Pancreatic CancerPhase 2NCT00192842
Gemcitabine With Curcumin for Pancreatic Cancer
A Phase 2 study testing curcumin (+ gemcitabine) in people with Pancreatic Cancer, run by Rambam Health Care Campus.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- curcumin (+ gemcitabine)
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Sep 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- locally advanced or metastatic adenocarcinoma of the pancreas
- no prior chemotherapy
- performance status 0-2
- adequate hematology and chemistry
Who cannot join
- serious concurrent medical condition
About this study
Official title: Phase II Trial of Gemcitabine and Curcumin in Patients With Advanced Pancreatic Cancer
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.
- Conditions
- Pancreatic Cancer
- Being tested
- curcumin (+ gemcitabine)
- Keywords
- carcinoma, pancreas, gemcitabine, curcumin
- Medical subject headings
- Pancreatic Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcumin (+ gemcitabine)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
time to tumor progression
Secondary outcomes (4)
response rate
survival
clinical benefit
toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionNov 2007
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Ron Epelbaum, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192842
- Sponsor's protocol ID
- RonCurcuminPancreas.CTIL
- Status last verified
- Sep 2010
- First submitted
- 12 Sep 2005
- Last updated
- 22 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Gemcitabine and Curcumin in Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00192842
- Acronym / sponsor ID
- RonCurcuminPancreas.CTIL
- Conditions
- Pancreatic Cancer
- Keywords
- carcinoma, pancreas, gemcitabine, curcumin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- locally advanced or metastatic adenocarcinoma of the pancreas
- no prior chemotherapy
- performance status 0-2
- adequate hematology and chemistry
Key exclusion criteria (1 listed)
- serious concurrent medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| curcumin (+ gemcitabine) | Drug | – |
Primary outcome
time to tumor progression
4 secondary outcomes
response rate
survival
clinical benefit
toxicity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Epelbaum, MD principal investigator
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing curcumin (+ gemcitabine) in people with Pancreatic Cancer, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to tumor progression. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2010.