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

Primary Purpose

Esophageal Cancer, Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bryostatin 1
paclitaxel
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Albert Einstein Clinical Cancer Center
  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 2, 2000
Last Updated
June 20, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005599
Brief Title
Bryostatin 1 Plus Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer or Stomach Cancer
Official Title
Phase II Trail of Bryostatin-1 and Paclitaxel in Patients With Advanced Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2004
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Gastric Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bryostatin 1
Intervention Type
Drug
Intervention Name(s)
paclitaxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary K. Schwartz, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Albert Einstein Clinical Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18270704
Citation
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.
Results Reference
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Bryostatin 1 Plus Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer or Stomach Cancer

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