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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer and Pleural Mesothelioma

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Trial Information

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.

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Principal Investigator

Sunil Sharma, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nevada Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

NVCI05-14

NCT ID:

NCT00281125

Start Date:

January 2006

Completion Date:

August 2008

Related Keywords:

  • Non-Small Cell Lung Cancer and Pleural Mesothelioma
  • Non-Small Cell Lung Cancer
  • Pleural Mesothelioma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Mesothelioma

Name

Location

Nevada Cancer InstituteLas Vegas, Nevada  89135