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NCT00192842 Clinical Trial

Gemcitabine With Curcumin for Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:
Phase II Trial of Gemcitabine and Curcumin in Patients With Advanced Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00192842
Other study ID # RonCurcuminPancreas.CTIL
Secondary ID
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated September 21, 2010
Start date July 2004
Est. completion date September 2010

Study information
Verified date September 2010
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date September 2010
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• curcumin (+ gemcitabine)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Outcome
Type Measure Description Time frame Safety issue
Primary time to tumor progression
Secondary response rate
Secondary survival
Secondary clinical benefit
Secondary toxicity
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