Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Uterine Cancer

Albert Einstein College of Medicine

Status

Terminated

Conditions

Stage IIB Uterine Sarcoma

Stage IIIB Uterine Sarcoma

Stage IVB Uterine Sarcoma

Stage IIA Uterine Sarcoma

Stage IVA Uterine Sarcoma

Stage IIIC Uterine Sarcoma

Uterine Carcinosarcoma

Stage IA Uterine Sarcoma

Stage IIIA Uterine Sarcoma

Stage IC Uterine Sarcoma

Stage IB Uterine Sarcoma

Treatments

Drug: paclitaxel

Drug: carboplatin

Other: laboratory biomarker analysis

Radiation: intensity-modulated radiation therapy

Radiation: brachytherapy

Radiation: external beam radiation therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01367301

NCI-2013-01225 (Registry Identifier)

10-089 (Other Identifier)

P30CA013330 (U.S. NIH Grant/Contract)

11-02-064 (Other Identifier)

Details and patient eligibility

About

This pilot clinical trial studies radiation therapy, paclitaxel, and carboplatin in treating patients with uterine cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Giving radiation with chemotherapy may kill more tumor cells.

Full description

PRIMARY OBJECTIVES:

I. To assess the one year recurrence-free survival in patients with uterine carcinosarcoma treated with "sandwich" therapy-including defining the patterns of recurrence in patients with carcinosarcoma who were treated with this regimen.

II. To evaluate the toxicity and tolerability of pelvic radiation "sandwiched" between cycles of paclitaxel/carboplatin chemotherapy in patients with uterine carcinosarcoma.

III. To correlate surrogate endpoint biomarkers with progression-free survival and prognosis.

OUTLINE:

CHEMOTHERAPY (weeks 1-9, 14-22): Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 14-22.

RADIATION THERAPY (weeks 8-16): Patients undergo external beam pelvic radiation therapy once a day, 5 days a week for 5 weeks during weeks 8-13. Patients then undergo high dose radiation (HDR) brachytherapy or intensity-modulated radiation therapy (IMRT) once weekly during weeks 14-16.

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

14 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically documented uterine carcinosarcoma with no visible residual disease
Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings
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)
Patient has severe or uncontrolled concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
Patient with any prior chemotherapy or radiotherapy for pelvic malignancy
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)

14 participants in 1 patient group

Treatment (paclitaxel, carboplatin, radiotherapy)

Experimental group

Description:

CHEMOTHERAPY (weeks 1-9, 14-22): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 14-22. RADIATION THERAPY (weeks 8-16): Patients undergo external beam pelvic radiation therapy once a day, 5 days a week for 5 weeks during weeks 8-13. Patients then undergo HDR brachytherapy or IMRT once weekly during weeks 14-16.