Trial Information
A Phase I Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-naive Non-Small Cell Lung Cancer (NSCLC)
Inclusion Criteria:
- Chemotherapy-naive patients who are histologically or cytologically diagnosed NSCLC
with stage IIIB (not applicable of radical thoracic radiation) or stage IV
- Patients with normal organ function and bone marrow function
Exclusion Criteria:
- Given radical thoracic radiation for NSCLC or radiation for other than original
lesion within 3 weeks
- Any peripheral neuropathy above grade 2
- Any ascites, pleural effusion or pericardiac effusion which requires treatment
- Any uncontrolled concomitant illness
- Pregnant or breast-feeding
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants With a Dose Limited Toxicity at First Cycle
Outcome Description:
Dose Limited Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment.
Outcome Time Frame:
25 Days (first cycle)
Safety Issue:
Yes
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
2007_001
NCT ID:
NCT00424775
Start Date:
January 2007
Completion Date:
March 2007
Related Keywords:
- Neoplasms
- Non-Small Cell Lung Cancer (NSCLC)
- Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms