Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier:
NCT00282087
First received: January 24, 2006
Last updated: January 26, 2012
Last verified: January 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjuvant Treatment of High Risk Uterine Leiomyosarcoma With Gemcitabine/Docetaxel Followed by Doxorubicin: A Phase II Trial

Resource links provided by NLM:


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 ]

Enrollment: 47
Study Start Date: January 2006
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: gemcitabine, docetaxel, doxorubicin
    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
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: 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:
No publications provided by Sarcoma Alliance for Research through Collaboration

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier: NCT00282087     History of Changes
Other Study ID Numbers: SARC005, MSKCC05-128
Study First Received: January 24, 2006
Last Updated: January 26, 2012
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

Additional relevant MeSH terms:
Neoplasms
Leiomyosarcoma
Uterine Neoplasms
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Sarcoma
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Doxorubicin
Liposomal doxorubicin
Gemcitabine
Docetaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 19, 2014