Pancreatic CancerPhase 2NCT00176813
Gemcitabine, Cisplatin, and Celecoxib Treatment of Metastatic Pancreatic Cancer
A Phase 2 study testing Gemcitabine, Cisplatin and Celecoxib in people with Pancreatic Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This study will examine an investigational (experimental) treatment using gemcitabine, cisplatin, and celecoxib. Preliminary studies have shown that this experimental treatment may be effective in reducing the size of cancerous tumors and/or preventing further tumor growth. 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?
- Gemcitabine, Cisplatin and Celecoxib
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Nov 2006
- 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
- Patients must have histologic or cytologic diagnosis of pancreatic adenocarcinoma.
- Patients must have clinical/radiologic evidence of metastatic disease (stage IV).
- Patients must not have received prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy is allowed, provided that the last day of therapy was at least 6 months prior to starting treatment.
- Patients must have performance status of 0-2 on the SWOG scale.
- Patients must have an estimated life expectancy of at least 12 weeks.
- Patients must have adequate bone marrow function: absolute neutrophil count >1,500/cmm, platelet count >100,000/cmm.
- Patients must be informed of the investigational nature of this study and must give written informed consent prior to the receiving of treatment per this protocol.
- Patients must practice effective birth control while receiving treatment.
Who cannot join
- Patients with endocrine tumors or lymphoma of the pancreas.
- Patients with locally advanced pancreatic cancer.
- Patients with a proven history (radiographic and/or endoscopic) of peptic ulcer or esophageal erosions within one year of enrollment onto the study.
- Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs.
- History of active central nervous system (CNS) metastases.
- Inadequate liver function (bilirubin >3.0 mg/dL); transaminases (AST/ALT) >3 times upper limit of institutional normal.
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- Inadequate renal function (creatinine >1.5 mg/dL).
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
- History of other malignancy, except for cancers that have been treated with a curative intent and patient is without evidence of active disease.
- Unresolved bacterial infection requiring treatment with antibiotics.
- Pregnant or lactating women may not participate in the study.
- Patients who have allergy to any of the study drugs or sulfa drugs.
- Patients infected with HIV-1 virus because of the undetermined effect of this chemotherapy regimen in patients with HIV-1 and the potential for serious interaction with anti-HIV medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Gemcitabine, Cisplatin, and Celecoxib in the Treatment of Metastatic Pancreatic Cancer
This study will examine an investigational (experimental) treatment using gemcitabine, cisplatin, and celecoxib. Preliminary studies have shown that this experimental treatment may be effective in reducing the size of cancerous tumors and/or preventing further tumor growth.
This is a phase II clinical trial studying the reactions of the patient's body and their tumor to the combination of gemcitabine, cisplatin, and celecoxib. The purpose of this study is to see if the tumor responds to this treatment and to determine how long the response lasts. This study will also look at what kind of side effects this experimental treatment causes and see how often these side effects occur. Blood levels of celecoxib will be measured to find out how this treatment affects factors (proteins) involved in new blood vessel formation and tumor growth (angiogenesis).
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine, Cisplatin, Celecoxib
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
CisplatinDrug
CelecoxibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the overall survival time in patients with metastatic pancreatic cancer treated with the combination of gemcitabine, cisplatin and celecoxib.
Measured: 12 months
Secondary outcomes (6)
To obtain data on overall time to disease progression
Measured: 12 months
To determine time to treatment failure
Measured: 12 months
To determine the tolerability of celecoxib with gemcitabine and cisplatin.
Measured: 12 months
To characterize the nature of the toxicity for this combination in this patient group.
Measured: 12 months
To determine objective tumor response
Measured: 12 months
To determine the influence of therapy on the blood levels of prostaglandins and angiogenesis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2003
- Primary completionNov 2003
- Study completionNov 2006
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.
- More trials run by University of Michigan Rogel 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Barbara Ann Karmanos Cancer Institute
- Investigators
- Mark Zalupski, M.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176813
- Sponsor's protocol ID
- UMCC 2001-071
- Other IDs
- C2442
- Status last verified
- Apr 2008
- First submitted
- 9 Sep 2005
- Last updated
- 6 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Gemcitabine, Cisplatin, and Celecoxib in the Treatment of Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00176813
- Acronym / sponsor ID
- UMCC 2001-071
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Barbara Ann Karmanos Cancer Institute
- Study start
- Mar 2003
- Primary completion
- Nov 2003 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 15 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.
This study will examine an investigational (experimental) treatment using gemcitabine, cisplatin, and celecoxib. Preliminary studies have shown that this experimental treatment may be effective in reducing the size of cancerous tumors and/or preventing further tumor growth.
This is a phase II clinical trial studying the reactions of the patient's body and their tumor to the combination of gemcitabine, cisplatin, and celecoxib. The purpose of this study is to see if the tumor responds to this treatment and to determine how long the response lasts. This study will also look at what kind of side effects this experimental treatment causes and see how often these side effects occur. Blood levels of celecoxib will be measured to find out how this treatment affects factors (proteins) involved in new blood vessel formation and tumor growth (angiogenesis).
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 (8 listed)
- Patients must have histologic or cytologic diagnosis of pancreatic adenocarcinoma.
- Patients must have clinical/radiologic evidence of metastatic disease (stage IV).
- Patients must not have received prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy is allowed, provided that the last day of therapy was at least 6 months prior to starting treatment.
- Patients must have performance status of 0-2 on the SWOG scale.
- Patients must have an estimated life expectancy of at least 12 weeks.
Key exclusion criteria (13 listed)
- Patients with endocrine tumors or lymphoma of the pancreas.
- Patients with locally advanced pancreatic cancer.
- Patients with a proven history (radiographic and/or endoscopic) of peptic ulcer or esophageal erosions within one year of enrollment onto the study.
- Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs.
- History of active central nervous system (CNS) metastases.
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 |
|---|---|---|
| Gemcitabine | Drug | – |
| Cisplatin | Drug | – |
| Celecoxib | Drug | – |
Primary outcome
To determine the overall survival time in patients with metastatic pancreatic cancer treated with the combination of gemcitabine, cisplatin and celecoxib.
Time frame: 12 months
6 secondary outcomes
To obtain data on overall time to disease progression
Time frame: 12 months
To determine time to treatment failure
Time frame: 12 months
To determine the tolerability of celecoxib with gemcitabine and cisplatin.
Time frame: 12 months
To characterize the nature of the toxicity for this combination in this patient group.
Time frame: 12 months
To determine objective tumor response
Time frame: 12 months
To determine the influence of therapy on the blood levels of prostaglandins and angiogenesis
Time frame: 12 months
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 6 May 2008.
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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.
Mark Zalupski, M.D. principal investigator
University of Michigan Rogel 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 Gemcitabine, Cisplatin and Celecoxib in people with Pancreatic Cancer, run by University of Michigan Rogel 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 13 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 6 May 2008. 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?
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?
To determine the overall survival time in patients with metastatic pancreatic cancer treated with the combination of gemcitabine, cisplatin and celecoxib. (time frame: 12 months). 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 6 May 2008.