Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling
Esophageal Cancer, Gastric Cancer

Thank you

Trial Information

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


- 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.

- Determine the toxicity of this regimen in this patient population.

- Determine the survival of patients after treatment with this regimen.

- Determine the quality of life of patients treated with this regimen.

- Examine pre- and post-treatment tissue biopsies for markers of apoptosis in selected

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.

PROJECTED ACCRUAL: A total of 19-33 patients will be accrued for this study within 1-2

Inclusion Criteria


- 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

- 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



- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- Not specified


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

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


- Bilirubin no greater than 1.5 mg/dL


- Creatinine no greater than 1.5 mg/dL


- No history of active angina

- No myocardial infarction within the past 6 months

- No history of significant ventricular arrhythmia requiring medication with

- Well-controlled atrial fibrillation on standard management allowed


- DLCO at least 60%


- Not pregnant or nursing

- Negative pregnancy test

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

- 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


Biologic therapy:

- No concurrent immunotherapy


- 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


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

- Recovered from prior radiotherapy

- No concurrent radiotherapy


- Not specified

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Gary K. Schwartz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

August 2004

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • recurrent gastric cancer
  • stage III esophageal cancer
  • stage IV esophageal cancer
  • recurrent esophageal cancer
  • squamous cell carcinoma of the esophagus
  • adenocarcinoma of the esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Albert Einstein Clinical Cancer Center Bronx, New York  10461