Breast Cancer Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle
formulation, work in different ways to stop the growth of tumor cells, either by killing the
cells or by stopping them from dividing. Pemetrexed may stop the growth of tumor cells by
blocking some of the enzymes needed for cell growth. Giving paclitaxel albumin-stabilized
nanoparticle formulation together with pemetrexed may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel
albumin-stabilized nanoparticle formulation when given together with pemetrexed and to see
how well they work in treating patients with advanced non-small cell lung cancer, breast
cancer, or other solid tumors.
OBJECTIVES:
Primary
- Determine the safety 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)
Secondary
- Determine the preliminary efficacy of paclitaxel albumin-stabilized nanoparticle
formulation and pemetrexed disodium in these patients. (Phase I)
- Determine the overall survival of patients treated with this regimen. (Phase II)
- Evaluate the frequency and severity of toxicities associated with this regimen. (Phase
II)
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
unacceptable toxicity.
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
dose-limiting toxicity.
- 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.
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