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Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00033644
Recruitment Status : Terminated
First Posted : January 27, 2003
Last Update Posted : April 11, 2013
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group

Brief Summary:

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 or disease Intervention/treatment Phase
Sarcoma Biological: sargramostim Drug: cisplatin Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: mitomycin C Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of DMAP Plus GM-CSF in the Treatment of Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
Study Start Date : March 2002
Actual Primary Completion Date : October 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified


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


  • 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


  • Creatinine no greater than 1.5 times ULN


  • 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


Biologic therapy:

  • Not specified


  • 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


  • See Disease Characteristics
  • Recovered from prior recent radiotherapy


  • Recovered from prior recent surgery


  • Recovered from other prior recent therapy
  • No prior cancer treatment that would preclude study therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00033644

Show Show 21 study locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
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Study Chair: Harry J. Long, MD Mayo Clinic
Publications of Results:
Layout table for additonal information Identifier: NCT00033644    
Other Study ID Numbers: CDR0000069308
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: September 2004
Keywords provided by Gynecologic Oncology Group:
stage IV uterine sarcoma
recurrent uterine sarcoma
uterine leiomyosarcoma
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Muscle Tissue
Liposomal doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Alkylating