Bryostatin 1 Plus Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer or Stomach Cancer

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

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 bryostatin 1 and paclitaxel in treating patients who have locally advanced or metastatic esophageal cancer or stomach cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Bryostatin 1; Paclitaxel

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