Brief Summary
Phase II trial to study the effectiveness of combining paclitaxel and bryostatin-1 in treating patients who have locally advanced unresectable or metastatic pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin-1 may help paclitaxel kill more cancer cells by making tumor cells more sensitive to the drug.
Brief Title
Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the response rates to weekly, sequential paclitaxel/ bryostatin-1 in patients with unresectable and metastatic pancreatic cancer.
II. To determine the toxicity of therapy. III. To determine patient survival after therapy. IV. To determine Bryostatin-1 pharmacokinetics.
OUTLINE: This is an open-label, multicenter study.
Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
I. To determine the response rates to weekly, sequential paclitaxel/ bryostatin-1 in patients with unresectable and metastatic pancreatic cancer.
II. To determine the toxicity of therapy. III. To determine patient survival after therapy. IV. To determine Bryostatin-1 pharmacokinetics.
OUTLINE: This is an open-label, multicenter study.
Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Acinar Cell Adenocarcinoma of the Pancreas
Duct Cell Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
* Histologic proof of adenocarcinoma of the pancreas that is locally advanced and considered surgically not resectable or metastatic
* Patients with or without prior treatment are eligible for treatment on protocol; prior treatment may have included one treatment course of chemo/RT and/ or one course of chemotherapy, but not two prior courses of chemotherapy;
* Measurable disease
* ECOG performance status of 0-1
* Ability to sign an informed consent form indicating awareness of the investigational nature of this study, in keeping with the policies of the hospital
* Patients may not be receiving any other concurrent chemotherapy, immunotherapy, or radiotherapy; the most recent treatment for pancreatic cancer, within the limitations of allowed prior therapy must be 28 days or longer prior to enrollment on study
* Absolute granulocytes \> 1,500/mm\^3
* Platelets \> 150,000/mm\^3
* Serum bilirubin \< 1.5 mg/dl
* Serum creatinine \< 1.5 mg/dl
Exclusion Criteria:
* Presence of any ongoing toxic effect from prior treatment
* Brain metastases
* History of active angina or myocardial infarction within 6 months; history of significant ventricular arrhythmia requiring medication with antiarrhythmics; well controlled atrial fibrillation on standard management will be permitted
* Pregnant or lactating women
* Pre-existing neurotoxicity that is graded 3+ or greater
* Serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy
* Psychiatric disorders rendering patients incapable of complying with the requirements of the protocol
* HIV infection
* Any other medical condition or reason that, in the investigator's opinion, makes the patient unsuitable to participate in a clinical trial (for example a history of prior poor compliance with treatment)
* Histologic proof of adenocarcinoma of the pancreas that is locally advanced and considered surgically not resectable or metastatic
* Patients with or without prior treatment are eligible for treatment on protocol; prior treatment may have included one treatment course of chemo/RT and/ or one course of chemotherapy, but not two prior courses of chemotherapy;
* Measurable disease
* ECOG performance status of 0-1
* Ability to sign an informed consent form indicating awareness of the investigational nature of this study, in keeping with the policies of the hospital
* Patients may not be receiving any other concurrent chemotherapy, immunotherapy, or radiotherapy; the most recent treatment for pancreatic cancer, within the limitations of allowed prior therapy must be 28 days or longer prior to enrollment on study
* Absolute granulocytes \> 1,500/mm\^3
* Platelets \> 150,000/mm\^3
* Serum bilirubin \< 1.5 mg/dl
* Serum creatinine \< 1.5 mg/dl
Exclusion Criteria:
* Presence of any ongoing toxic effect from prior treatment
* Brain metastases
* History of active angina or myocardial infarction within 6 months; history of significant ventricular arrhythmia requiring medication with antiarrhythmics; well controlled atrial fibrillation on standard management will be permitted
* Pregnant or lactating women
* Pre-existing neurotoxicity that is graded 3+ or greater
* Serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy
* Psychiatric disorders rendering patients incapable of complying with the requirements of the protocol
* HIV infection
* Any other medical condition or reason that, in the investigator's opinion, makes the patient unsuitable to participate in a clinical trial (for example a history of prior poor compliance with treatment)
Inclusion Criteria
Inclusion Criteria:
* Histologic proof of adenocarcinoma of the pancreas that is locally advanced and considered surgically not resectable or metastatic
* Patients with or without prior treatment are eligible for treatment on protocol; prior treatment may have included one treatment course of chemo/RT and/ or one course of chemotherapy, but not two prior courses of chemotherapy;
* Measurable disease
* ECOG performance status of 0-1
* Ability to sign an informed consent form indicating awareness of the investigational nature of this study, in keeping with the policies of the hospital
* Patients may not be receiving any other concurrent chemotherapy, immunotherapy, or radiotherapy; the most recent treatment for pancreatic cancer, within the limitations of allowed prior therapy must be 28 days or longer prior to enrollment on study
* Absolute granulocytes \> 1,500/mm\^3
* Platelets \> 150,000/mm\^3
* Serum bilirubin \< 1.5 mg/dl
* Serum creatinine \< 1.5 mg/dl
* Histologic proof of adenocarcinoma of the pancreas that is locally advanced and considered surgically not resectable or metastatic
* Patients with or without prior treatment are eligible for treatment on protocol; prior treatment may have included one treatment course of chemo/RT and/ or one course of chemotherapy, but not two prior courses of chemotherapy;
* Measurable disease
* ECOG performance status of 0-1
* Ability to sign an informed consent form indicating awareness of the investigational nature of this study, in keeping with the policies of the hospital
* Patients may not be receiving any other concurrent chemotherapy, immunotherapy, or radiotherapy; the most recent treatment for pancreatic cancer, within the limitations of allowed prior therapy must be 28 days or longer prior to enrollment on study
* Absolute granulocytes \> 1,500/mm\^3
* Platelets \> 150,000/mm\^3
* Serum bilirubin \< 1.5 mg/dl
* Serum creatinine \< 1.5 mg/dl
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
19 Years
NCT Id
NCT00031694
Org Class
Nih
Org Full Name
National Cancer Institute (NCI)
Org Study Id
NCI-2012-03003
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase II Study of Sequential Paclitaxel and Bryostatin-1 for Patients With Advanced Pancreatic Cancer
Primary Outcomes
Outcome Description
Number of participants with a Response rate of at least 30%. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).
Outcome Measure
Response Rate of at Least 30%
Outcome Time Frame
Up to 8 years
Secondary Ids
Secondary Id
01-09-224
Secondary Id
NCI-5624
Secondary Id
N01CM17103
Secondary Outcomes
Outcome Time Frame
Up to 8 years
Outcome Measure
Number of Participants With Adverse Events
Outcome Description
Computed using the Kaplan-Meier estimator.
Outcome Time Frame
Up to 8 years
Outcome Measure
Overall Survival
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
19
Investigators
Investigator Type
Principal Investigator
Investigator Name
Andreas Kaubisch
Investigator Email
akaubisc@montefiore.org
Investigator Phone
718-920-7100