- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005638
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer
Phase I Trial of Combined Modality Irinotecan, Cisplatin, and Concurrent Radiation Therapy for Patients With Locally Advanced Esophageal Cancer
RATIONALE: 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. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have advanced cancer of the esophagus.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the dose limiting toxicity of irinotecan when given weekly with cisplatin and concurrent external beam multifield radiotherapy in patients with locally advanced carcinoma of the esophagus or gastroesophageal junction.
- Determine the maximum tolerated dose and the recommended phase II dose of irinotecan in this regimen in this patient population.
- Evaluate the complete response rate in these patients to one course of induction chemotherapy followed by concurrent chemotherapy and radiotherapy.
OUTLINE: This is a dose escalation study of irinotecan.
Patients receive induction chemotherapy with cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 15, and 22. Following 2 weeks of rest, patients begin chemoradiation. Patients receive cisplatin and irinotecan as above on days 1, 8, 22, and 29 and radiotherapy once daily 5 days a week for 5-6 weeks.
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
-
-
New York
-
New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction
T1, N1, M0 or T2-4, Nx, M0
- No supraclavicular or celiac lymph nodes
- Previously untreated, newly diagnosed tumors OR
Prior resection without adjuvant therapy with local regional failure
- Positive microscopic margin on resection of all gross disease allowed provided no metastatic disease
- No positive malignant cytology of the pleura, pericardium, or peritoneum
- No biopsy proven tumor invasion of the tracheobronchial tree or tracheoesophageal fistula
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100% OR
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9.0 g/dL
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- No known Gilbert's disease
Renal:
- Creatinine no greater than 1.5 mg/dL
- No hypercalcemia
Cardiovascular:
- No New York Heart Association class III or IV heart disease
- No myocardial infarction within the past 6 months
- No uncontrolled hypertension
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other severe concurrent conditions (e.g., severe uncontrolled diabetes, uncontrolled infections, or cerebral vascular disease)
- No other malignancy within the past 5 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix
- No history of seizure disorder currently receiving phenytoin, phenobarbital, or other antiepileptic medication
- No other concurrent medical or psychiatric condition or disease that would preclude study entry
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for esophageal cancer including adjuvant chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy for esophageal cancer including adjuvant radiotherapy
- No prior mantle, chest, pelvic, or hemibody radiotherapy
Surgery:
- See Disease Characteristics
Other:
- No concurrent prochlorperazine on day of irinotecan administration
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: David H. Ilson, MD, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
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
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Stomach Neoplasms
- Esophageal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Irinotecan
Other Study ID Numbers
- 99-081
- CDR0000067794 (Registry Identifier: PDQ (Physician Data Query))
- NCI-G00-1766
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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