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

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00005840

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Clear Cell Adenocarcinoma Endometrial Serous Adenocarcinoma Stage III Uterine Corpus Cancer Stage IV Uterine Corpus Cancer	Drug: Paclitaxel Drug: Cisplatin Radiation: Radiation Therapy	Phase 1

Detailed Description

OBJECTIVES:

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

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I Trial of the Treatment of Advanced Endometrial Cancer With Concurrent Weekly Paclitaxel and Cisplatin and Whole Abdominal Radiation Therapy

Study Start Date :

Jul 1, 2000

Actual Primary Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Paclitaxel Given IV Other Names: Anzatax TAX Drug: Cisplatin Given IV Radiation: Radiation Therapy Undergo whole abdominal radiation therapy Other Names: Cancer Radiotherapy Irradiate Irradiated Irradiation RT

Arm

Intervention/Treatment

Experimental: 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.

Drug: Paclitaxel

Given IV

Other Names:

Anzatax

TAX

Drug: Cisplatin

Given IV

Radiation: Radiation Therapy

Undergo whole abdominal radiation therapy

Other Names:

Cancer Radiotherapy

Irradiate

Irradiated

Irradiation

Outcome Measures

Primary Outcome Measures

Acute toxicity for identification of MTD, using the 21 major categories of the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTEP CTC) v2.0 [Up to 30 days post-radiotherapy]
Calculated using a 90% conditional likelihood-based confidence bound.
Chronic toxicity based on the NCI CTC Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) late radiation morbidity scoring scheme [Up to 6 months post-radiotherapy]

Secondary Outcome Measures

Number of dose level combinations that will have been evaluated prior to MTD establishment [Up to 60 months]
Site (local/distant) of treatment failure [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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