Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery

Status: Recruiting
Phase: Phase 3
Diagnosis: Sarcoma
NCT ID: NCT01533207 (View complete trial on
DFCI Protocol ID: 14-015


This randomized phase III trial studies how well gemcitabine hydrochloride and docetaxel followed by doxorubicin hydrochloride work compared to observation in treating patients with high-risk uterine leiomyosarcoma previously removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, docetaxel, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether combination therapy after surgery is an effective treatment for uterine leiomyosarcoma.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Suzanne George, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Emily Leonard,
Dana-Farber Cancer Institute: Melissa Hohos,

Eligibility Criteria

Inclusion Criteria: - Patients with high-risk uterine leiomyosarcoma (LMS), International Federation of Gynecology and Obstetrics (FIGO) stage I (confined to corpus +/- cervix); patients with known uterine serosa involvement are not eligible; patients should have had, at least, a complete hysterectomy (including removal of the cervix); bilateral salpingo-oophorectomy (BSO) is not required - Institutional pathology review calls the uterine leiomyosarcoma "high grade" - Additionally, if the pathology report indicates a mitotic rate, the mitotic rate should be greater than or equal to 5 mitoses/10 high-power field - All patients must be no longer than 12 weeks (3 months) from surgical resection of cancer at the time of enrollment on study; if a patient requires a second operation to complete her surgery, i.e., trachelectomy to remove the cervix and/or BSO, the 12 weeks may be counted from the time of the second operation - Patients who had a "morcellation" hysterectomy procedure that involved morcellation within the peritoneal cavity are eligible IF a second operation is performed and biopsies from the second procedure show no evidence of leiomyosarcoma - All patients must have no evidence of persistent or metastatic disease as documented by a post-resection computed tomography (CT) of the chest/abdomen/pelvis or by CT chest + magnetic resonance imaging (MRI) abdomen/pelvis; the post-resection imaging studies should be performed within 4 weeks of registration on study - Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL (ANC >= 1.5 x 10^9/L) - Platelets greater than or equal to 100,000/mcL (platelets >= 100 x 10^9/L) - Hemoglobin greater than 8.0 g/dL (= 80 g/L or 4.9 mmol/L) - Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN) - Bilirubin* within normal range - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST])* and serum glutamic pyruvate transaminase(SGPT) (alanine aminotransferase [ALT])* less than or equal to 2.5 times ULN - Alkaline phosphatase* less than or equal to 2.5 x ULN - * Patients with a history of Gilbert's syndrome may be eligible provided total bilirubin is less than or equal to 1.5 x ULN and the AST, ALT, and alkaline phosphatase meet the criteria detailed - Neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events(CTCAE) grade 1 - Patients with Gynecologic Oncology Group (GOG) performance status (PS) of 0 or 1 OR Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 OR Karnofsky PS >= 80% - Patients must have signed an approved informed consent - Patients participating through U.S. sites must sign an approved and authorization permitting release of personal health information - Patients should be free of active infection requiring antibiotics (with the exception of an uncomplicated urinary tract infection [UTI]) Exclusion Criteria: - Patients who have had prior therapy with docetaxel, gemcitabine hydrochloride, or doxorubicin hydrochloride at any time in their history - Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are ineligible if there is any evidence of other malignancy being present within the last five years - Patients are ineligible if their previous cancer treatment contraindicates this protocol therapy - Patients with a history of severe hypersensitivity reaction to Taxotere (docetaxel) or other drugs formulated with polysorbate 80 - Patients with GOG performance status of 2, 3 or 4; or ECOG performance status of 2, 3 or 4 - Patients who are breast-feeding - Patients with a known history of congestive heart failure or cardiac ejection fraction < 50% (or less than institutional normal limits); echocardiogram (ECHO) or multigated acquisition scan (MUGA) is not required prior to enrollment; for patients assigned to the chemotherapy arm, an ECHO or MUGA should be done within 6 months of day 1 of gemcitabine-docetaxel treatment - Patients who enroll on study and are randomized to Regimen I (chemotherapy ) and then are found on baseline ECHO or MUGA to have cardiac ejection fraction < 50% or below institutional normal will remain ON study; such patients will receive gemcitabine + docetaxel for 4 cycles but will NOT receive any doxorubicin treatment; they will continue treatment follow-up as outlined for all patients assigned to Regimen I - Patients with a history of whole pelvic radiation - Concurrent treatment with hormone replacement therapy is permitted at the discretion of the treating physician; patients who have been taking hormonal/hormone-blocking agents for breast cancer or breast cancer prevention or other indication are eligible; use of anti-hormonal agents (tamoxifen, medroxyprogesterone, aromatase inhibitors) is permitted at the discretion of the treating physician - Patients with recurrent uterine LMS - Patients who are known to be human immunodeficiency virus (HIV) positive are not eligible - Patients with gross residual or metastatic tumor findings following complete surgical treatment for uterine LMS
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