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Gemcitabine With Curcumin for Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00192842
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 22, 2010
Sponsor:
Information provided by:
Rambam Health Care Campus

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: curcumin (+ gemcitabine) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Gemcitabine and Curcumin in Patients With Advanced Pancreatic Cancer
Study Start Date : July 2004
Actual Primary Completion Date : November 2007
Actual Study Completion Date : September 2010

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. time to tumor progression

Secondary Outcome Measures :
  1. response rate
  2. survival
  3. clinical benefit
  4. toxicity

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192842


Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Ron Epelbaum, MD
More Information
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ClinicalTrials.gov Identifier: NCT00192842    
Other Study ID Numbers: RonCurcuminPancreas.CTIL
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 22, 2010
Last Verified: September 2010
Keywords provided by Rambam Health Care Campus:
carcinoma
pancreas
gemcitabine
curcumin
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Curcumin
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Enzyme Inhibitors