This is a Phase I study of the optimal dose, toxicities, and kinetics of an antisense oligonucleotide targeted against protein kinase C alpha when administered with chemotherapy consisting of carboplatin and paclitaxel. It is based on our prior Phase I trial, Protocol #482. Cohorts of 3 to 6 patients each are being entered into the study beginning at an antisense dose of 1.0 mg/kg/day over 14 days by continuous infusion. Carboplatin and paclitaxel are administered on day 4 of the antisense infusion. The doses of antisense oligonucleotide and carboplatin will be escalated sequentially in successive cohorts if the prior doses are well tolerated. We are presently enrolling patients in the final cohort of the Phase I Study. We plan to extend this study to an additional sixteen patients with non-small cell lung cancer at the final cohort's doses to evaluate these patients for responses. Six out of eight patients with non-small cell lung cancer had patial responses in our phase I study. Four patients have entered the trial in the first cohort. The main side effects seen thus far include diarrhea, nausea and vomiting, which are primarily due to the chemotherapy but may be exacerbated by the antisense drug. We plan to complete the study in the coming year.
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