Conditions: Advanced Non-small Cell Lung Cancer
Keywords: paclitaxel poliglumex xyotax alimta advanced non-small cell lung cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 14
Healthy volunteers: no

Brief summary:
This is a non-randomized, single-arm, single-institution, open label, two-stage phase II and dose-ranging study designed to evaluate the efficacy and safety of paclitaxel poliglumex in combination with pemetrexed in patients with advanced stage IIIB or stage IV NSCLC.

Detailed description:
Primary objective

To evaluate the overall response rate (complete plus partial responses by RECIST criteria) to the combination of paclitaxel poliglumex and pemetrexed as therapy in patients with advanced NSCLC.

Secondary Objectives

To evaluate the safety and adverse event profile of the combination of paclitaxel poliglumex and pemetrexed as therapy in patients with advanced NSCLC.

To evaluate the duration of response, time to progression, and overall survival of advanced NSCLC treated with the combination of paclitaxel poliglumex and pemetrexed.

To compare the overall response rate using three-dimensional reconstruction of target lesions by Medical Metrx Solutions (MMS) and RECIST criteria.

Arms:
arm 1: The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued.

Interventions: intervention 1: paclitaxel poliglumex, pemetrexed
Intervention descriptions: intervention 1: The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued

Protocol document: