Phase I Trial of the Treatment of Advanced Endometrial Cancer With Concurrent Weekly Paclitaxel and Cisplatin and Whole Abdominal Radiation Therapy
Paclitaxel
+ Cisplatin
+ Radiation Therapy
Treatment Study
Summary
Study start date: July 1, 2000
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.35 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location