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

This study has been withdrawn prior to enrollment.
(Study has been abandoned for lack of available funding.)
Sponsor:
Information provided by:
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00748163
First received: September 5, 2008
Last updated: August 31, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Drug: sunitinib malate
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of ABI-007 Plus Sunitinib as First Line Treatment for Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to objective tumor response as assessed by RECIST criteria [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity and adverse events as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: August 2008
Arms Assigned Interventions
Experimental: 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.
Drug: paclitaxel albumin-stabilized nanoparticle formulation Drug: sunitinib malate

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748163

Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Arkadiusz Dudek, MD Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Arkadiusz Dudek, M.D., Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00748163     History of Changes
Other Study ID Numbers: 2007LS098, 0802M26201, ABX080, GA6181W
Study First Received: September 5, 2008
Last Updated: August 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Masonic Cancer Center, University of Minnesota:
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Sunitinib
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014