A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NSC# 123127) v. Observation for Uterus-Limited, High Grade Uterine Leiomyosarcoma

Inclusion Criteria

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