ABI-007 in Treating Patients With Chemotherapy-Naïve Stage IV Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00077246|
Recruitment Status : Completed
First Posted : February 11, 2004
Last Update Posted : November 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: paclitaxel albumin-stabilized nanoparticle formulation||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||October 2008|
- Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of ABI-007
- Objective target lesion response (complete or partial) as measured by RECIST criteria
- Incidence of treatment-emergent adverse events and serious adverse events
- Nadir of myelosuppression
- Changes in hematologic and clinical chemistry values
- Changes in physical examination
- Incidence of dose modifications, dose interruptions, and/or premature discontinuation of study treatment
- Percentage of patients with stable disease for ≥ 16 weeks
- Percentage of patients with complete or partial target response (total response)
- Time to disease progression
- Duration of response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077246
|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|