Phase II Study of Combination of Paclitaxel Poliglumex and Alimta for Advanced Non-small Cell Lung Cancer (NSCLC)

PHASE2CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
Advanced Non-small Cell Lung Cancer
Interventions
DRUG

paclitaxel poliglumex, pemetrexed

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

Trial Locations (1)

03756

Dartmouth-Hitchcock Medical Center, Lebanon

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

CTI BioPharma

INDUSTRY

lead

Dartmouth-Hitchcock Medical Center

OTHER