Gemcitabine With Curcumin for Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00192842
First received: September 12, 2005
Last updated: September 21, 2010
Last verified: September 2010
  Purpose

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 Intervention Phase
Pancreatic Cancer
Drug: curcumin (+ gemcitabine)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Gemcitabine and Curcumin in Patients With Advanced Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • time to tumor progression

Secondary Outcome Measures:
  • response rate
  • survival
  • clinical benefit
  • toxicity

Enrollment: 17
Study Start Date: July 2004
Study Completion Date: September 2010
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192842

Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Ron Epelbaum, MD
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00192842     History of Changes
Other Study ID Numbers: RonCurcuminPancreas.CTIL
Study First Received: September 12, 2005
Last Updated: September 21, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
carcinoma
pancreas
gemcitabine
curcumin

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Curcumin
Gemcitabine
Analgesics
Analgesics, Non-Narcotic
Anti-Infective Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Antiviral Agents
Central Nervous System Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Sensory System Agents

ClinicalTrials.gov processed this record on October 23, 2014