Sunitinib Malate in Treating Patients With Small Cell Lung Cancer

July 25, 2018 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Phase II Study of Sunitinib (SU011248) in Patients With Small Cell Lung Cancer Who Are Either Chemo-naïve (Extensive Disease) or Have a "Sensitive" Relapse

RATIONALE: Sunitinib malate 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.

PURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients with small cell lung cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To assess the therapeutic activity of sunitinib malate in patients with either chemonaïve extensive stage or sensitive relapsed small cell lung cancer.

Secondary

  • To characterize the safety of sunitinib malate in these patients.

Tertiary

  • To determine the potential of FDG-PET-scan to serve as a surrogate marker of response for the antiangiogenic activity of the compound.

OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (chemonaïve extensive stage vs sensitive relapse at least 3 months after stopping chemotherapy).

Patients receive oral sunitinib malate once daily for up to 1 year in the absence of disease progression or unacceptable toxicity.

Patients undergo fludeoxyglucose F 18 positron emission tomography of the chest at week 4. Blood samples and bronchial washings and brushings may be collected at baseline and at 4 and 8 weeks after start of therapy for further analysis.

After completion of study treatment, patients are followed up every 3 months.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1007 MB
        • Vrije Universiteit Medisch Centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 confirmed small cell lung cancer

    • Chemotherapy naïve (extensive stage) OR sensitive relapse (> 3 months since induction therapy) disease
  • Measurable disease, as defined by RECIST criteria
  • No brain metastases as assessed by CT scan or MRI performed < 1 week before treatment

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Life expectancy > 12 weeks
  • Absolute neutrophil count ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • AST and ALT ≤ 2.5 x upper limit of normal (ULN) (≤ 5 x ULN if liver function abnormalities are due to underlying malignancy)
  • Total serum bilirubin ≤ 1.5 x ULN
  • Serum albumin ≥ 3.0 g/dL
  • Negative pregnancy test
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 3 months after study treatment
  • No spinal cord compression, carcinomatous meningitis, or leptomeningeal disease
  • No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus within the past 6 months
  • No NCI CTCAE grade 3 hemorrhage within the past 4 weeks
  • No hypertension (> 150/100 mm Hg) that cannot be controlled with standard antihypertensive agents
  • No ongoing cardiac dysrhythmias of grade ≥ 2, atrial fibrillation of any grade, or QTc interval > 450 msec for males or > 470 msec for females
  • No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study drug administration or may interfere with the interpretation of study results, and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
  • No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

PRIOR CONCURRENT THERAPY:

  • More than 4 weeks since prior chemotherapy, surgery, or investigational agents
  • At least 1 month since prior radiotherapy except for palliative radiotherapy to non-target lesions
  • No prior treatment with sunitinib malate (SU011248) or other receptor tyrosine kinase inhibitors
  • No concurrent treatment with steroids
  • No concurrent treatment with a drug having proarrhythmic potential (i.e., terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide)
  • More than 7 and 12 days and no concurrent potent CYP3A4 inhibitors and inducers, respectively
  • Concurrent coumarin-derivative anticoagulants, such as warfarin (Coumadin®) up to 2 mg daily are permitted for prophylaxis of thrombosis
  • No other concurrent anticancer treatments, including chemotherapy, immunotherapy, targeted agents, hormonal cancer therapy, radiation therapy, or experimental treatments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Disease control rate (percentage of patients with complete response, partial response, or stable disease) 8 weeks after beginning treatment according to RECIST criteria

Secondary Outcome Measures

Outcome Measure
Duration of response
Duration of survival
Response rate every 4 weeks according to RECIST criteria
Duration of progression-free survival
Toxicity according to NCI CTCAE version 3.0
Accuracy of FDG-PET scan as a potential early surrogate marker of antiangiogenic activity for response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Principal Investigator: Egbert F. Smit, MD, Free University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

August 5, 2009

First Submitted That Met QC Criteria

August 5, 2009

First Posted (ESTIMATE)

August 6, 2009

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 25, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-08061
  • EU-20910
  • 2006-002485-19 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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