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

Phase II Study of ABI-007 Plus Sunitinib as First Line Treatment for Non-Small Cell Lung Cancer

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.

Study Overview

• Status: Withdrawn
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: sunitinib malate; Drug: paclitaxel albumin-stabilized nanoparticle formulation

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.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: sunitinib malate; Drug: paclitaxel albumin-stabilized nanoparticle formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate	1 Year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2008
• Primary Completion (Anticipated): August 1, 2008
• Study Completion (Anticipated): August 1, 2008

Study Registration Dates

• First Submitted: September 5, 2008
• First Submitted That Met QC Criteria: September 5, 2008
• First Posted (Estimate): September 8, 2008

Study Record Updates

• Last Update Posted (Actual): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 6, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: stage IV non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Paclitaxel; Sunitinib; Albumin-Bound Paclitaxel
• Other Study ID Numbers: 2007LS098; 0802M26201 (Other Identifier: IRB, University of Minnesota); ABX080 (Other Identifier: Abraxis); GA6181W (Other Identifier: Pfizer)