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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vatalanib | Active Comparator | Administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTK787/ZK222584 | Drug | One arm: administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | DSMC Schedule |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | DSMC Schedule |
| To evaluate DCE-MRI as a surrogate of response to PTK787/ZK222584 therapy in pancreatic cancer patients. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomislav Dragovich, MD, PhD | University of Arizona/Arizona Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale Healthcare | Scottsdale | Arizona | 85259 | United States | ||
| University of Arizona/Arizona Cancer Center |
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| Label | URL |
|---|---|
| web page for the nonprofit group, Pancreatic Cancer Research Team | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009385 | Neoplastic Processes |
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| ID | Term |
|---|---|
| C404768 | vatalanib |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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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. |
| 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. | DSMC Schedule |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Tower Hematology Oncology Medical Group | Beverly Hills | California | 90211-18500 | United States |
| Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins | Baltimore | Maryland | 21231 | United States |
| Virginia Piper Cancer Institute/Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| South Texas Oncology and Hematology | San Antonio | Texas | 78229 | United States |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |