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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

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.

Conditions

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

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 (doxorubicin, cisplatin, radiation therapy)

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.

Group Type EXPERIMENTAL

Doxorubicin Hydrochloride

Intervention Type DRUG

Given IV

Cisplatin

Intervention Type DRUG

Given IV

Radiation Therapy

Intervention Type RADIATION

Undergo radiation therapy

Interventions

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Doxorubicin Hydrochloride

Given IV

Intervention Type DRUG

Cisplatin

Given IV

Intervention Type DRUG

Radiation Therapy

Undergo radiation therapy

Intervention Type RADIATION

Other Intervention Names

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Cancer Radiotherapy Irradiate Irradiated Irradiation RT

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Fowler

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

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Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States