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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

Primary Purpose

Esophageal Cancer, Gastric Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cisplatin
irinotecan hydrochloride
radiation therapy
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC/Norris Comprehensive Cancer Center and Hospital
  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 2, 2000
Last Updated
June 17, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005638
Brief Title
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer
Official Title
Phase I Trial of Combined Modality Irinotecan, Cisplatin, and Concurrent Radiation Therapy for Patients With Locally Advanced Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Gastric Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H. Ilson, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12885811
Citation
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.
Results Reference
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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

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