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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000067794 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-G00-1766 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| irinotecan hydrochloride | Drug | |||
| radiation therapy | Radiation |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction
T1, N1, M0 or T2-4, Nx, M0
Previously untreated, newly diagnosed tumors OR
Prior resection without adjuvant therapy with local regional failure
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:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| David H. Ilson, MD, PhD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | 90033-0804 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12885811 | Result | Ilson DH, Bains M, Kelsen DP, O'Reilly E, Karpeh M, Coit D, Rusch V, Gonen M, Wilson K, Minsky BD. Phase I trial of escalating-dose irinotecan given weekly with cisplatin and concurrent radiotherapy in locally advanced esophageal cancer. J Clin Oncol. 2003 Aug 1;21(15):2926-32. doi: 10.1200/JCO.2003.02.147. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| C562730 | Adenocarcinoma Of Esophagus |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000077146 | Irinotecan |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Memorial Sloan-Kettering Cancer Center |
| New York |
| New York |
| 10021 |
| United States |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D002166 |
| Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |