Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Sunitinib as First-Line Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
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. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving paclitaxel albumin-stabilized nanoparticle formulation together with sunitinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving paclitaxel albumin-stabilized nanoparticle formulation together with sunitinib works as first-line therapy in treating patients with stage IV non-small cell lung cancer.

Detailed Description
-----------------
OBJECTIVES: Primary To determine the tumor response rate in patients with stage IV non-small cell lung cancer treated with paclitaxel albumin-stabilized nanoparticle formulation and sunitinib malate as first-line therapy. Secondary To determine the time to objective tumor response and duration of response in responding patients. To determine the time to treatment failure and overall survival of these patients. To characterize the toxicities of this regimen in these patients. OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients also receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed every 8 weeks until disease progression and then every 3 months for up to 1 year.

Official Title
-----------------
Phase II Study of ABI-007 Plus Sunitinib as First Line Treatment for Non-Small Cell Lung Cancer

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Stage IV disease At least 1 measurable lesion as defined by modified RECIST criteria No symptomatic or untreated brain metastases Prior brain metastases allowed provided the CNS disease has been treated and is considered stable and the patient has recovered from the acute toxic effects of the treatment prior to study entry PATIENT CHARACTERISTICS: Inclusion criteria: ECOG performance status 0-1 WBC ≥ 3.0 x 10^9/L ANC ≥ 1.5 x 10^9/L Platelet count ≥ 100 x 10^9/L Bilirubin ≤ 1.5 mg/dL AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if liver has tumor involvement) Creatinine ≤ 1.5 mg/dL LVEF ≥ 40% by MUGA Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment Exclusion criteria: Congestive heart failure, myocardial infarction, or coronary artery bypass graft within the past 12 months Ongoing severe or unstable angina Unstable arrhythmia requiring medication Sensory neuropathy ≥ grade 2 (according to NCI CTCAE v3.0) Known hypersensitivity to any of the agents used in this study Serious medical or psychiatric illness that, in the opinion of the enrolling investigator, is likely to interfere with study participation PRIOR CONCURRENT THERAPY: No prior systemic therapy for NSCLC More than 4 weeks since prior major surgery More than 7 days since prior and no concurrent potent CYP3A4 inhibitors, including any of the following: Ketoconazole Itraconazole Clarithromycin Erythromycin Diltiazem Verapamil Delavirdine Indinavir Saquinavir Ritonavir Atazanavir Nelfinavir More than 12 days since prior and no concurrent potent CYP3A4 inducers, including any of the following: Rifampin Rifabutin Carbamazepine Phenobarbital Phenytoin St. John's wort Efavirenz Tipranavir No concurrent treatment with a drug having proarrhythmic potential, including any of the following: Terfenadine Quinidine Procainamide Disopyramide Sotalol Probucol Bepridil Haloperidol Risperidone Indapamide Flecainide No other concurrent investigational agents

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stage IV Non-Small Cell Lung Cancer Patients<br>Patients with stage IV non-small cell lung cancer treated with paclitaxel albumin-stabilized nanoparticle formulation and sunitinib malate as first-line therapy. | Drug: paclitaxel albumin-stabilized nanoparticle formulation<br> <br> Drug: sunitinib malate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to objective tumor response as assessed by RECIST criteria |  | 1 Year | 
| Duration of response |  | 1 Year | 
| Time to treatment failure |  | 1 Year | 
| Overall survival |  | 1 Year | 
| Toxicity and adverse events as assessed by NCI CTCAE v3.0 |  | 1 Year | 

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