Full Text View
Tabular View
No Study Results Posted
Related Studies
Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus
This study has been completed.
First Received: April 9, 2002   Last Updated: February 6, 2009   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00033644
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus sargramostim in treating patients who have advanced, persistent, or recurrent cancer of the uterus.


Condition Intervention Phase
Sarcoma
Biological: sargramostim
Drug: cisplatin
Drug: dacarbazine
Drug: doxorubicin hydrochloride
Drug: mitomycin C
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Evaluation of DMAP Plus GM-CSF in the Treatment of Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2002
Detailed Description:

OBJECTIVES:

  • Determine the antitumor activity of dacarbazine, mitomycin, doxorubicin, and cisplatin plus sargramostim (GM-CSF) in patients with advanced, persistent, or recurrent leiomyosarcoma of the uterus.
  • Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: Patients receive dacarbazine IV over 2 hours, followed by mitomycin IV over 2-5 minutes, doxorubicin IV over 2-5 minutes, and cisplatin IV over 2 hours on day 1. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) once every 12 hours on days -6 to -3 before the first chemotherapy course and then on days 2-15 and 23-26 of all chemotherapy courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease receive a maximum of 4 courses. Patients achieving complete or partial response receive a maximum of 6 courses.

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

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

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary leiomyosarcoma (LMS) of the uterus

    • Advanced, persistent, or recurrent disease that is refractory to curative therapy or established treatments
  • At least 1 unidimensionally measurable target lesion

    • At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR
    • At least 10 mm by spiral CT scan
    • Tumors within a previously irradiated field are designated as non-target lesions
  • Ineligible for a higher priority Gynecologic Oncology Group protocol (if one exists), including any active phase III protocol for the same population

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Other:

  • No active infection requiring antibiotics
  • No grade 2 or greater sensory or motor neuropathy
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior cytotoxic chemotherapy for LMS of the uterus

Endocrine therapy:

  • At least 1 week since prior hormonal therapy for LMS of the uterus
  • Concurrent hormone replacement therapy allowed

Radiotherapy:

  • See Disease Characteristics
  • Recovered from prior recent radiotherapy

Surgery:

  • Recovered from prior recent surgery

Other:

  • Recovered from other prior recent therapy
  • No prior cancer treatment that would preclude study therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033644

  Hide Study Locations
Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, Illinois
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612-3864
United States, Iowa
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242-1009
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Massachusetts
Tuft-New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905-0001
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103-1489
United States, New York
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11794-8091
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1065
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
United States, Ohio
Barrett Cancer Center
Cincinnati, Ohio, United States, 45267-0526
United States, Oklahoma
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States, 73190
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001-3788
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0587
United States, Washington
Tacoma General Hospital
Tacoma, Washington, United States, 98405
Norway
Norwegian Radium Hospital
Oslo, Norway, N-0310
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Harry J. Long, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000069308, GOG-0087K
Study First Received: April 9, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00033644     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV uterine sarcoma
recurrent uterine sarcoma
uterine leiomyosarcoma

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Dacarbazine
Molecular Mechanisms of Pharmacological Action
Leiomyosarcoma
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Antibiotics, Antineoplastic
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Cisplatin
Therapeutic Uses
Mitomycin
Uterine Neoplasms
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Genital Neoplasms, Female
Uterine Diseases
Enzyme Inhibitors
Doxorubicin
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Sarcoma
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on November 30, 2009