Phase I/II Trial of Abraxane® (ABI-007) and Alimta® (Pemetrexed) in Advanced Solid Tumors With Emphasis on Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer
- Determine the safety and feasibility of paclitaxel albumin-stabilized nanoparticle
formulation when administered with pemetrexed disodium in patients with advanced
non-small cell lung cancer, breast cancer, or other solid tumors. (Phase I)
- Determine the efficacy of this regimen, as measured by objective tumor response rate
(RECIST criteria), in these patients. (Phase II)
- Determine the maximum tolerated dose of this regimen in these patients. (Phase I)
- Determine the preliminary efficacy of paclitaxel albumin-stabilized nanoparticle
formulation and pemetrexed disodium in these patients. (Phase I)
- Determine the progression-free survival and overall survival of patients treated with
this regimen. (Phase II)
- Evaluate the frequency and severity of toxicities associated with this regimen. (Phase
OUTLINE: This is a phase I, dose-escalation study of paclitaxel albumin-stabilized
nanoparticle formulation followed by an open-label, phase II study.
- Phase I: Patients receive pemetrexed disodium IV over 10 minutes and paclitaxel
albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1. Treatment
repeats every 21 days for up to 6 courses in the absence of disease progression or
Cohorts of 3-6 patients receive escalating doses of paclitaxel albumin-stabilized
nanoparticle formulation until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience
- Phase II: Patients receive pemetrexed disodium and paclitaxel albumin-stabilized
nanoparticle formulation at the MTD as in phase I.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 73 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: Safety combining ABI-007 with pemetrexed in patients with advanced solid tumors
Measure toxicities using CTCAE 3.0
Toxicity will be assessed on day 8, 15 and subsequently at the beginning of every cycle.
David R. Gandara, MD
University of California, Davis
United States: Food and Drug Administration
|University of California Davis Cancer Center||Sacramento, California 95817|