Phase I/II Trial of PTK787 and Pemetrexed With or Without Cisplatin for Lung Cancer
NCT ID: NCT00281125
Last Updated: 2012-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2006-01-31
2008-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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PTK787 and Pemetrexed with or without Cisplatin
Eligibility Criteria
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Inclusion Criteria
* Patients with advanced solid tumors who are refractory to standard treatments and/or standard treatments are not be available for the patient
Exclusion Criteria
* Patients with uncontrolled brain metastases
18 Years
ALL
No
Sponsors
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Nevada Cancer Institute
OTHER
Principal Investigators
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Sunil Sharma, MD
Role: PRINCIPAL_INVESTIGATOR
Nevada Cancer Institute
Locations
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Nevada Cancer Institute
Las Vegas, Nevada, United States
Countries
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Other Identifiers
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NVCI05-14
Identifier Type: -
Identifier Source: org_study_id
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