Pancreatic CancerPhase 1TARTNCT00735306
Phase I/II Trial of Radiation, Avastin and Tarceva for Pancreatic Adenocarcinoma
A Phase 1 study testing Avastin, Tarceva and Radiation Therapy in people with Pancreatic Cancer, run by Duke University at 1 site in United States.
Trial summary
The primary purpose of this trial is to define the maximum tolerated and/or recommended phase II dose of the combination of Avastin and Tarceva in patients undergoing radiation therapy for carcinoma of the pancreas. 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?
- Avastin, Tarceva and Radiation Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Oct 2011
- Phase
- Phase 1
- 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
- Age > 18 years
- Histologically and/or cytologically confirmed adenocarcinoma of the pancreas, T1-4, N0-1, M0. Patients should have disease for which combined modality therapy is indicated.
- Performance status 0-2
- Life expectancy > 3 months
- Adequate hematologic, renal, hepatic function
- Calculated creatinine Cl > 50 mL/min
- Use of effective means of contraception in patients of child-bearing potential.
Who cannot join
- No prior therapy for pancreatic cancer
- Previous treatment with bevacizumab or erlotinib
- Evidence of duodenal invasion or gastric outlet obstruction
- Presence of bleeding diathesis or coagulopathy
- History or prior arterial thrombotic event
- Conditions leading to inadequate gastrointestinal tract absorption
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- Poorly controlled diarrhea .
- Presence of baseline proteinuria or renal dysfunction (CrCl < 50 (Cockcroft-Gault equation)
- Inadequately controlled hypertension
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- Clinically significant peripheral vascular disease
- Presence of central nervous system or brain metastases
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
- Pregnant or lactating females
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
- Serious, non-healing wound, ulcer, or bone fracture
- Inability to comply with study and/or follow-up procedures
- Treatment for other carcinomas within the last five years, except cured non-melanoma skin cancer, curatively treated in-situ cervical cancer, or localized prostate cancer with a current PSA of <1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry.
- Comorbid conditions that would complicate safety or compliance
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Phase I/II Trial of Radiation, Avastin and Tarceva for Resectable or Locally Advanced Pancreatic Adenocarcinoma
The primary purpose of this trial is to define the maximum tolerated and/or recommended phase II dose of the combination of Avastin and Tarceva in patients undergoing radiation therapy for carcinoma of the pancreas. An additional primary objective is to describe the frequency and nature of grade III/IV and grade I/II toxicities associated with this regimen. Secondary objectives include describing 1-year disease-free survival and overall survival rates as well as to estimate clinical and pathologic complete response rates associated with this regimen.
Read the detailed description
This is a phase I/II study in which up to 18 patients will be enrolled in the phase I portion and up to an additional 26 patients in the phase II portion. Patients will be treated with Tarceva (cohort specified dose), along with fixed doses of Avastin and radiation therapy.
Avastin will be given as an IV dose on days 1, 15, and 29. Tarceva will be given as a once daily by mouth. On radiation days Tarceva will be taken immediately before or after XRT.
XRT will be given to a total dose of 50.4 Gy in 28 fractions, each fraction given once daily on Monday through Friday for 5.5 weeks
- Conditions
- Pancreatic Cancer
- Being tested
- Avastin, Tarceva, Radiation Therapy
- Keywords
- Locally advanced, Unresectable
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvastinDrug
Also called bevacizumab
Avastin 10 mg/kg IV on days 1, 15 and 29 Begins the first day of radiation therapy
TarcevaDrug
Also called erlotinib
Daily by mouth per assigned dose, for 5.5 weeks Begins the first day of radiation therapy
Radiation TherapyRadiation
Radiation to the pancreas Monday through Friday for 28 treatments
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Avastin, Tarceva and Radiation Therapy Receives: Drug: Avastin; Drug: Tarceva; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tarceva Maximum Tolerated Dose in mg
Tarceva maximum tolerated dose in mg
Measured: 1 yr
Secondary outcomes (2)
Number of Dose Limiting Toxicities
Measured: Within 30 days of completing radiation
One Year Overall Survival From Time of Diagnosis
One year survival from time of diagnosis for patients who completed this regimen
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2011
- Study completionOct 2011
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.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Brian Czito, MD, Principal investigator, Duke University Medical Center, Dept Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735306
- Sponsor's protocol ID
- Pro00001597
- Acronym
- TART
- Status last verified
- Apr 2015
- First submitted
- 13 Aug 2008
- Last updated
- 18 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Radiation, Avastin and Tarceva for Resectable or Locally Advanced Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00735306
- Acronym / sponsor ID
- TART / Pro00001597
- Conditions
- Pancreatic Cancer
- Keywords
- Locally advanced, Unresectable
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jul 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Posted 24 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this trial is to define the maximum tolerated and/or recommended phase II dose of the combination of Avastin and Tarceva in patients undergoing radiation therapy for carcinoma of the pancreas. An additional primary objective is to describe the frequency and nature of grade III/IV and grade I/II toxicities associated with this regimen. Secondary objectives include describing 1-year disease-free survival and overall survival rates as well as to estimate clinical and pathologic complete response rates associated with this regimen.
Detailed description
This is a phase I/II study in which up to 18 patients will be enrolled in the phase I portion and up to an additional 26 patients in the phase II portion. Patients will be treated with Tarceva (cohort specified dose), along with fixed doses of Avastin and radiation therapy.
Avastin will be given as an IV dose on days 1, 15, and 29. Tarceva will be given as a once daily by mouth. On radiation days Tarceva will be taken immediately before or after XRT.
XRT will be given to a total dose of 50.4 Gy in 28 fractions, each fraction given once daily on Monday through Friday for 5.5 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Avastin, Drug: Tarceva, Radiation: Radiation TherapyAvastin, Tarceva and Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years
- Histologically and/or cytologically confirmed adenocarcinoma of the pancreas, T1-4, N0-1, M0. Patients should have disease for which combined modality therapy is indicated.
- Performance status 0-2
- Life expectancy > 3 months
- Adequate hematologic, renal, hepatic function
Key exclusion criteria (20 listed)
- No prior therapy for pancreatic cancer
- Previous treatment with bevacizumab or erlotinib
- Evidence of duodenal invasion or gastric outlet obstruction
- Presence of bleeding diathesis or coagulopathy
- History or prior arterial thrombotic event
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 |
|---|---|---|
| AvastinAlso: bevacizumabAvastin 10 mg/kg IV on days 1, 15 and 29 Begins the first day of radiation therapy | Drug | 1 |
| TarcevaAlso: erlotinibDaily by mouth per assigned dose, for 5.5 weeks Begins the first day of radiation therapy | Drug | 1 |
| Radiation TherapyRadiation to the pancreas Monday through Friday for 28 treatments | Radiation | 1 |
Primary outcome
Tarceva Maximum Tolerated Dose in mg
Time frame: 1 yr
Tarceva maximum tolerated dose in mg
2 secondary outcomes
Number of Dose Limiting Toxicities
Time frame: Within 30 days of completing radiation
One Year Overall Survival From Time of Diagnosis
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Brian Czito, MD principal investigator
Duke University Medical Center, Dept Radiation Oncology
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 Avastin, Tarceva and Radiation Therapy in people with Pancreatic Cancer, run by Duke 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 20 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 Jun 2015. 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?
Yes. Results are posted in the registry (first posted 24 Nov 2011). 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?
Tarceva Maximum Tolerated Dose in mg (time frame: 1 yr). 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 Jun 2015.