Adjuvant Docetaxel Plus Gemcitabine in Patients With Completely Resected Leiomyosarcoma (LMS) of the Uterus

December 21, 2015 updated by: Memorial Sloan Kettering Cancer Center

A Pilot Study of Adjuvant Docetaxel Plus Gemcitabine in Patients With Completely Resected Leiomyosarcoma (LMS) of the Uterus

This is a pilot study of adjuvant therapy for patients with leiomyosarcoma of the uterus that has been completely removed by surgery. "Adjuvant" therapy means that the tumor (the leiomyosarcoma) has been completely removed by surgery; thus, giving further treatment now is done in hopes of decreasing the chance that the tumor will come back (relapse or recur). The main goal of this study is to show that this series of treatments is safe for patients with your type of tumor.

In this trial you will be getting drugs that have been approved for use in some types of cancer. In this study we wish to see whether the combination of two chemotherapy drugs, docetaxel and gemcitabine can decrease the chance of your tumor, leiomyosarcoma of the uterus, from coming back (relapsing). We will also be looking at the short-term side effects and risks of the drugs given in this combination to patients with leiomyosarcoma that has been completely resected (removed by surgery).

The combination of gemcitabine and docetaxel has been shown to be safe, and it has been shown to decrease the size of leiomyosarcoma tumors in patients with leiomyosarcoma of the uterus that has relapsed, or has continued to grow despite treatment with other chemotherapy drugs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pathologically confirmed leiomyosarcoma of the uterus, completely resected, stage I, II, III or IV within 8 weeks of surgery to remove the tumor(s). Patients with stage I tumors should have LMS that is considered high-grade by histology.
  • No prior chemotherapy for LMS
  • No prior treatment with gemcitabine or docetaxel Age > 18 years
  • Karnofsky performance status (KPS) > or equal to 80%
  • Pre-treatment absolute neutrophil count > or equal to 1500/ul, hemoglobin greater than or equal to 8.0 gm/dl, and platelets > than or equal to 100,000/ul.
  • Adequate renal documented by serum creatinine < than or equal to 2.0 mg/dL
  • Adequate hepatic function: Total serum bilirubin must be within institutional normal limits; transaminases (ALT and AST) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is < than or equal to ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are < than or equal to ULN.

If peripheral neuropathy is present, it must be less than or equal to grade 1

  • Capable of providing written, informed consent
  • Women with child-bearing potential must have a negative pregnancy test and must consent to using effective contraception while on treatment and for a reasonable period there after.

Exclusion Criteria:

  • Active, or uncontrolled infection
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than 3 years prior to registration, and the patient remains free of recurrent or metastatic disease.
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 3 years prior to registration, and that the patient remains free of recurrent or metastatic disease.
  • With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 3 years or whose previous cancer treatment contraindicates this protocol therapy are excluded.
  • Known history of hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80, or history of hypersensitivity reaction to gemcitabine.
  • Currently has grade 2, 3 or 4 neuropathy
  • Pregnant or lactating women
  • Known history of congestive heart failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 patients with completely resected uterine leiomyosarcoma
Docetaxel plus Gemcitabine
Drug: Docetaxel plus Gemcitabine
Gemcitabine 900 mg/m2 IV over 90 minutes day 1 Gemcitabine 900 mg/m2 IV over 90 minutes day 8 + Docetaxel 75 mg/m2 IVPB day 8 Dexamethasone 8 mg po bid days 7-9 GCSF 150 ug/m2 (round to nearest vial size: 350 ug or 480 ug) SQ days 9-15 Repeat every 21 days for total of 4 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the tolerability of delivering 4 cycles of docetaxel plus gemcitabine.
Time Frame: conclusion of the study
conclusion of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine the percentage of pts with completely resected uterine LMS tx with the regimen that remain progression-free at 2 years, & compare this rate with historical controls to establish an estimate of the efficacy of the adjuvant treatment strategy.
Time Frame: conclusion of the study
conclusion of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Martee Hensley, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

January 31, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Estimate)

December 22, 2015

Last Update Submitted That Met QC Criteria

December 21, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-098

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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