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

NCT00748163 | Withdrawn Phase 2 DMC

• 4 other identifiers: 2007LS0980802M26201ABX080GA6181W
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer

Keywords

stage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Response rate

  1 Year

Secondary Outcomes (5)

• 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

Study Arms (1)

Stage IV Non-Small Cell Lung Cancer Patients

EXPERIMENTAL

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; Drug: sunitinib malate

Interventions

paclitaxel albumin-stabilized nanoparticle formulation DRUG

Stage IV Non-Small Cell Lung Cancer Patients

sunitinib malate DRUG

Stage IV Non-Small Cell Lung Cancer Patients

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Taxes; Sunitinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Arkadiusz Dudek, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 8, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: August 8, 2018

Record last verified: 2018-08