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

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Brief Summary

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This phase I trial is studying the side effects and best dose of combination chemotherapy when given with radiation therapy in treating patients with 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.

Detailed Description

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OBJECTIVES:

I. Determine the safety and maximum tolerated doses of paclitaxel and cisplatin when administered with radiotherapy in patients with stage III or IV endometrial cancer.

II. Assess the time to disease progression and overall survival of patients treated with this regimen.

OUTLINE: This is a dose-escalation study of paclitaxel and cisplatin.

Patients receive paclitaxel IV over 1 hour and cisplatin IV on days 1, 8, 15, 22, 29, and 36. Patients also undergo whole abdominal radiotherapy for 5 consecutive days weekly for 6 weeks.

Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 3-48 patients will be accrued for part I and 14-20 patients will be accrued for part II of this study.

Conditions

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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 (paclitaxel, cisplatin, abdominal radiotherapy)

Patients receive paclitaxel IV over 1 hour and cisplatin IV on days 1, 8, 15, 22, 29, and 36. Patients also undergo whole abdominal radiotherapy for 5 consecutive days weekly for 6 weeks.

Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level.

Group Type EXPERIMENTAL

Paclitaxel

Intervention Type DRUG

Given IV

Cisplatin

Intervention Type DRUG

Given IV

Radiation Therapy

Intervention Type RADIATION

Undergo whole abdominal radiation therapy

Interventions

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Paclitaxel

Given IV

Intervention Type DRUG

Cisplatin

Given IV

Intervention Type DRUG

Radiation Therapy

Undergo whole abdominal radiation therapy

Intervention Type RADIATION

Other Intervention Names

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Anzatax TAX Cancer Radiotherapy Irradiate Irradiated Irradiation RT

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed surgical stage III or IV endometrial cancer
* Any stage clear or serous papillary endometrial cancer
* Positive para-aortic lymph nodes allowed
* Tumor must be surgically reduced to 2 cm or less within 8 weeks of study

* Must have had hysterectomy and bilateral salpingo-oophorectomy
* No recurrent disease
* No metastases to lung or liver parenchyma or inguinal or scalene lymph nodes
* Performance status - GOG 0-2
* Absolute neutrophil count greater than 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT no greater than 3 times ULN
* Creatinine no greater than 1.5 times ULN
* No other prior or concurrent malignancy in the past 5 years except non-melanoma skin cancer
* No prior chemotherapy
* No prior radiotherapy
* See Disease Characteristics
* No more than 8 weeks since prior surgery
* No prior anticancer therapy that would preclude study

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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D. McMeekin

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