A Phase III Randomized Trial of Gemcitabine plus Docetaxel followed by Doxorubicin v. observation for uterus-limited, High Grade Uterine Leiomyosarcoma

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 216

Inclusion Criteria

- Patients with high risk uterine LMS, 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 is not required.
- Institutional pathology review calls the uterine leiomyosarcoma highgrade.”
- 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 CT of the chest/abdomen/pelvis or by CT chest + MRI abdomen/pelvis. The post-resection imaging studies should be performed within 4 weeks of registration on study.
- Patients must have adequate:
1- Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl (ANC 1.5 x 109/liter (L).
Platelets greater than or equal to100,000/mcl (Platelets 100 x 109/L).
Hemoglobin greater than 8.0 g/dl (= 80 g/L; or 4.9 mmol/L).
2- Renal function: creatinine less than or equal to 1.5 x institutional upper
limit normal (ULN.)
3- Hepatic function: Bilirubin within normal range. SGOT (AST), SGPT (ALT), and 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, Alkaline phosphatase meet the criteria detailed.
4- Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE grade 1.
- Patients with GOG performance status of 0 or 1; ECOG performance status of 0 or,1; or KPS >= 80%.
-Patients who have met the pre-entry requirements specified in Section 7.0.
GOG-0277-7-
- 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 must be a minimum of 18 years of age.
- Patients should be free of active infection requiring antibiotics (with the exception of an uncomplicated UTI).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

- Patients who have had prior therapy with docetaxel or gemcitabine or doxorubicin 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 also 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). ECHO or 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 with a history of prior 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. Documentation of concurrent medications is required.
- Patients with recurrent uterine LMS.
- Patients who are known to be HIV (human immunodeficiency virus) positive are not eligible due to the high risk for infectious complications of the myelsuppressive therapy used in the experimental arm of this study.
GOG-0277-8-
- Patients with gross residual or metastatic tumor findings following complete surgical treatment for uterine LMS.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials