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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005599
First received: May 2, 2000
Last updated: June 20, 2013
Last verified: August 2004

May 2, 2000
June 20, 2013
February 2000
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Complete list of historical versions of study NCT00005599 on ClinicalTrials.gov 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.

OBJECTIVES:

  • 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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
  • Esophageal Cancer
  • Gastric Cancer
  • Drug: bryostatin 1
  • Drug: paclitaxel
Not Provided
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. Epub 2008 Feb 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
August 2004
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005599
CDR0000067712, MSKCC-99094, MSKCC-FDR001826, NCI-250
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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