Gemcitabine Hydrochloride, Docetaxel, and Radiation Therapy in Treating Patients With Uterine Sarcoma That Has Been Removed By Surgery

• Status: Terminated
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This pilot clinical trial studies gemcitabine hydrochloride, docetaxel, and radiation therapy in treating patients with uterine sarcoma that has been removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy with radiation therapy may kill any tumor cells that remain after surgery.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein College of Medicine; Albert Einstein College of Medicine of Yeshiva University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel; Gemcitabine

Criteria

Inclusion Criteria:

• Histologically documented uterine leiomyosarcoma with no visible residual disease

• Surgical staging to include total hysterectomy, +/- removal of ovaries and fallopian tubes, +/- lymph node sampling

• Patients must be entered no more than 12 weeks post operatively

• Eastern Cooperative Oncology Group (ECOG) performance status of < 2

• Written voluntary informed consent

Exclusion Criteria:

• Serum glutamic oxaloacetic transaminase (SGOT) and /or serum glutamate pyruvate transaminase (SGPT) > 2.5 times the institutional upper limit of normal

• Total serum bilirubin > 1.5 mg/dl

• History of chronic or active hepatitis

• Serum creatinine > 2.0 mg/dl

• Platelets < 100,000/mm3

• Absolute neutrophil count (ANC) < 1500/mm3

• Hemoglobin < 8.0 g/dl (the patient may be transfused prior to study entry)

• Patients with severe or uncontrolled concurrent medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)

• Patients with any prior chemotherapy or radiotherapy for pelvic malignancy

• Patients who have had prior therapy with gemcitabine or docetaxel

• Patients with known hypersensitivity to gemcitabine or docetaxel

• Patients with known hypersensitivity to pegfilgrastim and filgrastim

• Patients with any history of cancer with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the past five years

• Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry