search
Back to results

Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

Primary Purpose

Leiomyosarcoma, Uterine Neoplasm

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gemcitabine, docetaxel, doxorubicin
Sponsored by
Sarcoma Alliance for Research through Collaboration
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leiomyosarcoma focused on measuring early stage, high grade, uterine leiomyosarcoma, adjuvant treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Washington Cancer Institute/Washington Hospital Center (Medstar)
  • H. Lee Moffitt Cancer Center and Research Institute
  • Winship Cancer Institute at Emory University
  • University of Chicago
  • St. Vincent Gynecologic Oncology
  • Dana Farber Cancer Institute
  • Massachusetts General
  • University of Michigan
  • Nebraska Methodist Hospital
  • Memorial Sloan Kettering Cancer Center
  • Pennsylvania Oncology Hematology Associates
  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

gemcitabine/docetaxel then doxorubicin

Arm Description

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).

Outcomes

Primary Outcome Measures

Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS

Secondary Outcome Measures

Tolerability/Toxicity of This Regimen
Unacceptable toxicity is defined as grade 3 or 4 non-hematologic toxicity events that are considered to be treatment-related, excluding alopecia and fatigue.
Correlation Between Age and Tumor Response to Treatment (PFS)
Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)
Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS)
AJCC Stage I: No serosal involvement AJCC Stage II: No serosal involement AJCC Stage III: Serosal only
Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)
Mitotic rate is measured in mitoses per 10 high-power fields
Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS)
Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS)
Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS)
Stage I: confined to the uterine corpus Stage II: confined to corpus and cervix Stage IIIA: serosa involvement only (disease could involve the uterine serosa, but patients must have had no other evidence of local spread)
Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS)

Full Information

First Posted
January 24, 2006
Last Updated
November 23, 2014
Sponsor
Sarcoma Alliance for Research through Collaboration
search

1. Study Identification

Unique Protocol Identification Number
NCT00282087
Brief Title
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

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sarcoma Alliance for Research through Collaboration

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyosarcoma, Uterine Neoplasm
Keywords
early stage, high grade, uterine leiomyosarcoma, adjuvant treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gemcitabine/docetaxel then doxorubicin
Arm Type
Other
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
gemcitabine, docetaxel, doxorubicin
Intervention Description
Cycles = 28 days
Primary Outcome Measure Information:
Title
Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS
Time Frame
Every 3 months up to two years
Secondary Outcome Measure Information:
Title
Tolerability/Toxicity of This Regimen
Description
Unacceptable toxicity is defined as grade 3 or 4 non-hematologic toxicity events that are considered to be treatment-related, excluding alopecia and fatigue.
Time Frame
Every 28 days during dosing and then every 3 months thereafter until patient comes off study
Title
Correlation Between Age and Tumor Response to Treatment (PFS)
Time Frame
2 years
Title
Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)
Time Frame
2 years
Title
Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS)
Description
AJCC Stage I: No serosal involvement AJCC Stage II: No serosal involement AJCC Stage III: Serosal only
Time Frame
2 years
Title
Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)
Description
Mitotic rate is measured in mitoses per 10 high-power fields
Time Frame
2 years
Title
Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS)
Time Frame
2 years
Title
Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS)
Time Frame
2 years
Title
Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS)
Description
Stage I: confined to the uterine corpus Stage II: confined to corpus and cervix Stage IIIA: serosa involvement only (disease could involve the uterine serosa, but patients must have had no other evidence of local spread)
Time Frame
2 years
Title
Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS)
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martee L. Hensley, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Cancer Institute/Washington Hospital Center (Medstar)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Winship Cancer Institute at Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
St. Vincent Gynecologic Oncology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
01225
Country
United States
Facility Name
Massachusetts General
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Pennsylvania Oncology Hematology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23335221
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.
Results Reference
derived
Links:
URL
http://www.sarctrials.org
Description
SARC Website

Learn more about this trial

Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

We'll reach out to this number within 24 hrs