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Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus
This study has been completed.
Sponsors and Collaborators: Gynecologic Oncology Group
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
Drug: cisplatin
Drug: dacarbazine
Drug: doxorubicin hydrochloride
Drug: mitomycin C
Drug: sargramostim
Phase II

MedlinePlus related topics: Cancer Soft Tissue Sarcoma Uterine Cancer
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cisplatin Dacarbazine Sargramostim Granulocyte-macrophage colony-stimulating factor Mitomycin Mitomycins
U.S. FDA Resources
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

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

  Show 21 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Harry J. Long, MD Mayo Clinic
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000069308, GOG-0087K
Study First Received: April 9, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00033644  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Dacarbazine
Leiomyosarcoma
Malignant mesenchymal tumor
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Mitomycins
Recurrence
Soft tissue sarcomas
Doxorubicin
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Cisplatin
Mitomycin
Sarcoma
Uterine Neoplasms
Uterine sarcoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Alkylating
Antibiotics, Antineoplastic
Alkylating Agents
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009