- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00281125
Phase I/II Trial of PTK787 and Pemetrexed With or Without Cisplatin for Lung Cancer
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
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89135
- Nevada Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
|
Secondary Outcome Measures
Outcome Measure |
---|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sunil Sharma, MD, Nevada Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Mesothelioma
- Mesothelioma, Malignant
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Folic Acid Antagonists
- Pemetrexed
- Vatalanib
Other Study ID Numbers
- NVCI05-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-Small Cell Lung Cancer and Pleural Mesothelioma
-
Assistance Publique Hopitaux De MarseilleCompletedNon Small Cell Lung Cancer (NSCLC) | Malignant Pleural Mesothelioma (MPM)France
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Non-Small Cell Lung Carcinoma | Recurrent Pleural Malignant Mesothelioma | Stage III Pleural Malignant Mesothelioma AJCC v7 | Stage IV Pleural Malignant Mesothelioma AJCC v7 | Stage IV Non-Small Cell Lung Cancer AJCC v7 | Stage IIIA Non-Small Cell Lung Cancer AJCC v7 | HLA-A*0201 Positive... and other conditionsUnited States
-
NanoAlvandCompletedNon Small Cell Lung Cancer | Malignant Pleural Mesothelioma
-
Swiss Group for Clinical Cancer ResearchActive, not recruitingNon-small Cell Lung Cancer | Malignant Pleural MesotheliomaSwitzerland
-
Wake Forest University Health SciencesWithdrawnLung Metastases | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Recurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma
-
Ohio State University Comprehensive Cancer CenterWithdrawnStage IIIB Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Stage III Malignant Mesothelioma | Stage IV Malignant Mesothelioma
-
Augusta UniversityTerminatedNon Small Cell Lung Cancer | Malignant Mesothelioma | Urothelial Carcinoma | Non-squamous Non-small-cell Lung CancerUnited States
-
University College, LondonCancer Research UKRecruitingSmall Cell Lung Cancer | Lung Cancer, Non-small Cell | Pleural MesotheliomaUnited Kingdom
-
Incyte CorporationWithdrawnAdvanced and/or Metastatic Solid Tumors | Stage IIIB Not Amenable to Curative Therapy to Stage IV Non-small Cell Lung Cancer | Advanced/Metastatic Unresectable Malignant Pleural Mesothelioma
-
Massachusetts General HospitalActive, not recruitingNon Small Cell Lung Cancer | Mesothelioma | Small-cell Lung Cancer | Cognitive Behavioral TherapyUnited States
Clinical Trials on PTK787 and Pemetrexed with or without Cisplatin
-
Avistone Biotechnology Co., Ltd.Not yet recruiting
-
Tata Memorial CentreAll India Institute of Medical Sciences, New Delhi; Amrita Institute of Medical...Not yet recruitingStage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8 | Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8India
-
North Carolina State UniversityUniversity of North Carolina, Chapel Hill; U.S. National Science FoundationUnknownSpinal Cord Injuries | Paraplegia, Spinal | Paraplegia, IncompleteUnited States
-
BeiGeneCompletedNon-Small Cell Lung CancerChina
-
University Hospital, LinkoepingRecruiting
-
Institut für Pharmakologie und Präventive MedizinEdwards LifesciencesActive, not recruitingAortic Valve StenosisAustria, Belgium, France, Netherlands, United Kingdom, Germany, Italy, Canada, Spain
-
University Hospital, GhentCompleted
-
University of TorontoIngredion IncorporatedCompletedDiabetes Prevention | Obesity PreventionCanada
-
Fisher and Paykel HealthcareMedical Research Institute of New Zealand; Alana HealthcareTerminatedChronic Obstructive Pulmonary Disease | COPDUnited States, New Zealand
-
University of AarhusAarhus University Hospital SkejbyCompletedRespiratory Aspiration of Gastric Content