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

• Status: Withdrawn
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel; Sunitinib

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