Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

Gastric Cancer Clinical Trial

Official title:

Phase I Trial of Combined Modality Irinotecan, Cisplatin, and Concurrent Radiation Therapy for Patients With Locally Advanced Esophageal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005638
• Other study ID #: 99-081
• Secondary ID: CDR0000067794NCI
• Status: Completed
• Phase: Phase 1
• First received: May 2, 2000
• Last updated: June 17, 2013
• Start date: October 1999
• Est. completion date: April 2004

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• cisplatin

• irinotecan hydrochloride

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. 200 — View Citation