Phase II Trail of Bryostatin-1 and Paclitaxel in Patients With Advanced Esophageal Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus
or carcinoma of the gastroesophageal (GE) junction

- If tumor extends below GE junction into the proximal stomach, 50% of the tumor
must involve the esophagus or GE junction

- No gastric cancer with only a minor involvement of GE junction or distal
esophagus

- Locally advanced and considered surgically unresectable or metastatic

- Measurable disease

- Accurately measured in at least 1 dimension as at least 20 mm with conventional
techniques or at least 10 mm with spiral CT scan

- No truly nonmeasurable lesions only:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusions

- Inflammatory breast disease

- Lymphangitis cutis/pulmonis

- Abdominal masses not confirmed and followed by imaging techniques

- Cystic lesions

- No brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- Not specified

Hematopoietic:

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 150,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

Renal:

- Creatinine no greater than 1.5 mg/dL

Cardiovascular:

- No history of active angina

- No myocardial infarction within the past 6 months

- No history of significant ventricular arrhythmia requiring medication with
antiarrhythmics

- Well-controlled atrial fibrillation on standard management allowed

Pulmonary:

- DLCO at least 60%

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 2 months after study
participation

- No preexisting neurotoxicity of grade 3 or greater

- No serious concurrent infection or nonmalignant medical illness that is uncontrolled
or whose control may be jeopardized by complications of study therapy

- No concurrent psychiatric disorders that would preclude study compliance

- No other active malignancy within the past 5 years except:

- Nonmelanoma skin cancer

- Carcinoma in situ of the cervix

- History of T1a or b prostate cancer (detected incidentally at transurethral
resection of prostate [TURP] and comprising less than 5% of resected tissue)
provided prostate-specific antigen remained normal since TURP removal

- HIV negative

- No other concurrent medical condition that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent immunotherapy

Chemotherapy:

- Recovered from prior chemotherapy

- No more than 1 prior neoadjuvant or adjuvant regimen for esophageal cancer

- No prior taxanes for esophageal cancer

- No prior bryostatin 1 for esophageal cancer

- No other concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- Prior radiotherapy allowed provided recent evidence of disease progression if
indicator lesion is within prior radiation field

- Recovered from prior radiotherapy

- No concurrent radiotherapy

Surgery:

- Not specified