Phase I Trial of Combined Modality Irinotecan, Cisplatin, and Concurrent Radiation Therapy for Patients With Locally Advanced Esophageal Cancer
18 Years
N/A
Both
Esophageal Cancer, Gastric Cancer
Trial Information
Phase I Trial of Combined Modality Irinotecan, Cisplatin, and Concurrent Radiation Therapy for Patients With Locally Advanced Esophageal Cancer
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
David H. Ilson, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
99-081
NCT ID:
NCT00005638
Start Date:
October 1999
Completion Date:
April 2004
Related Keywords:
- Esophageal Cancer
- Gastric Cancer
- stage II gastric cancer
- stage III gastric cancer
- stage II esophageal cancer
- stage III esophageal cancer
- adenocarcinoma of the stomach
- squamous cell carcinoma of the esophagus
- adenocarcinoma of the esophagus
- Esophageal Diseases
- Esophageal Neoplasms
- Stomach Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
