Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer
A Phase II Study of Sequential Paclitaxel and Bryostatin-1 for Patients With Advanced Pancreatic Cancer
4 other identifiers
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2002
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
March 8, 2002
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
April 21, 2015
CompletedJune 11, 2021
May 1, 2021
8.1 years
March 8, 2002
April 8, 2015
May 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Response Rate of at Least 30%
Number of participants with a Response rate of at least 30%. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).
Up to 8 years
Secondary Outcomes (2)
Number of Participants With Adverse Events
Up to 8 years
Overall Survival
Up to 8 years
Other Outcomes (1)
Bryostatin 1 Pharmacokinetics
Week 1
Study Arms (1)
Treatment (paclitaxel, bryostatin 1)
EXPERIMENTALPatients 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.
Interventions
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montefiore Medical Center
The Bronx, New York, 10467-2490, United States
Related Publications (1)
Lam AP, Sparano JA, Vinciguerra V, Ocean AJ, Christos P, Hochster H, Camacho F, Goel S, Mani S, Kaubisch A. Phase II study of paclitaxel plus the protein kinase C inhibitor bryostatin-1 in advanced pancreatic carcinoma. Am J Clin Oncol. 2010 Apr;33(2):121-4. doi: 10.1097/COC.0b013e3181a31920.
PMID: 19738452RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joseph Sparano
- Organization
- Montefiore Medical Center-New York cancer Consortium
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas Kaubisch
Montefiore Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2002
First Posted
January 27, 2003
Study Start
March 1, 2002
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
June 11, 2021
Results First Posted
April 21, 2015
Record last verified: 2021-05