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

Primary Purpose

Cancer, Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Sunitinib, chemotherapy

About this trial

This is an interventional treatment trial for Cancer focused on measuring sunitinib, chemotherapy, non-small cell lung cancer, NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sunitinib

Arm Description

Outcomes

Primary Outcome Measures

progression-free survival

The primary objective of this study is to evaluate the median progression-free survival of this sequential regimen.

Secondary Outcome Measures

overall survival

To evaluate the median over-all survival of this regimen

disease control rate

To evaluate the disease-control rate of this regimen.

Safety

To evaluate the safety of this regimen including the rate and grade of adverse effects.

Full Information

NCT ID

NCT01850147

First Posted

April 18, 2013

Last Updated

May 7, 2013

Sponsor

Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01850147

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Unknown status

Study Start Date

March 2013 (undefined)

Primary Completion Date

October 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer, Lung Cancer

Keywords

sunitinib, chemotherapy, non-small cell lung cancer, NSCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sunitinib

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Sunitinib, chemotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

progression-free survival

Description

The primary objective of this study is to evaluate the median progression-free survival of this sequential regimen.

Time Frame

up to 2 years

Secondary Outcome Measure Information:

Title

overall survival

Description

To evaluate the median over-all survival of this regimen

Time Frame

up to 2 years

Title

disease control rate

Description

To evaluate the disease-control rate of this regimen.

Time Frame

up to 6 months

Title

Safety

Description

To evaluate the safety of this regimen including the rate and grade of adverse effects.

Time Frame

up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Junling Li

Phone

86-13801178891

drlijunling@yahoo.cn

Facility Information:

Facility Name

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

City

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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