Sequential Use of Low-dose Sunitinib With Chemotherapy in Advanced NSCLC After Failure of Conventional Regimen

May 7, 2013 updated by: LI Junling, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study of Efficacy and Safety of Sequential Low-dose Sunitinib With Chemotherapy in Advanced Non-small Cell Lung Cancer After Failure of Conventional Regimen

The purpose of this study is to determine whether sequential application of low-dose short-term sunitinib and chemotherapy is effective in the treatment of non-small cell lung cancer after failure of conventional therapy. Safety of this regimen will also be evaluated.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

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

  • China
      • Beijing, China, 100021
        • Recruiting
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologic or cytologic diagnosis of stage IIIB/IV NSCLC
  • ECOG PS: 0,1
  • Unidimensional or bi-dimensional measurable disease
  • Receive prior treatment including first-line platinum-based chemotherapy, standard second-line chemotherapy and 1 EGF/EGFR inhibitor
  • Evidence of disease progression
  • Life expectancy >12 weeks
  • Neutrophils > 1.5 109/l, Platelets > 100 109/l, Hemoglobin > 9g/dl, Total bilirubin < 1.5 UNL, AST (SGOT) and ALT (SGPT) < 2.5 UNL, Alkaline phosphatases < 5 UNL, Creatinine < 1 UNL

Exclusion Criteria:

  • Pre-existing hemoptysis of a severity > grade 3 by NCI CTCAE criteria within 4 weeks prior to study entry
  • Uncontrolled hypertension
  • CHF, angina or arrhythmias
  • LVEF < 1 UNL
  • Existing a second malignancy within 5 years
  • Infected with HIV

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sunitinib
Drug: Sunitinib, chemotherapy
sunitinib, 12.5mg/day, for 7 days before each cycle of chemotherapy; chemotherapy, single agent including docetaxel, albumin-bound paclitaxel, vinorelbine, gemcitabine, pemetrexed, or paclitaxel, as determined by the investigator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival
Time Frame: up to 2 years
The primary objective of this study is to evaluate the median progression-free survival of this sequential regimen.
up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: up to 2 years
To evaluate the median over-all survival of this regimen
up to 2 years
disease control rate
Time Frame: up to 6 months
To evaluate the disease-control rate of this regimen.
up to 6 months
Safety
Time Frame: up to 2 years
To evaluate the safety of this regimen including the rate and grade of adverse effects.
up to 2 years

Collaborators and Investigators

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

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

March 1, 2013

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

April 18, 2013

First Submitted That Met QC Criteria

May 7, 2013

First Posted (Estimate)

May 9, 2013

Study Record Updates

Last Update Posted (Estimate)

May 9, 2013

Last Update Submitted That Met QC Criteria

May 7, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-2013-041

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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