Completed

NCT Number: NCT00005840

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paclitaxel

Drug

Given IV

Other names: Anzatax, TAX

Cisplatin

Drug

Given IV

radiation therapy

Radiation

Undergo whole abdominal radiation therapy

Other names: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, RT

Primary outcomes

Acute toxicity for identification of MTD, using the 21 major categories of the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTEP CTC) v2.0

Time frame: 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

Time frame: Up to 6 months post-radiotherapy

Secondary outcomes

Number of dose level combinations that will have been evaluated prior to MTD establishment

Time frame: Up to 60 months
Site (local/distant) of treatment failure

Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

Gynecologic Oncology Group

Network

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start: 2000
Primary completion: 2009
First posted: Jan 27, 2003
Registry last updated: Dec 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed