Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma - Full Text View

Sponsored by:	Sarcoma Alliance for Research through Collaboration
Information provided by:	Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier:	NCT00282087

Purpose

The purpose of this trial is to study the benefits of giving chemotherapy to women after they have had surgical resection of their primary disease and have no evidence of disease remaining(known as adjuvant therapy). The major objective of this study is to determine the progression free survival. The goal is to prevent relapse or recurrence of their uterine leiomyosarcoma.

Condition	Intervention	Phase
Leiomyosarcoma Uterine Neoplasm	Drug: gemcitabine, docetaxel, doxorubicin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Adjuvant Treatment of High Risk Uterine Leiomyosarcoma With Gemcitabine/Docetaxel Followed by Doxorubicin: A Phase II Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Uterine Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Gemcitabine Myocet Docetaxel Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Sarcoma Alliance for Research through Collaboration:

Primary Outcome Measures:

determine two-year progression-free survival among women treated with this adjuvant regimen for high risk uterine LMS [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

determine tolerability/toxicity of this regimen [ Time Frame: Every 28 days during dosing and then every 3 months therafter ] [ Designated as safety issue: Yes ]
Improve understanding of behavior of uterine LMS through data collection [ Time Frame: Ongoing throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	January 2006
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Cycles = 28 days

Detailed Description:

Patients with a diagnosis of early-stage uterine leiomyosarcoma have a 70% chance of relapse or recurrence of their disease. Patients enrolled in this trial will receive 4 cycles of gemcitabine and docetaxel followed by 4 cycles of adriamycin. Following completion of chemotherapy, they will be have repeat imaging at regular intervals to monitor for disease recurrence along with periodic clinical evaluations.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

≥ 18 years of age
high risk uterine LMS, FIGO stage I or II
pathology review of LMS high grade and /or mitotic rate greater than or equal to 5 mitoses/10 hpf
no longer than 12 weeks from surgical resection of cancer
no evidence of residual disease
ECOG 0 or 1
ANC ≥ 1,500, hemoglobin ≥ 8.0, platelets ≥100,000
creatinine ≤ 1.5 x institutional upper limits of normal
adequate liver function
neuropathy (sensory and motor) ≤ CTC grade 1
negative pregnancy test
signed consent

Exclusion Criteria:

patients with other invasive malignancies
prior therapy with gemcitabine or docetaxel or doxorubicin
hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
women who are breast feeding
cardiac ejection fraction <50%
prior pelvic irradiation
treatment with hormone replacement or anti-hormonal agents or other cytotoxic agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282087

Locations

United States, District of Columbia
Washington Cancer Institute/Washington Hospital Center (Medstar)
Washington, District of Columbia, United States, 20010
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute at Emory University
Atlanta, Georgia, United States, 30308
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
St. Vincent Gynecologic Oncology
Indianapolis, Indiana, United States, 46260
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 01225
Massachusetts General
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, Pennsylvania
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States, 19106
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Sarcoma Alliance for Research through Collaboration

Investigators

Principal Investigator:

Martee L. Hensley, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

SARC Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	SARC ( Denise Reinke, MS, NP, President )
Study ID Numbers:	SARC005, MSKCC05-128
Study First Received:	January 24, 2006
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00282087 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sarcoma Alliance for Research through Collaboration:

early stage
high grade
uterine leiomyosarcoma
adjuvant treatment

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Immunologic Factors
Leiomyosarcoma
Adjuvants, Immunologic
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Immunosuppressive Agents
Antiviral Agents
Doxorubicin

Genital Diseases, Female
Docetaxel
Anti-Bacterial Agents
Neoplasms, Connective and Soft Tissue
Malignant Mesenchymal Tumor
Soft Tissue Sarcomas
Radiation-Sensitizing Agents
Sarcoma
Uterine Neoplasms
Gemcitabine

Additional relevant MeSH terms:

Antimetabolites
Neoplasms, Muscle Tissue
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Leiomyosarcoma
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Antibiotics, Antineoplastic
Genital Diseases, Female
Docetaxel
Neoplasms, Connective and Soft Tissue
Neoplasms by Site

Therapeutic Uses
Uterine Neoplasms
Gemcitabine
Neoplasms by Histologic Type
Genital Neoplasms, Female
Uterine Diseases
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Doxorubicin
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Sarcoma

ClinicalTrials.gov processed this record on September 02, 2009