NeoplasmPhase 2NCT00226005
PTK787 in Patients With Advanced Metastatic Pancreatic Adenocarcinoma
A Phase 2 study testing PTK787/ZK222584 in people with Neoplasm, run by Pancreatic Cancer Research Team at 7 sites in United States.
Trial summary
The purpose of this research study is to find out if an experimental drug called PTK787/ZK222584 might be effective against advanced or metastatic pancreatic cancer. In order for tumors to grow and spread to other parts of the body, they need to have a growing blood supply. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm
- What is being tested?
- PTK787/ZK222584
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2005to Feb 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
- Age > 18
- Zubrod performance status of 0 - 2
- Histological or cytological diagnosis of pancreatic adenocarcinoma
- Measurable or evaluable disease determined as per RECIST criteria
- Life expectancy > 12 weeks
- Written informed consent
- Patients must have failed or progressed on prior gemcitabine-based therapy for advanced or metastatic disease.
Who cannot join
- Islet cell or neuroendocrine carcinomas of the pancreas.
- History or presence of central nervous system disease.
- Patients with a history of another primary malignancy < 5 years
- Prior chemo therapy < 21 days prior to registration.
- Prior biologic or immunotherapy < 14 days prior to registration
- Prior full field radiotherapy < 28 days or limited field radiotherapy < 14 days prior to registration.
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- Major surgery < 28 days prior to registration.
- Patients who have received investigational drugs < 28 days prior to registration.
- Prior therapy with anti-VEGF agents.
- Pleural effusion or ascites that causes respiratory compromise.
- Female patients who are pregnant or breast feeding.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins
Baltimore, Maryland, 21231
Tower Hematology Oncology Medical Group
Beverly Hills, California, 90211-18500
Virginia Piper Cancer Institute/Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
South Texas Oncology and Hematology
San Antonio, Texas, 78229
Scottsdale Healthcare
Scottsdale, Arizona, 85259
University of Arizona/Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: Phase II Trial of PTK787/ZK222584 in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma Who Failed First-Line Gemcitabine Therapy.
The purpose of this research study is to find out if an experimental drug called PTK787/ZK222584 might be effective against advanced or metastatic pancreatic cancer.
In order for tumors to grow and spread to other parts of the body, they need to have a growing blood supply. Tumor cells have been shown to produce substances that stimulate the abnormal growth of new blood vessels that allow the tumor to grow. In adults, blood vessel cells normally divide very rapidly. It is thought that PTK787/ZK222584 may interfere with the growth of new blood vessels. A drug that interferes with the growth of new blood vessels might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels. Since normal blood vessel cells divide very rarely, it might be possible to stop tumor growth without harming normal tissues.
Read the detailed description
This is an open-label, phase II multi-center therapeutic trial investigating the efficacy and tolerability of PTK787/ZK222584 in patients with metastatic or advanced pancreatic cancer who failed first line gemcitabine-based therapy. The primary objective of this study is to evaluate the 6-month survival rate, time to progression, and tolerability of the regimen in pancreatic cancer patients treated with PTK787/ZK222584 as second-line therapy.
- Conditions
- Neoplasm
- Being tested
- PTK787/ZK222584
- Keywords
- pancreas, adenocarcinoma, cancer, metastatic, advanced cancer, Phase II, growth factor, VEGF, angiogenesis
- Medical subject headings
- Neoplasms, Adenocarcinoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTK787/ZK222584Drug
Also called bevacizumab
One arm: administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Vatalanib | Active comparator | Administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter. Receives: Drug: PTK787/ZK222584 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the 6-month survival rate and time to progression in pancreatic cancer patients treated with PTK787/ZK222584.
The Data Safety Monitoring Board met twice yearly while the study was active (2006-2008) to review data and each of the primary and secondary objectives.
Safety Issue: the only endpoint/outcome measure that was a safety issue was the second one (safety and tolerability of PTK)
Measured: DSMC Schedule
Secondary outcomes (3)
To assess the response rates of patients treated with PTK787/ZK222584.
The Data Safety Monitoring Board met twice yearly while the study was active (2006-2008) to review data and each of the primary and secondary objectives.
Measured: DSMC Schedule
To evaluate DCE-MRI as a surrogate of response to PTK787/ZK222584 therapy in pancreatic cancer patients.
The Data Safety Monitoring Board met twice yearly while the study was active (2006-2008) to review data and each of the primary and secondary objectives.
Measured: DSMC Schedule
To perform analysis of tissue, blood and plasma markers that may be helpful in assessing the likelihood of benefit from PTK787/ZK222584 therapy.
The Data Safety Monitoring Board met twice yearly while the study was active (2006-2008) to review data and each of the primary and secondary objectives.
Measured: DSMC Schedule
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startDec 2005
- Primary completionDec 2008
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pancreatic Cancer Research Team
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tomislav Dragovich, MD, PhD, Principal investigator, University of Arizona/Arizona Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226005
- Sponsor's protocol ID
- PCRT04-001
- Status last verified
- May 2012
- First submitted
- 22 Sep 2005
- Last updated
- 9 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of PTK787/ZK222584 in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma Who Failed First-Line Gemcitabine Therapy.
- ClinicalTrials.gov ID
- NCT00226005
- Acronym / sponsor ID
- PCRT04-001
- Conditions
- Neoplasm
- Keywords
- pancreas, adenocarcinoma, cancer, metastatic, advanced cancer, Phase II, growth factor, VEGF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Pancreatic Cancer Research TeamUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 26 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 purpose of this research study is to find out if an experimental drug called PTK787/ZK222584 might be effective against advanced or metastatic pancreatic cancer.
In order for tumors to grow and spread to other parts of the body, they need to have a growing blood supply. Tumor cells have been shown to produce substances that stimulate the abnormal growth of new blood vessels that allow the tumor to grow. In adults, blood vessel cells normally divide very rapidly. It is thought that PTK787/ZK222584 may interfere with the growth of new blood vessels. A drug that interferes with the growth of new blood vessels might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels. Since normal blood vessel cells divide very rarely, it might be possible to stop tumor growth without harming normal tissues.
Detailed description
This is an open-label, phase II multi-center therapeutic trial investigating the efficacy and tolerability of PTK787/ZK222584 in patients with metastatic or advanced pancreatic cancer who failed first line gemcitabine-based therapy. The primary objective of this study is to evaluate the 6-month survival rate, time to progression, and tolerability of the regimen in pancreatic cancer patients treated with PTK787/ZK222584 as second-line therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vatalanib | Active comparator | Drug: PTK787/ZK222584Administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter. |
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
- Zubrod performance status of 0 - 2
- Histological or cytological diagnosis of pancreatic adenocarcinoma
- Measurable or evaluable disease determined as per RECIST criteria
- Life expectancy > 12 weeks
Key exclusion criteria (11 listed)
- Islet cell or neuroendocrine carcinomas of the pancreas.
- History or presence of central nervous system disease.
- Patients with a history of another primary malignancy < 5 years
- Prior chemo therapy < 21 days prior to registration.
- Prior biologic or immunotherapy < 14 days prior to registration
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 |
|---|---|---|
| PTK787/ZK222584Also: bevacizumabOne arm: administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter. | Drug | Vatalanib |
Primary outcome
To evaluate the 6-month survival rate and time to progression in pancreatic cancer patients treated with PTK787/ZK222584.
Time frame: DSMC Schedule
The Data Safety Monitoring Board met twice yearly while the study was active (2006-2008) to review data and each of the primary and secondary objectives. Safety Issue: the only endpoint/outcome measure that was a safety issue was the second one (safety and tolerability of PTK)
3 secondary outcomes
To assess the response rates of patients treated with PTK787/ZK222584.
Time frame: DSMC Schedule
To evaluate DCE-MRI as a surrogate of response to PTK787/ZK222584 therapy in pancreatic cancer patients.
Time frame: DSMC Schedule
To perform analysis of tissue, blood and plasma markers that may be helpful in assessing the likelihood of benefit from PTK787/ZK222584 therapy.
Time frame: DSMC Schedule
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 9 May 2012.
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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.
Tomislav Dragovich, MD, PhD principal investigator
University of Arizona/Arizona Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PTK787/ZK222584 in people with Neoplasm, run by Pancreatic Cancer Research Team at 7 sites 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 11 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 9 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 evaluate the 6-month survival rate and time to progression in pancreatic cancer patients treated with PTK787/ZK222584. (time frame: DSMC Schedule). 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 9 May 2012.