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Mesothelioma Related Clinical Trials:
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
- General Info - Purpose - Eligibility - Contacts & Locations - Additional Information
Status: Terminated
Sponsors and Collaborators: Nevada Cancer Institute
Information provided by: Nevada Cancer Institute
Government Identifier: NCT00281125
Condition: Non-Small Cell Lung Cancer and Pleural Mesothelioma
Intervention: Drug: PTK787 and Pemetrexed with or without Cisplatin
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.
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Study Completion Date: | September 2006 |
Detailed Description:
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 |
Criteria
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:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281125Locations
| United States, Nevada | |||||
| Nevada Cancer Institute | |||||
| Las Vegas, Nevada, United States, 89135 | |||||
Sponsors and Collaborators
| Nevada Cancer Institute |
Investigators
| Principal Investigator: | Sunil Sharma, MD | Nevada Cancer Institute |
Additional Information:
| Study ID Numbers: | NVCI05-14 |
| First Received: | January 6, 2006 |
| Last Updated: | September 6, 2006 |
| ClinicalTrials.gov Identifier: | NCT00281125 |
| Health Authority: | United States: Food and Drug Administration |
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