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: November 23, 2014
Last verified: November 2014
  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: 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:
  • Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS [ Time Frame: Every 3 months up to two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tolerability/Toxicity of This Regimen [ Time Frame: Every 28 days during dosing and then every 3 months thereafter until patient comes off study ] [ Designated as safety issue: Yes ]
    Unacceptable toxicity is defined as grade 3 or 4 non-hematologic toxicity events that are considered to be treatment-related, excluding alopecia and fatigue.

  • Correlation Between Age and Tumor Response to Treatment (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    AJCC Stage I: No serosal involvement AJCC Stage II: No serosal involement AJCC Stage III: Serosal only

  • Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Mitotic rate is measured in mitoses per 10 high-power fields

  • Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Stage I: confined to the uterine corpus Stage II: confined to corpus and cervix Stage IIIA: serosa involvement only (disease could involve the uterine serosa, but patients must have had no other evidence of local spread)

  • Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS) [ Time Frame: 2 years ] [ 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)
Arms Assigned Interventions
gemcitabine/docetaxel then doxorubicin
Gemcitabine 900 mg/m2 IV over 90 minutes days 1 and 8 Docetaxel 75 mg/m2 IV day 8 (pre-medication dexamethasone 4-8 mg p.o. bid for 3 days, starting 12-24 hours prior to docetaxel). Doxorubicin 60 mg/m2 IVP every 21 days for 4 cycles (recommend use of central venous catheter access).
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
Results First Received: July 19, 2013
Last Updated: November 23, 2014
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:
Leiomyosarcoma
Uterine Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Sarcoma
Urogenital Neoplasms
Uterine Diseases
Docetaxel
Doxorubicin
Gemcitabine
Liposomal doxorubicin
Anti-Infective Agents
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 19, 2015