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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005599
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 21, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

May 2, 2000
January 27, 2003
June 21, 2013
February 2000
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Complete list of historical versions of study NCT00005599 on Archive Site
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Bryostatin 1 Plus Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer or Stomach Cancer
Phase II Trail of Bryostatin-1 and Paclitaxel in Patients With Advanced Esophageal Cancer

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.


  • 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 patients.

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 years.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
  • Esophageal Cancer
  • Gastric Cancer
  • Drug: bryostatin 1
  • Drug: paclitaxel
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Ku GY, Ilson DH, Schwartz LH, Capanu M, O'Reilly E, Shah MA, Kelsen DP, Schwartz GK. Phase II trial of sequential paclitaxel and 1 h infusion of bryostatin-1 in patients with advanced esophageal cancer. Cancer Chemother Pharmacol. 2008 Oct;62(5):875-80. doi: 10.1007/s00280-008-0677-y. Epub 2008 Feb 13.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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August 2004
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  • 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



  • 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 antiarrhythmics
  • 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 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


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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Gary K. Schwartz, MD Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
August 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP