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Iowa City, Iowa 52242

  • Sarcoma

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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000069308


NCT ID:

NCT00033644


Secondary ID:

GOG-0087K


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Gynecologic Oncology Group


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Harry J. Long, MD
Study Chair
Mayo Clinic

Study Dates

Start Date:March 2002
Primary Completion Date:October 2005
Primary Completion Type:Actual
Verification Date:September 2004
Last Changed Date:April 10, 2013
First Received Date:April 9, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:sargramostim
Intervention Type:Drug
Name:cisplatin
Intervention Type:Drug
Name:dacarbazine
Intervention Type:Drug
Name:doxorubicin hydrochloride
Intervention Type:Drug
Name:mitomycin C

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Gynecologic Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:16051328

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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