Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer

Study Overview
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Brief Summary
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Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating women who have stage III or stage IV endometrial cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

Detailed Description
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OBJECTIVES: I. Determine the feasibility of doxorubicin and cisplatin followed by whole abdominal radiotherapy in patients with stage III or IV endometrial cancer. II. Determine the acute and chronic toxic effects, in particular, severe and life-threatening gastrointestinal, hepatic, and hematologic toxic effects, of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 21-53 patients will be accrued for this study within 3.5 years.

Official Title
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Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma

Conditions
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Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Stage III Uterine Corpus Cancer, Stage IV Uterine Corpus Cancer

Intervention / Treatment
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* Drug: Doxorubicin Hydrochloride
* Drug: Cisplatin
* Radiation: Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed endometrial cancer including 1 of the following subtypes: Clear cell carcinoma Serous papillary carcinoma Endometrioid adenocarcinoma Stage III or IV disease Positive adnexa Metastases to serosa, bowel mucosa, abdomen Positive pelvic or paraaortic nodes Positive pelvic washings or vaginal involvement within the radiation port Tumor must be surgically reduced to 2 cm or less within 8 weeks of study entry Must have had a hysterectomy and bilateral salpingo oophorectomy No recurrent disease No distant metastases outside of abdominopelvic area, including: Parenchymal liver metastases Lung metastases Positive inguinal lymph nodes Positive supraclavicular nodes Pleural effusion with malignant cytology Performance status - GOG 0-2 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and alkaline phosphatase no greater than 3 times ULN Creatinine no greater than ULN Cardiac ejection fraction greater than 50% No other prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer No prior chemotherapy No prior pelvic or abdominal radiotherapy No prior radiotherapy for other prior malignancy

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 (doxorubicin, cisplatin, radiation therapy)<br>Patients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks. | Drug: Doxorubicin Hydrochloride<br>* Given IV<br>Drug: Cisplatin<br>* Given IV<br>Radiation: Radiation Therapy<br>* Undergo radiation therapy<br>* Other names: RT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients completing the prescribed therapy |  | Up to 9 weeks | 
| Frequency and severity of acute adverse effects as assessed by CTEP CTC version 2.0 |  | 3 weeks | 
| Frequency and severity of chronic adverse effects as assessed by CTEP CTC version 2.0 |  | Up to 5 years after completion of study treatment | 
| Frequency of severe and life threatening bowel, hepatic, and hematologic toxicity as assessed by CTEP CTC version 2.0 |  | Up to 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reason for discontinuing study therapy |  | Up to 9 weeks |