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

This study has been terminated.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00033644
First received: April 9, 2002
Last updated: April 10, 2013
Last verified: September 2004
  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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Study Start Date: March 2002
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
ClinicalTrials.gov Identifier: NCT00033644     History of Changes
Other Study ID Numbers: CDR0000069308, GOG-0087K
Study First Received: April 9, 2002
Last Updated: April 10, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
stage IV uterine sarcoma
recurrent uterine sarcoma
uterine leiomyosarcoma

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

ClinicalTrials.gov processed this record on August 19, 2014