Clinical trial NCT00282087: Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma
Official title: Adjuvant Treatment of High Risk Uterine Leiomyosarcoma With Gemcitabine/Docetaxel Followed by Doxorubicin: A Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leiomyosarcoma
Uterine Neoplasm
Keywords: early stage
high grade
uterine leiomyosarcoma
adjuvant treatment
Lead sponsor: Sarcoma Alliance for Research through Collaboration
Sponsor class: OTHER
First posted: 2006-01-25
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS
timeFrame: Every 3 months up to two years
Secondary outcomes:
measure: Tolerability/Toxicity of This Regimen
timeFrame: Every 28 days during dosing and then every 3 months thereafter until patient comes off study
measure: Correlation Between Age and Tumor Response to Treatment (PFS)
timeFrame: 2 years
measure: Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)
timeFrame: 2 years
measure: Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS)
timeFrame: 2 years
measure: Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)
timeFrame: 2 years
measure: Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS)
timeFrame: 2 years
measure: Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS)
timeFrame: 2 years
measure: Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS)
timeFrame: 2 years
measure: Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Cancer Institute/Washington Hospital Center (Medstar)
state: District of Columbia
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute at Emory University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Gynecologic Oncology
state: Indiana
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Pennsylvania Oncology Hematology Associates
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Martee L. Hensley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.