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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-08

Study Completion Date

2018-08-15

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.

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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.

Conditions

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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 Uterine Carcinosarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (paclitaxel, carboplatin, radiotherapy)

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.

Group Type EXPERIMENTAL

paclitaxel

Intervention Type DRUG

Given IV

carboplatin

Intervention Type DRUG

Given IV

external beam radiation therapy

Intervention Type RADIATION

Undergo external beam radiation therapy

brachytherapy

Intervention Type RADIATION

Undergo HDR brachytherapy

intensity-modulated radiation therapy

Intervention Type RADIATION

Undergo IMRT

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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paclitaxel

Given IV

Intervention Type DRUG

carboplatin

Given IV

Intervention Type DRUG

external beam radiation therapy

Undergo external beam radiation therapy

Intervention Type RADIATION

brachytherapy

Undergo HDR brachytherapy

Intervention Type RADIATION

intensity-modulated radiation therapy

Undergo IMRT

Intervention Type RADIATION

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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Anzatax Asotax Taxol (TAX) Carboplat CBDCA JM-8 Paraplat Paraplatin EBRT low-Linear energy transfer (LET) implant therapy radiation brachytherapy therapy, low-LET implant IMRT

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No