Pancreatic CancerPhase 1NCT00243854
Pilot Study Using Neoadj Chemo-Rad & EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer
A Phase 1 study testing Tarceva in people with Pancreatic Cancer, run by Indiana University at 1 site in United States.
Trial summary
To determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy concurrently with weekly gemcitabine and an EGFR tyrosine-kinase inhibitor (OSI-774, Tarceva) in the treatment of patients with resectable 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?
- Tarceva
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Oct 2011
- Phase
- Phase 1
- 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
- pathologically confirmed adenocarcinoma of the pancreas
- resectable disease
- tumor </= 6cm diameter
- ECOG performance 0-1
- Organ system fxn: granulocytes (>/=1800/uL); plt ct >/=100K; bili</=2mg; liver enzymes <2.5ULN; crt </=1.5;
- Normal CXR
- Negative pregnancy test
Who cannot join
- metastatic disease or peritoneal seeding based on cross-sectional imaging
- previous irradiation to the planned field
- prior chemotherapy or immunotherapy
- active infection
- active PUD
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: Pilot Study Using Neoadjuvant Chemo-Radiotherapy and EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer
To determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy concurrently with weekly gemcitabine and an EGFR tyrosine-kinase inhibitor (OSI-774, Tarceva) in the treatment of patients with resectable pancreatic cancer.
Read the detailed description
To determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy concurrently with weekly gemcitabine and an EGFR tyrosine-kinase inhibitor (OSI-774, Tarceva) in the treatment of patients with resectable pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- Tarceva
- Keywords
- Pancreatic Cancer, Resectable Pancreatic Cancer, adenocarcinoma of the pancreas
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TarcevaDrug
Tarceva: 100mg/day x 2 weeks (Days 1-14) +
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if giving chemotherapy, radiation, and Tarceva,(EGFR-tyrosine kinase inhibitor)will have side effects that will prevent surgery following this therapy
Measured: Surgery - No later than 6 weeks from the completion of Neoadjuvant Therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2005 (estimated)
- Study startNov 2005
- Primary completionAug 2010
- Study completionOct 2011
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Higinia Cardenes, M.D., PhD, Principal investigator, Indiana UniversityGabriela Chiorean, M.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243854
- Sponsor's protocol ID
- 0507-08 IUCRO-0130
- Status last verified
- Mar 2014
- First submitted
- 24 Oct 2005
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Using Neoadjuvant Chemo-Radiotherapy and EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00243854
- Acronym / sponsor ID
- 0507-08 IUCRO-0130
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Resectable Pancreatic Cancer, adenocarcinoma of the pancreas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Nov 2005
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 25 Oct 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.
To determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy concurrently with weekly gemcitabine and an EGFR tyrosine-kinase inhibitor (OSI-774, Tarceva) in the treatment of patients with resectable pancreatic cancer.
Detailed description
To determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy concurrently with weekly gemcitabine and an EGFR tyrosine-kinase inhibitor (OSI-774, Tarceva) in the treatment of patients with resectable pancreatic cancer.
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 (7 listed)
- pathologically confirmed adenocarcinoma of the pancreas
- resectable disease
- tumor </= 6cm diameter
- ECOG performance 0-1
- Organ system fxn: granulocytes (>/=1800/uL); plt ct >/=100K; bili</=2mg; liver enzymes <2.5ULN; crt </=1.5;
Key exclusion criteria (5 listed)
- metastatic disease or peritoneal seeding based on cross-sectional imaging
- previous irradiation to the planned field
- prior chemotherapy or immunotherapy
- active infection
- active PUD
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 |
|---|---|---|
| TarcevaTarceva: 100mg/day x 2 weeks (Days 1-14) + | Drug | – |
Primary outcome
To determine if giving chemotherapy, radiation, and Tarceva,(EGFR-tyrosine kinase inhibitor)will have side effects that will prevent surgery following this therapy
Time frame: Surgery - No later than 6 weeks from the completion of Neoadjuvant Therapy
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 18 Mar 2014.
- Indiana University Cancer Center websiteLink provided by the sponsor.
Related trials for Pancreatic Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Active, not recruitingPhase 2
Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer
Pancreatic Cancer
RecruitingPhase 2/3
Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
Pancreatic Neuroendocrine Tumor (pNET), Extra-Pancreatic Neuroendocrine Tumor (epNET)
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.
Higinia Cardenes, M.D., PhD principal investigator
Indiana University
Gabriela Chiorean, M.D. principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tarceva in people with Pancreatic Cancer, run by Indiana University 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 7 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 18 Mar 2014. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 if giving chemotherapy, radiation, and Tarceva,(EGFR-tyrosine kinase inhibitor)will have side effects that will prevent surgery following this therapy (time frame: Surgery - No later than 6 weeks from the completion of Neoadjuvant Therapy). 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 18 Mar 2014.