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Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

NCT ID: NCT00282087

Last Updated: 2014-12-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2012-01-31

Brief Summary

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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

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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.

Conditions

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Leiomyosarcoma Uterine Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type OTHER

gemcitabine, docetaxel, doxorubicin

Intervention Type DRUG

Cycles = 28 days

Interventions

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gemcitabine, docetaxel, doxorubicin

Cycles = 28 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sarcoma Alliance for Research through Collaboration

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martee L. Hensley, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Washington Cancer Institute/Washington Hospital Center (Medstar)

Washington D.C., District of Columbia, United States

Site Status

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Winship Cancer Institute at Emory University

Atlanta, Georgia, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

St. Vincent Gynecologic Oncology

Indianapolis, Indiana, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Massachusetts General

Boston, Massachusetts, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Pennsylvania Oncology Hematology Associates

Philadelphia, Pennsylvania, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23335221 (View on PubMed)

Related Links

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http://www.sarctrials.org

SARC Website

Other Identifiers

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MSKCC05-128

Identifier Type: OTHER

Identifier Source: secondary_id

SARC005

Identifier Type: -

Identifier Source: org_study_id