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

NCT01850147 | Unknown Phase 2

• 1 other identifier: SU-2013-041
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• progression-free survival

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

  up to 2 years

Secondary Outcomes (3)

• overall survival

  up to 2 years

• disease control rate

  up to 6 months

• Safety

  up to 2 years

Study Arms (1)

Sunitinib

EXPERIMENTAL

Drug: Sunitinib, chemotherapy

Interventions

Sunitinib, chemotherapy DRUG

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

Sunitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Sunitinib; Drug Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics

Central Study Contacts

Junling Li

CONTACT

86-13801178891; drlijunling@yahoo.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief physician

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: May 9, 2013
• Study Start: March 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 9, 2013

Record last verified: 2013-05

Locations

CN (1)