Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	MSKCC-99094 MSKCC-FDR001826, NCI-250, NCT00005599, 250

Objectives

1. Determine the complete and partial response rates in patients with unresectable or metastatic esophageal cancer or carcinoma of the gastroesophageal junction treated with sequential paclitaxel and bryostatin 1.
2. Determine the toxicity of this regimen in this patient population.
3. Determine the survival of patients after treatment with this regimen.
4. Determine the quality of life of patients treated with this regimen.
5. Examine pre- and post-treatment tissue biopsies for markers of apoptosis in selected patients.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm³
• Platelet count at least 150,000/mm³

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

Expected Enrollment

A total of 19-33 patients will be accrued for this study within 1-2 years.

Outline

This is a multicenter study.

Patients receive paclitaxel IV over 1 hour on day 1 and bryostatin 1 IV over 24 hours on day 2 weekly for 2 weeks. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

Quality of life is assessed at baseline, after courses 1 and 2, and then after every 2 courses thereafter.

Ku GY, Ilson DH, Schwartz LH, et al.: Phase II trial of sequential paclitaxel and 1 h infusion of bryostatin-1 in patients with advanced esophageal cancer. Cancer Chemother Pharmacol 62 (5): 875-80, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Gary K. Schwartz, MD, Protocol chair		Ph: 212-639-8324; 800-525-2225

Registry Information
Official Title		Phase II Trail of Bryostatin-1 and Paclitaxel in Patients with Advanced Esophageal Cancer
Trial Start Date		2000-02-15
Registered in ClinicalTrials.gov		NCT00005599
Date Submitted to PDQ		2000-03-01
Information Last Verified		2004-08-11
NCI Grant/Contract Number		P30-CA08748, R01-CA67819, U01-CA69913

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