Phase II Study of ABI-007 Plus Sunitinib as First Line Treatment for Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
Phase II Study of ABI-007 Plus Sunitinib as First Line Treatment for Non-Small Cell Lung Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Safety Issue:
No
Principal Investigator
Arkadiusz Dudek, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Masonic Cancer Center, University of Minnesota
Authority:
United States: Food and Drug Administration
Study ID:
2007LS098
NCT ID:
NCT00748163
Start Date:
August 2008
Completion Date:
Related Keywords:
- Lung Cancer
- stage IV non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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