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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Trial of Radiation Therapy Sandwiched Between Paclitaxel and Carboplatin in Patients With Uterine Carcinosarcoma

Conditions
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Uterine Carcinosarcoma, Stage IA Uterine Sarcoma, Stage IB Uterine Sarcoma, Stage IC Uterine Sarcoma, Stage IIA Uterine Sarcoma, Stage IIB Uterine Sarcoma, Stage IIIA Uterine Sarcoma, Stage IIIB Uterine Sarcoma, Stage IIIC Uterine Sarcoma, Stage IVA Uterine Sarcoma, Stage IVB Uterine Sarcoma

Intervention / Treatment
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* Drug: paclitaxel
* Drug: carboplatin
* Radiation: external beam radiation therapy
* Radiation: brachytherapy
* Radiation: intensity-modulated radiation therapy
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (paclitaxel, carboplatin, radiotherapy)<br>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. | Drug: paclitaxel<br>* Given IV<br>* Other names: Taxol (TAX);Drug: carboplatin<br>* Given IV<br>* Other names: Paraplatin;Radiation: external beam radiation therapy<br>* Undergo external beam radiation therapy<br>* Other names: EBRT;Radiation: brachytherapy<br>* Undergo HDR brachytherapy<br>* Other names: therapy, low-LET implant;Radiation: intensity-modulated radiation therapy<br>* Undergo IMRT<br>* Other names: IMRT;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free Survival | One-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution. | Date of entry to date of reappearance of disease, assessed at 1 year |