Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma
Adjuvant Treatment of High Risk Uterine Leiomyosarcoma With Gemcitabine/Docetaxel Followed by Doxorubicin: A Phase II Trial
2 other identifiers
interventional
47
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2006
Longer than P75 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 24, 2006
CompletedFirst Posted
Study publicly available on registry
January 25, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
December 1, 2014
CompletedDecember 1, 2014
November 1, 2014
6 years
January 24, 2006
July 19, 2013
November 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS
Every 3 months up to two years
Secondary Outcomes (9)
Tolerability/Toxicity of This Regimen
Every 28 days during dosing and then every 3 months thereafter until patient comes off study
Correlation Between Age and Tumor Response to Treatment (PFS)
2 years
Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)
2 years
Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS)
2 years
Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)
2 years
- +4 more secondary outcomes
Study Arms (1)
gemcitabine/docetaxel then doxorubicin
OTHERGemcitabine 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).
Interventions
Eligibility Criteria
You may qualify if:
- ≥ 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Washington Cancer Institute/Washington Hospital Center (Medstar)
Washington D.C., District of Columbia, 20010, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Winship Cancer Institute at Emory University
Atlanta, Georgia, 30308, United States
University of Chicago
Chicago, Illinois, 60637, United States
St. Vincent Gynecologic Oncology
Indianapolis, Indiana, 46260, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 01225, United States
Massachusetts General
Boston, Massachusetts, 02114, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, 19106, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Hensley ML, Wathen JK, Maki RG, Araujo DM, Sutton G, Priebat DA, George S, Soslow RA, Baker LH. Adjuvant therapy for high-grade, uterus-limited leiomyosarcoma: results of a phase 2 trial (SARC 005). Cancer. 2013 Apr 15;119(8):1555-61. doi: 10.1002/cncr.27942. Epub 2013 Jan 18.
PMID: 23335221DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Research Project Manager
- Organization
- SARC
Study Officials
- PRINCIPAL INVESTIGATOR
Martee L. Hensley, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2006
First Posted
January 25, 2006
Study Start
January 1, 2006
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
December 1, 2014
Results First Posted
December 1, 2014
Record last verified: 2014-11