Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma
Overview[ - collapse ][ - ]
| 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 | Leiomyosarcoma Uterine Neoplasm |
| Intervention | Drug: gemcitabine, docetaxel, doxorubicin |
| Phase | Phase 2 |
| Sponsor | Sarcoma Alliance for Research through Collaboration |
| 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 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 24, 2006 |
|---|---|
| Last Updated Date | January 26, 2012 |
| Start Date | January 2006 |
| Estimated Primary Completion Date | January 2012 |
| Current 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] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma |
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| Official Title | Adjuvant Treatment of High Risk Uterine Leiomyosarcoma With Gemcitabine/Docetaxel Followed by Doxorubicin: A Phase II Trial |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: gemcitabine, docetaxel, doxorubicin Cycles = 28 days |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 47 |
| Estimated Completion Date | January 2012 |
| Estimated Primary Completion Date | January 2012 |
| 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 |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00282087 |
|---|---|
| Other Study ID Numbers | SARC005 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Sarcoma Alliance for Research through Collaboration |
| Study Sponsor | Sarcoma Alliance for Research through Collaboration |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Martee L. Hensley, MD Memorial Sloan-Kettering Cancer Center |
| Verification Date | January 2012 |
Locations[ + expand ][ + ]
| Washington Cancer Institute/Washington Hospital Center (Medstar) | Washington, District of Columbia, United States, 20010 |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida, United States, 33612 |
| Winship Cancer Institute at Emory University | Atlanta, Georgia, United States, 30308 |
| University of Chicago | Chicago, Illinois, United States, 60637 |
| St. Vincent Gynecologic Oncology | Indianapolis, Indiana, United States, 46260 |
| Dana Farber Cancer Institute | Boston, Massachusetts, United States, 01225 |
| Massachusetts General | Boston, Massachusetts, United States, 02114 |
| University of Michigan | Ann Arbor, Michigan, United States, 48109 |
| Nebraska Methodist Hospital | Omaha, Nebraska, United States, 68114 |
| Memorial Sloan Kettering Cancer Center | New York, New York, United States, 10021 |
| Pennsylvania Oncology Hematology Associates | Philadelphia, Pennsylvania, United States, 19106 |
| MD Anderson Cancer Center | Houston, Texas, United States, 77030 |