Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma
This study has been completed.
Sponsor:
Sarcoma Alliance for Research through Collaboration
Information provided by (Responsible Party):
Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier:
NCT00282087
First received: January 24, 2006
Last updated: January 26, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leiomyosarcoma Uterine Neoplasm |
Drug: gemcitabine, docetaxel, doxorubicin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Adjuvant Treatment of High Risk Uterine Leiomyosarcoma With Gemcitabine/Docetaxel Followed by Doxorubicin: A Phase II Trial |
Resource links provided by NLM:
Drug Information available for:
Doxorubicin
Doxorubicin hydrochloride
Gemcitabine
Docetaxel
Gemcitabine hydrochloride
U.S. FDA Resources
Further study details as provided by Sarcoma Alliance for Research through Collaboration:
Primary Outcome Measures:
- determine two-year progression-free survival among women treated with this adjuvant regimen for high risk uterine LMS [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- determine tolerability/toxicity of this regimen [ Time Frame: Every 28 days during dosing and then every 3 months therafter ] [ Designated as safety issue: Yes ]
- Improve understanding of behavior of uterine LMS through data collection [ Time Frame: Ongoing throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 47 |
| Study Start Date: | January 2006 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: gemcitabine, docetaxel, doxorubicin
Cycles = 28 days
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282087
Locations
| United States, District of Columbia | |
| Washington Cancer Institute/Washington Hospital Center (Medstar) | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Winship Cancer Institute at Emory University | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| St. Vincent Gynecologic Oncology | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 01225 | |
| Massachusetts General | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Nebraska | |
| Nebraska Methodist Hospital | |
| Omaha, Nebraska, United States, 68114 | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| United States, Pennsylvania | |
| Pennsylvania Oncology Hematology Associates | |
| Philadelphia, Pennsylvania, United States, 19106 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Sarcoma Alliance for Research through Collaboration
Investigators
| Principal Investigator: | Martee L. Hensley, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided by Sarcoma Alliance for Research through Collaboration
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sarcoma Alliance for Research through Collaboration |
| ClinicalTrials.gov Identifier: | NCT00282087 History of Changes |
| Other Study ID Numbers: | SARC005, MSKCC05-128 |
| Study First Received: | January 24, 2006 |
| Last Updated: | January 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sarcoma Alliance for Research through Collaboration:
|
early stage high grade uterine leiomyosarcoma adjuvant treatment |
Additional relevant MeSH terms:
|
Neoplasms Leiomyosarcoma Uterine Neoplasms Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Sarcoma Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases Genital Diseases, Female Adjuvants, Immunologic Doxorubicin Gemcitabine |
Docetaxel Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on June 17, 2013