Esophageal Cancer Clinical Trial

Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining irinotecan and cisplatin in treating patients who have locally advanced unresectable or metastatic cancer of the esophagus that has not been previously treated.

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Full Description

OBJECTIVES:

Determine the objective tumor response rate in patients with previously untreated locally advanced unresectable or metastatic esophageal cancer treated with irinotecan and cisplatin.
Determine the dysphagia relief in patients treated with this regimen.
Determine the time to progression and overall survival of patients treated with this regimen.
Determine the safety of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive cisplatin IV over 1-2 hours and irinotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus

Previously untreated
Locally advanced unresectable or metastatic disease
More than 50% of tumor must involve esophagus or gastroesophageal (GE) junction if tumor extends below the GE junction into the proximal stomach

At least 1 unidimensionally measurable lesion

At least 20 mm by conventional techniques OR
At least 10 mm by spiral CT scan

The following are not considered measurable disease:

Bone lesions
Leptomeningeal disease
Ascites
Pleural/pericardial effusions
Lymphangitis cutis/pulmonis
Abdominal masses not confirmed and followed by imaging techniques
Cystic lesions
Tumor lesions in previously irradiated areas

No carcinomatous meningitis or untreated brain metastases

Brain metastases allowed if asymptomatic and patient is on stable or tapering dose of steroids

Large pleural effusions must have been previously drained and sclerosed or otherwise controlled

Small, stable, asymptomatic pleural effusions allowed
Dysphagia allowed

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2 OR
Karnofsky 60-100%

Life expectancy:

At least 3 months

Hematopoietic:

Absolute neutrophil count at least 1,500/mm^3
WBC at least 3,000/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than 1.5 mg/dL
AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
No known Gilbert's disease

Renal:

Creatinine no greater than 1.5 mg/dL
Calcium less than 12.0 mg/dL

Cardiovascular:

No history of significant cardiovascular disease
No inadequately controlled hypertension
No unstable angina
No myocardial infarction within the past 6 months
No ventricular cardiac arrhythmias requiring medication
No history or treatment for congestive heart failure

Pulmonary:

No interstitial pneumonia
No fibroid lung

Other:

No serious active infection
No uncontrolled diabetes mellitus (random blood sugar at least 300 mg)
No peripheral neuropathy grade 2 or greater
No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other malignancy that does not carry a worse prognosis than advanced esophageal cancer
No other serious underlying medical condition that would preclude study
No other concurrent disease that would preclude study
No psychiatric illness or other significant mental impairment that would preclude study
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy

Endocrine therapy:

See Disease Characteristics

Radiotherapy:

See Disease Characteristics
At least 2 weeks since prior radiotherapy and recovered
No prior radiotherapy to the pelvis

Surgery:

See Disease Characteristics
Not specified

Other:

No concurrent phenytoin or phenobarbital

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Study ID:

NCT00030862

Recruitment Status:

Completed

Sponsor:

Memorial Sloan Kettering Cancer Center

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There is 1 Location for this study

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Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Study ID:

NCT00030862

Recruitment Status:

Completed

Sponsor:


Memorial Sloan Kettering Cancer Center

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