Whole-Abdominal Radiation Therapy and Cisplatin in Treating Patients With Stage III or Stage IV Endometrial Cancer That Has Been Removed by Surgery
A Phase I Study Using Abdominal Radiotherapy as a Cisplatin Chemosensitizer for Optimally Debulked Stage III/IV Carcinoma of the Endometrium
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy may also make tumor cells more sensitive to cisplatin. Giving radiation therapy together with cisplatin after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase I trial is studying the side effects and best dose of whole-abdominal radiation therapy when given together with cisplatin in treating patients with stage III or stage IV endometrial cancer that has been removed by surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine a recommended phase II dose of adjuvant whole-abdominal radiotherapy when administered with cisplatin in patients with optimally debulked stage III or IV carcinoma of the endometrium.
OUTLINE: This is a dose-escalation study of whole-abdominal radiotherapy (WAR).
Patients receive 3 courses of standard chemotherapy comprising carboplatin IV and paclitaxel IV. Beginning within 6 weeks after completion of standard chemotherapy, patients receive cisplatin IV over 30-60 minutes and undergo a single fraction of WAR on day 1. Treatment with cisplatin and WAR repeats weekly for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients may undergo standard vaginal brachytherapy beginning no earlier than the last course of standard chemotherapy or no later than 1 week before the start of cisplatin and WAR.
Cohorts of 3-6 patients receive escalating doses of WAR until the recommended phase II dose (RPTD) is determined. The RPTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the RPTD.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Florida
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Miami, Florida, United States, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Diagnosis of endometrial cancer, including any of the following cellular types:
- Papillary serous carcinoma
- Clear cell carcinoma
- Adenocarcinoma
Stage III or IV disease
- No evidence of extra-abdominal extension of disease (e.g., groin nodes, lung, or supraclavicular nodes)
Has undergone total-abdominal hysterectomy, surgical removal of any present fallopian tube and ovary, and resection of any palpable lymph nodes in the pelvis and para-aortic region (or surgical sampling of these nodal regions if no palpable nodes were present) within the past 6 weeks
- Peritoneal washings must have been collected for cytological evaluation
- Must have ≤ 1 cm residual disease after surgery
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Life expectancy ≥ 6 months
- WBC ≥ 3,000/mm^3
- Granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine < 2.0 mg/dL
- Bilirubin < 1.5 times upper limit of normal (ULN)
- Lactate dehydrogenase < 3 times ULN
- Gamma glutamyl transferase < 3 times ULN
- SGPT and SGOT < 3 times ULN
- Alkaline phosphatase < 3 times ULN
- No other malignant tumor within the past 5 years
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy to the whole abdomen and/or pelvis/vagina
- No systemic chemotherapy within the past 5 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Whole-Abdominal Radiation Therapy and Chemotherapy
|
High-Dose Rate [HDR] or Low-Dose Rate [LDR], no earlier than during last cycle of Carboplatin/Taxol chemotherapy; or no later than 1 week before cisplation and WAR therapy
Weekly at 40 mg/m2 (maximum of 70 mg) for 6 weeks, start no later than 6 weeks from last cycle of standard of care carboplatin and taxol chemotherapy
Whole Abdominal Radiation Therapy, Dose Escalated [2-Levels]; 6 -8 hours after administration of Cisplatin chemotherapy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Toxicity as assessed by GOG Common Toxicity Criteria
Time Frame: Study duration
|
Study duration
|
|
Recommended phase II dose of whole-abdominal radiotherapy
Time Frame: Study duration
|
Study duration
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Aaron H. Wolfson, MD, University of Miami Sylvester Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20020138
- SCCC-2001064
- WIRB-20050721
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