Trial Information

Summary: Combination Chemotherapy Treatment For Advanced Non-Small Cell Lung Cancer Patients Having Prior Chemotherapy

The purpose of this study is to compare the efficacy and safety of a weekly regimen of two FDA approved drugs in combination versus one FDA approved drug in patients with advanced non-small cell lung cancer who have received one previous chemotherapy.

Inclusion Criteria (subjects must meet the following criteria in order to be considered eligible for this study):

• Written informed consent
• Confirmed advanced non-small cell lung carcinoma (NSCLC)
• Received one prior chemotherapy for metastatic NSCLC. In addition, patients are allowed to have previously received a non-cytotoxic therapy, such as an endothelial growth factor receptor (EGFR) or angiogenesis inhibitor.
• Presence of either measurable or non-measurable disease by radiologic study or physical examination.
• Full recovery and at least 21 days from prior treatment for NSCLC.
• At least 3 weeks since last major surgery (lesser period is acceptable if deemed in the best interest of the patient).
• At least 7 days since prior radiotherapy.
• Adequate bone marrow reserve, and adequate kidney and liver function.

Exclusion Criteria (subjects cannot meet the following criteria in order to be considered eligible for this study):

• Symptoms of brain metastases requiring treatment with steroids.
• Active infection.
• Severe medical problems other than the diagnosis of NSCLC that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk.
• Ongoing or planned chemotherapy (other than treatment during this study), immunotherapy, radiotherapy, or investigational therapy for the treatment of NSCLC.
• Use of investigational drug within 30 days prior to the first dose of study medication.
• Women who are pregnant or lactating.
• Patients of child-bearing potential refusing to practice adequate contraception.
• Patients who cannot receive steroid premedication.

Healthy Volunteers: no
Gender: Both
Minimum Age: 18 Years
Maximum Age: N/A

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Trial listings updated: February 25, 2008 at 2:28:15 PM