Adjuvant Treatment of High Risk Uterine Leiomyosarcoma With Gemcitabine/Docetaxel Followed by Doxorubicin: A Phase II Trial


Phase 2
18 Years
N/A
Not Enrolling
Female
Leiomyosarcoma, Uterine Neoplasm

Thank you

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