ABI-007 in Treating Patients With Chemotherapy-Naïve Stage IV Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I/II trial is studying the side effects and best dose of ABI-007 and to see how well it works in treating patients with stage IV non-small cell lung cancer.
Drug: paclitaxel albumin-stabilized nanoparticle formulation
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Phase I/II Trial Of ABI-007 (A CREMOPHOR® El-Free, Protein Stabilized, Nanoparticle Paclitaxel) Administered Weekly In Chemotherapy Naive Patients With Advanced Non-Small Cell Lung Cancer|
- Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of ABI-007 [ Designated as safety issue: Yes ]
- Objective target lesion response (complete or partial) as measured by RECIST criteria [ Designated as safety issue: No ]
- Incidence of treatment-emergent adverse events and serious adverse events [ Designated as safety issue: Yes ]
- Nadir of myelosuppression [ Designated as safety issue: No ]
- Changes in hematologic and clinical chemistry values [ Designated as safety issue: No ]
- Changes in physical examination [ Designated as safety issue: No ]
- Incidence of dose modifications, dose interruptions, and/or premature discontinuation of study treatment [ Designated as safety issue: No ]
- Percentage of patients with stable disease for ≥ 16 weeks [ Designated as safety issue: No ]
- Percentage of patients with complete or partial target response (total response) [ Designated as safety issue: No ]
- Time to disease progression [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Survival [ Designated as safety issue: No ]
|Study Start Date:||September 2003|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose and dose-limiting toxicity of paclitaxel (albumin-stabilized Nanoparticle formulation) (ABI-007) in patients with chemotherapy-naïve stage IV non-small cell lung cancer.
- Determine the antitumor activity of this drug in these patients.
- Determine the safety and tolerability of this drug in these patients.
- Determine the time to disease progression in patients treated with this drug.
- Determine duration of response in patients treated with this drug.
- Determine survival of patients treated with this drug.
OUTLINE: This is an open-label, dose-escalation study.
- Phase I: Patients receive paclitaxel (albumin-stabilized Nanoparticle formulation) (ABI-007) IV on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of ABI-007 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 ABI-007 as above at the MTD (determined in phase I). Patients are followed monthly for 6 months and then every 3 months for 1.5 years.
PROJECTED ACCRUAL: A total of 64 patients will be accrued for this study.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Naiyer Rizvi, MD||Memorial Sloan-Kettering Cancer Center|