Carboplatin, Docetaxel, and Radiation Therapy in Treating Patients With Stage III/IV, or Recurrent Endometrial Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin and docetaxel followed by radiation therapy works in treating patients with stage III, stage IV, or recurrent endometrial cancer.

Detailed Description
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OBJECTIVES: Primary Determine the time to progression in patients with stage III or IV or recurrent endometrial cancer treated with induction chemotherapy comprising carboplatin and docetaxel followed by radiotherapy and consolidation chemotherapy comprising carboplatin and docetaxel. Secondary Determine the toxic effects of this regimen in these patients. Determine the overall survival of patients treated with this regimen. OUTLINE: Patients receive docetaxel intravenous (IV) over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses. After hematologic recovery from chemotherapy, patients receive radiotherapy 5 days a week for up to 7 weeks. Beginning 3-4 weeks later, patients receive another 3 courses of docetaxel and carboplatin. After completion of study treatment, patients are followed periodically for 2 years.

Official Title
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A Phase II Trial of Induction Carboplatin and Docetaxel Followed by Radiotherapy Then Consolidation Chemotherapy With Carboplatin and Docetaxel in Stage III, IV and Recurrent Endometrial Cancer

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: docetaxel
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed endometrial cancer Advanced or recurrent disease Stage IIIB or IIIC disease Stage IIIA disease allowed provided there is serosal involvement or direct extension or metastasis to the adnexa No stage IIIA confirmed by only positive peritoneal washings Stage IVA or IVB disease Failed local therapy or considered incurable with local therapy Measurable or evaluable disease Not required for newly diagnosed stage III or IV disease with no remaining disease after surgery Performance status Gynecology Oncology Group (GOG) 0-1 Life expectancy at least 12 weeks Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL Meets 1 of the following criteria: Alkaline phosphatase (AP) normal AND aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 5 times upper limit of normal (ULN) AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN AP ≤ 5 times ULN AND AST or ALT normal Bilirubin normal No acute hepatitis Creatinine ≤ 1.5 mg/dL Exclusion Criteria: Known hypersensitivity to docetaxel or polysorbate 80 Severe infection Septicemia Pregnant or nursing Positive pregnancy test Fertile patients must use effective nonhormonal contraception during and for at least 3 months after study treatment Peripheral neuropathy ≥ grade 2 Severe gastrointestinal bleeding requiring a blood transfusion or hospitalization Other malignancy within the past 5 years except nonmetastatic, nonmelanoma skin cancer or carcinoma in situ of the cervix Prior chemotherapy Prior radiotherapy

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: Patients with Endometrial Cancer<br>Patients with advanced or current endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (Weekly, 5 days/week over 6-7 weeks, tailored 4500 cGy) and followed by 3 courses of consolidation docetaxel (75 mg/m^2 on Day 1 of each course) /carboplatin (Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles). | Drug: carboplatin<br>* Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles.<br>* Other names: Gemzar(R);Drug: docetaxel<br>* 75 mg/m^2 on Day 1 of each course<br>* Other names: Taxotere(R);Radiation: radiation therapy<br>* Weekly, 5 days/week over 6-7 weeks (tailored 4500 cGy)<br>* Other names: radiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients Estimated to be Progression-Free and Alive | This estimate was determined by using a statistical method of analysis (Kaplan-Meier). | 1 Year, 2 Years, 3 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients Estimated to be Alive | This estimate of overall survival was determined by using the statistical method (Kaplan-Meier) of analysis. | 1 Year, 2 Years, 3 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma