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

NCT00033644 | Terminated Phase 2

• 2 other identifiers: CDR0000069308GOG-0087K
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 21

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.

Conditions

Sarcoma

Keywords

stage IV uterine sarcoma; recurrent uterine sarcoma; uterine leiomyosarcoma

Interventions

sargramostim BIOLOGICAL

cisplatin DRUG

dacarbazine DRUG

doxorubicin hydrochloride DRUG

mitomycin C DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (21)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80010, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5001, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612-3864, United States

Location

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242-1009, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Tuft-New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905-0001, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103-1489, United States

Location

State University of New York Health Sciences Center - Stony Brook

Stony Brook, New York, 11794-8091, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1065, United States

Location

Barrett Cancer Center

Cincinnati, Ohio, 45267-0526, United States

Location

University of Oklahoma College of Medicine

Oklahoma City, Oklahoma, 73190, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001-3788, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0587, United States

Location

Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Related Publications (1)

• Long HJ 3rd, Blessing JA, Sorosky J. Phase II trial of dacarbazine, mitomycin, doxorubicin, and cisplatin with sargramostim in uterine leiomyosarcoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2005 Nov;99(2):339-42. doi: 10.1016/j.ygyno.2005.06.002. Epub 2005 Jul 26.

  PMID: 16051328 RESULT

MeSH Terms

Conditions

Sarcoma

Interventions

sargramostim; Cisplatin; Dacarbazine; Doxorubicin; Mitomycin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Mitomycins; Indolequinones; Quinones; Azirines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Harry J. Long, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: April 9, 2002
• First Posted: January 27, 2003
• Study Start: March 1, 2002
• Primary Completion: October 1, 2005
• Last Updated: April 11, 2013

Record last verified: 2004-09

Locations

NO (1); US (20)