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Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00031694
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : April 21, 2015
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE March 8, 2002
First Posted Date  ICMJE January 27, 2003
Results First Submitted Date  ICMJE April 8, 2015
Results First Posted Date  ICMJE April 21, 2015
Last Update Posted Date April 21, 2015
Study Start Date  ICMJE January 2002
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2015)
Response Rate of at Least 30% [ Time Frame: Up to 8 years ]
Number of participants with a Response rate of at least 30%. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00031694 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2015)
  • Adverse Events [ Time Frame: Up to 8 years ]
    95% confidence intervals will be computed and presented.
  • Overall Survival [ Time Frame: Up to 8 years ]
    Computed using the Kaplan-Meier estimator.
  • Bryostatin 1 Pharmacokinetics [ Time Frame: Week 1 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer
Official Title  ICMJE A Phase II Study of Sequential Paclitaxel and Bryostatin-1 for Patients With Advanced Pancreatic Cancer
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acinar Cell Adenocarcinoma of the Pancreas
  • Duct Cell Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage III Pancreatic Cancer
  • Stage IV Pancreatic Cancer
Intervention  ICMJE
  • Drug: paclitaxel
    Given IV
    Other Names:
    • Anzatax
    • Asotax
    • TAX
    • Taxol
  • Drug: bryostatin 1
    Given IV
    Other Names:
    • B705008K112
    • BRYO
    • Bryostatin
Study Arms  ICMJE Experimental: Treatment (paclitaxel, bryostatin 1)
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.
Interventions:
  • Drug: paclitaxel
  • Drug: bryostatin 1
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2015)
19
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00031694
Other Study ID Numbers  ICMJE NCI-2012-03003
01-09-224 ( Other Identifier: Montefiore Medical Center )
NCI-5624 ( Other Identifier: CTEP )
N01CM17103 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreas Kaubisch Montefiore Medical Center
PRS Account National Cancer Institute (NCI)
Verification Date May 2013

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