Phase I/II Trial of PTK787 and Pemetrexed With or Without Cisplatin for Lung Cancer

NCT00281125 | Terminated Phase 1 DMC

• 1 other identifier: NVCI05-14
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer and Pleural Mesothelioma

Keywords

Non-Small Cell Lung Cancer; Pleural Mesothelioma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

Interventions

PTK787 and Pemetrexed with or without Cisplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-small cell carcinoma of squamous variety
• Patients with uncontrolled brain metastases

Sponsors & Collaborators

• Nevada Cancer Institute: lead

Study Sites (1)

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Mesothelioma, Malignant

Interventions

vatalanib; Pemetrexed; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Pleural Neoplasms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Sunil Sharma, MD

  Nevada Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 6, 2006
• First Posted: January 24, 2006
• Study Start: January 1, 2006
• Primary Completion: September 1, 2006
• Study Completion: August 1, 2008
• Last Updated: March 19, 2012

Record last verified: 2012-03

Locations

US (1)