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

DISEASE CHARACTERISTICS:

• 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
• 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
• No patients with recurrent uterine LMS
• No patients with gross residual or metastatic tumor findings following complete surgical treatment for uterine LMS

PATIENT CHARACTERISTICS:

• 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 NOTE: * Patients with a history of Gilbert syndrome may be eligible provided total bilirubin is less than or equal to 1.5 x ULN and AST, ALT, and alkaline phosphatase meet the criteria above.
• 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])
• 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
• No patients with a history of severe hypersensitivity reaction to Taxotere® (docetaxel) or other drugs formulated with polysorbate 80
• No patients who are breast-feeding
• No 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 starting treatment
• Patients who are known to be HIV (human immunodeficiency virus) positive are not eligible

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No patients who have had prior therapy with docetaxel, gemcitabine hydrochloride, or doxorubicin hydrochloride at any time in their history
• No patients with a history of whole pelvic radiation
• Patients are ineligible if their previous cancer treatment contraindicates this protocol therapy
• 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