Pancreatic NeoplasmsPhase 2NCT00094445
Trial of Curcumin in Advanced Pancreatic Cancer
A Phase 2 study testing Curcumin in people with Pancreatic Neoplasms and Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if treatment with curcumin can help shrink or slow the growth of pancreatic cancers. The effect of curcumin on the way pancreatic cancer cells function and the safety of treatment with curcumin will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms, Adenocarcinoma
- What is being tested?
- Curcumin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Apr 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The patient has pathologically confirmed adenocarcinoma of the pancreas that is not amenable to curative surgical resection (includes locally advanced, metastatic, or recurrent disease). Histology must be confirmed by the pathology department of the investigational center.
- The patient has a Karnofsky Performance Status of greater than or equal to 60 at study entry.
- The patient has given informed consent.
- The patient is at least 18 years of age.
- The patient has adequate hematologic function as defined by an absolute neutrophil count greater than or equal to 1,500/mm3, platelet count greater than or equal to 100,000/mm3.
- The patient has adequate hepatic function as defined by a total bilirubin less than or equal to 2.0 X ULN, alkaline phosphatase, AST and/or ALT less than or equal to 5 X ULN, and creatinine less than or equal to 2.0 mg/dL.
- The patient has measurable disease.
- The patient agrees to use effective contraception if procreative potential exists.
Who cannot join
- The patient has a history of treated or active brain metastases, carcinomatous meningitis, an uncontrolled seizure disorder, or active neurological disease.
- The patient has received prior radiation. Patients with measurable disease outside the radiation port or documented disease progression of previously irradiated measurable disease are eligible. Patient must be greater than or equal to four weeks post-therapy and have recovered from all toxicities.
- The patient has an unstable medical condition according to the investigator, including uncontrolled diabetes mellitus or hypertension; active infections requiring systemic antibiotics, antivirals, or antifungals, unstable CHF, uncontrolled arrythmias, or unstable coagulation disorders.
- The patient is pregnant (confirmed by serum Beta-HCG) or is breast feeding.
- The patient has received an investigational agent(s) within four weeks of study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Curcumin in Patients With Advanced Pancreatic Cancer
The goal of this clinical research study is to learn if treatment with curcumin can help shrink or slow the growth of pancreatic cancers. The effect of curcumin on the way pancreatic cancer cells function and the safety of treatment with curcumin will also be studied.
Read the detailed description
Curcumin, a yellow substance extracted from the plant Curcuma longa, is commonly used as a food additive. It is a natural anti-inflammatory compound and has shown anti-tumor activity in the laboratory. During this study, you will receive much higher doses of curcumin than can be obtained from the diet.
During the study, you will receive curcumin by mouth every day. You will be required to take up to 16 pills per day each morning. Every 8-week period you take curcumin is considered a "course" of treatment. The number of courses you receive depends on how you are responding to treatment. You can continue treatment as long as the disease does not get worse. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
You will be given a questionnaire to complete at the beginning of the study and once a week while you are on therapy to help the medical staff understand how the different symptoms from your disease are affecting you. This questionnaire, which should take about 5 minutes to complete, can be done over the telephone or with the help of one of the study staff during your visits.
At the end of each course of treatment (every 8 weeks), you will have a physical exam and the tumor will be re-evaluated using CT scans and/or blood (about 2 tablespoons) tests.
This is an investigational study. Curcumin is a commercially available substance, which is commonly used as a food additive. Up to 50 participants will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Pancreatic Neoplasms, Adenocarcinoma
- Being tested
- Curcumin
- Keywords
- Pancreatic Cancer, Adenocarcinoma of the pancreas, Alternative therapy, Pancreas, Pancreatic Neoplasm, Cancer of the pancreas
- Medical subject headings
- Pancreatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Also called diferuloyl methane
Starting dose 8 gm orally per day for 8 weeks. If patient experiences grade III toxicity, dose held and restarted with a 50% dose reduction after resolution of toxicity to </= Grade I. Patients with grade IV toxicity will discontinue treatments. Patients with </= grade I toxicity may have a 25% dose increase at each four-week period. Patients will continue on treatment until disease progresses, unless Grade III toxicity supervenes.
| Study group | Role | What they receive |
|---|---|---|
| Curcumin | Experimental | Oral curcumin daily for eight weeks, starting dose 8 gm per day. Receives: Drug: Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-Month Participant Survival
Number of participants followed from baseline (date of randomization) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2004 (estimated)
- Study startNov 2004
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sabinsa Corporation
- Responsible party
- Sponsor
- Investigators
- Vivek Subbiah, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094445
- Sponsor's protocol ID
- ID03-0009
- Other IDs
- 1R21CA104337, NCI-2012-01309
- Status last verified
- Aug 2020
- First submitted
- 18 Oct 2004
- Last updated
- 28 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Aggarwal BB, Kumar A, Bharti AC. Anticancer potential of curcumin: preclinical and clinical studies. Anticancer Res. 2003 Jan-Feb;23(1A):363-98.
PubMed 12680238
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Curcumin in Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00094445
- Acronym / sponsor ID
- ID03-0009
- Conditions
- Pancreatic Neoplasms, Adenocarcinoma
- Keywords
- Pancreatic Cancer, Adenocarcinoma of the pancreas, Alternative therapy, Pancreas, Pancreatic Neoplasm, Cancer of the pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Sabinsa Corporation
- Study start
- Nov 2004
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 Oct 2004 (estimated)
- Results
- Posted 28 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if treatment with curcumin can help shrink or slow the growth of pancreatic cancers. The effect of curcumin on the way pancreatic cancer cells function and the safety of treatment with curcumin will also be studied.
Detailed description
Curcumin, a yellow substance extracted from the plant Curcuma longa, is commonly used as a food additive. It is a natural anti-inflammatory compound and has shown anti-tumor activity in the laboratory. During this study, you will receive much higher doses of curcumin than can be obtained from the diet.
During the study, you will receive curcumin by mouth every day. You will be required to take up to 16 pills per day each morning. Every 8-week period you take curcumin is considered a "course" of treatment. The number of courses you receive depends on how you are responding to treatment. You can continue treatment as long as the disease does not get worse. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
You will be given a questionnaire to complete at the beginning of the study and once a week while you are on therapy to help the medical staff understand how the different symptoms from your disease are affecting you. This questionnaire, which should take about 5 minutes to complete, can be done over the telephone or with the help of one of the study staff during your visits.
At the end of each course of treatment (every 8 weeks), you will have a physical exam and the tumor will be re-evaluated using CT scans and/or blood (about 2 tablespoons) tests.
This is an investigational study. Curcumin is a commercially available substance, which is commonly used as a food additive. Up to 50 participants will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Curcumin | Experimental | Drug: CurcuminOral curcumin daily for eight weeks, starting dose 8 gm per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient has pathologically confirmed adenocarcinoma of the pancreas that is not amenable to curative surgical resection (includes locally advanced, metastatic, or recurrent disease). Histology must be confirmed by the pathology department of the investigational center.
- The patient has a Karnofsky Performance Status of greater than or equal to 60 at study entry.
- The patient has given informed consent.
- The patient is at least 18 years of age.
- The patient has adequate hematologic function as defined by an absolute neutrophil count greater than or equal to 1,500/mm3, platelet count greater than or equal to 100,000/mm3.
Key exclusion criteria (5 listed)
- The patient has a history of treated or active brain metastases, carcinomatous meningitis, an uncontrolled seizure disorder, or active neurological disease.
- The patient has received prior radiation. Patients with measurable disease outside the radiation port or documented disease progression of previously irradiated measurable disease are eligible. Patient must be greater than or equal to four weeks post-therapy and have recovered from all toxicities.
- The patient has an unstable medical condition according to the investigator, including uncontrolled diabetes mellitus or hypertension; active infections requiring systemic antibiotics, antivirals, or antifungals, unstable CHF, uncontrolled arrythmias, or unstable coagulation disorders.
- The patient is pregnant (confirmed by serum Beta-HCG) or is breast feeding.
- The patient has received an investigational agent(s) within four weeks of study entry.
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 |
|---|---|---|
| CurcuminAlso: diferuloyl methaneStarting dose 8 gm orally per day for 8 weeks. If patient experiences grade III toxicity, dose held and restarted with a 50% dose reduction after resolution of toxicity to </= Grade I. Patients with grade IV toxicity will discontinue treatments. Patients with </= grade I toxicity may have a 25% dose increase at each four-week period. Patients will continue on treatment until disease progresses, unless Grade III toxicity supervenes. | Drug | Curcumin |
Primary outcome
Six-Month Participant Survival
Time frame: Baseline to 6 months
Number of participants followed from baseline (date of randomization) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12680238Aggarwal BB, Kumar A, Bharti AC. Anticancer potential of curcumin: preclinical and clinical studies. Anticancer Res. 2003 Jan-Feb;23(1A):363-98.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Vivek Subbiah, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Curcumin in people with Pancreatic Neoplasms and Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
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 8 inclusion and 5 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 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 28 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Six-Month Participant Survival (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00094445, which also lists 1 linked publication.
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 28 Aug 2020.