ABI-007 in Treating Patients With Chemotherapy-Naïve Stage IV Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
OBJECTIVES: Primary 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. Secondary 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.

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

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: paclitaxel albumin-stabilized nanoparticle formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IV non-small cell lung cancer Evidence of inoperable local recurrence or metastasis Bone metastases or other nonmeasurable disease may not be only evidence of metastasis Measurable disease documented radiographically No evidence of active brain metastases or leptomeningeal involvement PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 OR Karnofsky 80-100% Life expectancy More than 12 weeks Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL Hepatic AST and ALT ≤ 2.5 times upper limit of normal (ULN) Bilirubin normal Alkaline phosphatase ≤ 2.5 times ULN (unless due to bone metastases and there is no radiologic evidence of hepatic metastases) Renal Creatinine ≤ 1.5 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception for 1 month before and during study participation No prior allergy or hypersensitivity to study drug No other concurrent active malignancy No pre-existing peripheral neuropathy grade 1 or greater No other concurrent clinically significant illness No concurrent serious medical risk factor involving any of the major organ systems that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for metastatic disease More than 4 weeks since prior cytotoxic chemotherapy No concurrent doxorubicin No other concurrent taxanes No concurrent anthracyclines Endocrine therapy Not specified Radiotherapy At least 3 weeks since prior radiotherapy to a major bone marrow-containing area More than 4 weeks since prior radiotherapy except to a non-target lesion Prior radiotherapy to a target lesion allowed provided there has been clear progression of the lesion since completion of radiotherapy Surgery Not specified Other Prior epidermal growth factor-targeted therapy allowed More than 4 weeks since prior investigational drugs No concurrent enrollment in another clinical trial in which investigational drugs are administered or investigational procedures are performed No concurrent treatment with any of the following: Ritonavir Saquinavir Indinavir Nelfinavir No concurrent anticonvulsants No other concurrent anticancer drugs No other concurrent investigational drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paclitaxel albumin-stabilized nanoparticle formulation|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of ABI-007 |  |  | 
| Objective target lesion response (complete or partial) as measured by RECIST criteria |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 
| Survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IV non-small cell lung cancer, recurrent non-small cell lung cancer