Gemcitabine With Curcumin for Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
curcumin (+ gemcitabine)
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring carcinoma, pancreas, gemcitabine, curcumin
Eligibility Criteria
Inclusion Criteria: locally advanced or metastatic adenocarcinoma of the pancreas no prior chemotherapy performance status 0-2 adequate hematology and chemistry Exclusion Criteria: serious concurrent medical condition
Sites / Locations
Outcomes
Primary Outcome Measures
time to tumor progression
Secondary Outcome Measures
response rate
survival
clinical benefit
toxicity
Full Information
NCT ID
NCT00192842
First Posted
September 12, 2005
Last Updated
September 21, 2010
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT00192842
Brief Title
Gemcitabine With Curcumin for Pancreatic Cancer
Official Title
Phase II Trial of Gemcitabine and Curcumin in Patients With Advanced Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study hypotheasis is that curcumin, a natural compound with a potent antiproliferative effect, can improve the efficacy of the standard chemotherapy gemcitabine in patients with advanced pancreatic cancer. That is why the patients are given a daily oral dose of 8 gr of curcumin along the chemotherapeutic protocol of weekly gemcitabine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
carcinoma, pancreas, gemcitabine, curcumin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
curcumin (+ gemcitabine)
Primary Outcome Measure Information:
Title
time to tumor progression
Secondary Outcome Measure Information:
Title
response rate
Title
survival
Title
clinical benefit
Title
toxicity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
locally advanced or metastatic adenocarcinoma of the pancreas
no prior chemotherapy
performance status 0-2
adequate hematology and chemistry
Exclusion Criteria:
serious concurrent medical condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Epelbaum, MD
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Gemcitabine With Curcumin for Pancreatic Cancer
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