Phase II Single-Arm Trial Of CPT-11 (Irinotecan HC1; Camptosar Injection)/Cisplatin In Patients With Advanced Esophageal Cancer
Inclusion 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