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

NCT ID: NCT00748163

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2008-08-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stage IV Non-Small Cell Lung Cancer Patients

Patients with stage IV non-small cell lung cancer treated with paclitaxel albumin-stabilized nanoparticle formulation and sunitinib malate as first-line therapy.

Group Type: EXPERIMENTAL

paclitaxel albumin-stabilized nanoparticle formulation

Intervention Type: DRUG

sunitinib malate

Intervention Type: DRUG

Interventions

paclitaxel albumin-stabilized nanoparticle formulation

Intervention Type: DRUG

sunitinib malate

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arkadiusz Dudek, MD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Other Identifiers

0802M26201

Identifier Type: OTHER

Identifier Source: secondary_id

ABX080

Identifier Type: OTHER

Identifier Source: secondary_id

GA6181W

Identifier Type: OTHER

Identifier Source: secondary_id

2007LS098

Identifier Type: -

Identifier Source: org_study_id