Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00005638

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer Gastric Cancer	Drug: cisplatin Drug: irinotecan hydrochloride Radiation: radiation therapy	Phase 1

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 Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 1999

Actual Primary Completion Date :

Apr 1, 2004

Actual Study Completion Date :

Apr 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90033-0804
2	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021