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

Albert Einstein College of Medicine

Status

Terminated

Conditions

Stage IIIB Uterine Sarcoma

Stage IIB Uterine Sarcoma

Uterine Corpus Leiomyosarcoma

Stage IVB Uterine Sarcoma

Stage IVA Uterine Sarcoma

Stage IIIC Uterine Sarcoma

Stage IIA Uterine Sarcoma

Stage IA Uterine Sarcoma

Stage IIIA Uterine Sarcoma

Stage IC Uterine Sarcoma

Stage IB Uterine Sarcoma

Treatments

Radiation: External Beam Radiation Therapy

Radiation: Intensity-Modulated Radiation Therapy

Radiation: Internal Radiation Therapy

Drug: Gemcitabine Hydrochloride

Drug: Docetaxel

Other: Laboratory Biomarker Analysis

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01958580

13-014

P30CA013330 (U.S. NIH Grant/Contract)

NCI-2013-01364 (Registry Identifier)

13-03-096 (Other Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. To evaluate the toxicity and tolerability of adjuvant pelvic radiation in combination with gemcitabine (gemcitabine hydrochloride)/docetaxel chemotherapy in patients with stage 1 and 2 surgically-resected uterine leiomyosarcoma.

SECONDARY OBJECTIVES:

I. To assess the two year recurrence-free survival in patients with uterine leiomyosarcoma treated with chemotherapy and radiation therapy including defining the patterns of recurrence in patients with uterine leiomyosarcoma who were treated with this regimen.

OUTLINE:

CHEMOTHERAPY: Patients receive gemcitabine hydrochloride intravenously (IV) over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or intensity modulated radiation therapy (IMRT) over 3 weeks. Patients then undergo external beam radiation therapy (EBRT) once daily (QD) 5 days a week for 5 weeks.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

3 participants in 1 patient group

Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)

Experimental group

Description:

CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or IMRT over 3 weeks. Patients then undergo EBRT QD 5 days a week for 5 weeks.