Adjuvant Treatment of High Risk Uterine Leiomyosarcoma With Gemcitabine/Docetaxel Followed by Doxorubicin: A Phase II Trial
18 Years
N/A
Female
Leiomyosarcoma, Uterine Neoplasm
Trial Information
Adjuvant Treatment of High Risk Uterine Leiomyosarcoma With Gemcitabine/Docetaxel Followed by Doxorubicin: A Phase II Trial
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
determine two-year progression-free survival among women treated with this adjuvant regimen for high risk uterine LMS
Outcome Time Frame:
Every 3 months
Safety Issue:
Yes
Principal Investigator
Martee L. Hensley, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
SARC005
NCT ID:
NCT00282087
Start Date:
January 2006
Completion Date:
January 2012
Related Keywords:
- Leiomyosarcoma
- Uterine Neoplasm
- early stage
- high grade
- uterine leiomyosarcoma
- adjuvant treatment
- Neoplasms
- Leiomyosarcoma
- Uterine Neoplasms
Name | Location |
|---|---|
| University of Michigan | Ann Arbor, Michigan 48109-0624 |
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| Pennsylvania Oncology Hematology Associates | Philadelphia, Pennsylvania 19107 |
| Nebraska Methodist Hospital | Omaha, Nebraska 68114 |
| Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| University of Chicago | Chicago, Illinois 60637 |
| St. Vincent Gynecologic Oncology | Indianapolis, Indiana 46260 |
| Winship Cancer Institute at Emory University | Atlanta, Georgia 30322 |
| Washington Cancer Institute/Washington Hospital Center (Medstar) | Washington, District of Columbia 20010 |
| Massachusetts General | Boston, Massachusetts 02114 |
