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

Sarcoma Clinical Trial

Official title:

A Phase II Evaluation of DMAP Plus GM-CSF in the Treatment of Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00033644
• Other study ID #: CDR0000069308
• Secondary ID: GOG-0087K
• Status: Terminated
• Phase: Phase 2
• First received: April 9, 2002
• Last updated: April 10, 2013
• Start date: March 2002

Study information

• Verified date: September 2004
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma

Intervention

Biological:
• sargramostim

Drug:
• cisplatin

• dacarbazine

• doxorubicin hydrochloride

• mitomycin C

Locations

Country	Name	City	State
Norway	Norwegian Radium Hospital	Oslo
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland
United States	Tuft-New England Medical Center	Boston	Massachusetts
United States	Cooper University Hospital	Camden	New Jersey
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	Barrett Cancer Center	Cincinnati	Ohio
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	University of Texas Medical Branch	Galveston	Texas
United States	Holden Comprehensive Cancer Center	Iowa City	Iowa
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York
United States	Tacoma General Hospital	Tacoma	Washington
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Norway, 

References & 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. Epub 2005 Jul 26. — View Citation