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

Inclusion Criteria:

• Patients with high-risk uterine leiomyosarcoma (LMS), Federation of Gynecology andObstetrics (FIGO) stage I (confined to corpus +/- cervix); patients with known uterineserosa involvement are not eligible; patients should have had, at least, a completehysterectomy (including removal of the cervix); bilateral salpingo-oophorectomy is notrequired

• Institutional pathology review calls the uterine leiomyosarcoma ?high grade?

• Additionally, if the pathology report indicates a mitotic rate, the mitotic rateshould 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 resectionof cancer at the time of enrollment on study; if a patient requires a secondoperation to complete her surgery, i.e., trachelectomy to remove the cervixand/or bilateral salpingo-oophorectomy (BSO), the 12 weeks may be counted fromthe time of the second operation

• Patients who had a ?morcellation? hysterectomy procedure that involvedmorcellation within the peritoneal cavity are eligible IF a second operation isperformed and biopsies from the second procedure show no evidence ofleiomyosarcoma

• All patients must have no evidence of persistent or metastatic disease as documentedby a post-resection computed tomography (CT) of the chest/abdomen/pelvis or by CTchest + magnetic resonance imaging (MRI) abdomen/pelvis; the post-resection imagingstudies 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/liter [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])* andserum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT])* lessthan 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 totalbilirubin is less than or equal to 1.5 x ULN and the AST, ALT, and alkalinephosphatase meet the criteria detailed

• Neuropathy (sensory and motor) less than or equal to Common Terminology Criteria forAdverse Events (CTCAE) grade 1

• Patients with Gynecologic Oncology Group (GOG) performance status of 0 or 1 OR EasternCooperative Oncology Group (ECOG) PS of 0 or 1 OR Karnofsky performance status (PS) >= 80%

• Patients who have met the pre-entry requirements specified

• Patients must have signed an approved informed consent

• Patients participating through United States (U.S.) sites must sign an approved andauthorization permitting release of personal health information

• Patients should be free of active infection requiring antibiotics (with the exceptionof an uncomplicated urinary tract infection [UTI])

Exclusion Criteria:

• Patients who have had prior therapy with docetaxel, gemcitabine hydrochloride, ordoxorubicin hydrochloride at any time in their history

• Patients with a history of other invasive malignancies, with the exception ofnon-melanoma skin cancer, are ineligible if there is any evidence of other malignancybeing present within the last five years; patients are also ineligible if theirprevious cancer treatment contraindicates this protocol therapy

• Patients with a history of severe hypersensitivity reaction to Taxotere (docetaxel) orother drugs formulated with polysorbate 80

• Patients with GOG performance status of 2, 3 or 4; or ECOG performance status of 2, 3or 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 multigatedacquisition scan (MUGA) is not required prior to enrollment; for patients assigned tothe chemotherapy arm, an ECHO or MUGA should be done within 6 months of day 1 ofgemcitabine-docetaxel treatment

• Patients who enroll on study and are randomized to Regimen I (chemotherapy ) andthen are found on baseline ECHO or MUGA to have cardiac ejection fraction < 50%or below institutional normal will remain ON study; such patients will receivegemcitabine + docetaxel for 4 cycles but will NOT receive any doxorubicintreatment; they will continue treatment follow-up as outlined for all patientsassigned to Regimen I

• Patients with a history of prior whole pelvic radiation

• Concurrent treatment with hormone replacement therapy is permitted at the discretionof the treating physician; patients who have been taking hormonal/hormone blockingagents for breast cancer or breast cancer prevention or other indication are eligible;use of anti-hormonal agents (tamoxifen, medroxyprogesterone, aromatase inhibitors) ispermitted at the discretion of the treating physician; documentation of concurrentmedications is required

• Patients with recurrent uterine LMS

• Patients who are known to be human immunodeficiency virus (HIV) positive are noteligible

• Patients with gross residual or metastatic tumor findings following complete surgicaltreatment for uterine LMS