Augusta, Georgia, United States, 30912
        • MBCCOP-Medical College of Georgia Cancer Center
      • Macon, Georgia, United States, 31208
        • Medical Center of Central Georgia
      • Savannah, Georgia, United States, 31403-3089
        • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Illinois
      • Aurora, Illinois, United States, 60507
        • Rush-Copley Cancer Care Center
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
      • Hinsdale, Illinois, United States, 60521
        • Hinsdale Hematology Oncology Associates
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology Associates, Limited - West
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Michigan City, Indiana, United States, 46360
        • Saint Anthony Memorial Health Centers
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Holden Comprehensive Cancer Center at University of Iowa
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70815
        • Woman's Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4505
        • University of Mississippi Medical Center
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
      • Springfield, Missouri, United States, 65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, United States, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, United States, 65807
        • Hulston Cancer Center at Cox Medical Center South
      • St Louis, Missouri, United States, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Methodist Cancer Center at Methodist Hospital - Omaha
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Fox Chase Virtua Health Cancer Program - Marlton
      • Newark, New Jersey, United States, 07103
        • UMDNJ University Hospital
      • Voorhees, New Jersey, United States, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
      • Voorhees, New Jersey, United States, 08043
        • Fox Chase Virtua Health Cancer Program at Virtua West Jersey
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-5636
        • University of New Mexico Cancer Research and Treatment Center
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology, PC at Albany Regional Cancer Care
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Medical Center
      • Stony Brook, New York, United States, 11794-8174
        • Stony Brook University Cancer Center
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Hope A Women's Cancer Center
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Regional Cancer Center at Forsyth Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Charles M. Barrett Cancer Center at University Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, United States, 44106
        • Case Comprehensive Cancer Center
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic Cancer Center at Fairview Hospital
      • Columbus, Ohio, United States, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Dayton, Ohio, United States, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Mentor, Ohio, United States, 44060
        • Lake/University Ireland Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Medical Center
      • Tulsa, Oklahoma, United States, 74104
        • Cancer Care Associates - Midtown Tulsa
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Rosenfeld Cancer Center at Abington Memorial Hospital
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine - Center City Hahnemann Campus
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital of Rhode Island
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center at Medical University of South Carolina
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Centers for Cancer Care
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed uterine leiomyosarcoma

    • Advanced, persistent, or recurrent disease
    • Documented disease progression

  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

  • At least 1 target lesion

    • Tumors within a previously irradiated field are considered nontarget lesions
  • Ineligible for higher priority GOG protocols (i.e., any active phase III GOG protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age

  • Adult

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No neuropathy (sensory or motor) > grade 1
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No active infection requiring antibiotics
  • No known hypersensitivity to E. coli-derived proteins

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior cytotoxic chemotherapy for the malignancy

Endocrine therapy

  • At least 1 week since prior hormonal therapy for the malignancy
  • Concurrent hormone replacement therapy allowed

Radiotherapy

  • See Disease Characteristics
  • Recovered from prior radiotherapy

Surgery

  • Recovered from prior surgery

Other

  • Recovered from all other prior therapy
  • No prior cancer treatment that would preclude study treatment
  • No concurrent amifostine or other protective agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Toxicity
Antitumor activity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Martee L. Hensley, MD, Memorial Sloan Kettering Cancer Center
  • Gregory P. Sutton, MD, St. Vincent Gynecologic Oncology at St. Vincent Oncology Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

January 7, 2005

First Submitted That Met QC Criteria

January 7, 2005

First Posted (Estimate)

January 10, 2005

Study Record Updates

Last Update Posted (Estimate)

February 14, 2014

Last Update Submitted That Met QC Criteria

February 12, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOG-0087L
  • CDR0000405892

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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