Phase I/II Trial of PTK787 and Pemetrexed With or Without Cisplatin for Lung Cancer
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Purpose
This is an open-label, two-arm, multicenter Phase IA/II dose-escalation study of PTK787 in combination with Pemetrexed alone (Cohort 1) or Pemetrexed and Cisplatin (Cohort 2).
This study is designed to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of PTK787 when administered in combination with Pemetrexed or Pemetrexed and Cisplatin, and to characterize the safety, tolerability, biologic activity, and PK profile of PTK787 in adult patients with advanced non-small cell lung cancers and mesotheliomas.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer and Pleural Mesothelioma |
Drug: PTK787 and Pemetrexed with or without Cisplatin |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Two-Cohort Phase I/II Trial of PTK787 and Pemetrexed With or Without Cisplatin in Patients With Advanced Non-Small Cell Lung Cancers and Malignant Pleural Mesotheliomas |
- To determine the Maximum tolerated dose (MTD) and Dose Limiting toxicities (DLTs) of a combination of Pemetrexed and PTK787/ZK222584 (Cohort 1) and a combination of Pemetrexed with Cisplatin and PTK787/ZK222584 (Cohort 2) in patients
- To determine the preliminary evidence of safety of the above combinations in patients with non-small cell lung cancers and/or mesotheliomas (in the expansion cohorts)
- To determine the pharmacokinetics of PTK787/ZK222584 in combination with Pemetrexed and Cisplatin
- To determine the pharmacokinetics of Pemetrexed in combination with PTK787/ZK 222584
- To determine the effect of therapy with the combination on plasma levels of VEGF A, B, C and D and on plasma levels of soluble VEGF-R2.
- To determine the relationship between PTK787/ZK 222584 and Pemetrexed pharmacokinetics and plasma levels of VEGF A, B, C, D, soluble VEGF-R2, and exploratory chemotherapeutic response biomarkers.
- To determine the baseline expression of VEGF-R2 by immunohistochemistry in patients where paraffin blocks/slides are available.
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2006 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
This is an open-label, two-arm, multicenter Phase IA/II dose-escalation study of PTK787 in combination with Pemetrexed alone (Cohort 1) or Pemetrexed and Cisplatin (Cohort 2).
This study is designed to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of PTK787 when administered in combination with Pemetrexed or Pemetrexed and Cisplatin, and to characterize the safety, tolerability, biologic activity, and PK profile of PTK787 in adult patients with advanced non-small cell lung cancers and mesotheliomas.
In cohort 1, PTK787 will be administered orally every 12 hours on days 2-42 of a 42-day cycle. In addition, Pemetrexed will be administered on days 1 and 22.
In cohort 2, PTK787 will be administered orally every 12 hours on days 2-42 of a 42 day cycle. In addition, Pemetrexed will be administered on days 1 and 22. Thirty minutes after Pemetrexed administration, Cisplatin will be infused on days 1 and 22.
In the current study, initially patients will be treated on Cohort 1 (Pemetrexed + PTK787). Once an MTD determination is made on this cohort (or PTK787 has been escalated to the maximum dose of 750 mg Q12h enrollment will begin on Cohort 2. At the MTD dose, both cohorts will be expanded to a minimum of 20 patients to determine additional safety of the combinations.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with advanced non-small cell lung cancers (non-squamous variety and advanced mesotheliomas
- Patients with advanced solid tumors who are refractory to standard treatments and/or standard treatments are not be available for the patient
Exclusion Criteria:
- Non-small cell carcinoma of squamous variety
- Patients with uncontrolled brain metastases
Contacts and Locations| United States, Nevada | |
| Nevada Cancer Institute | |
| Las Vegas, Nevada, United States, 89135 | |
| Principal Investigator: | Sunil Sharma, MD | Nevada Cancer Institute |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00281125 History of Changes |
| Other Study ID Numbers: | NVCI05-14 |
| Study First Received: | January 6, 2006 |
| Last Updated: | March 15, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Nevada Cancer Institute:
|
Non-Small Cell Lung Cancer Pleural Mesothelioma |
Additional relevant MeSH terms:
|
Mesothelioma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Mesothelial |
Pemetrexed Cisplatin Vatalanib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013