Bortezomib in Combination With Gemcitabine and Cisplatin in Advanced or Metastatic Non-Small Cell Lung Cancer

NCT01633645 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2015-09-28

No results posted yet for this study

Summary

The primary objective of this study is to establish the objective response rate (complete response + partial response) following treatment with VELCADE in combination with cisplatin plus gemcitabine in patients with locally advanced (Stage IIIb) or metastatic (stage IV non-small cell lung cancer (NSCLC) who have not received prior antineoplastic therapy for advanced disease

Conditions

  • Non Small Cell Lung Cancer
  • Metastatic

Interventions

DRUG

Bortezomib

Velcade

DRUG

Gemcitabine

Gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-days treatment cycle for a maximum of 8 cycles

DRUG

Cisplatin

Cisplatin 70 mg/m2 on day 1 of a 21-days treatment cycle for a maximum of 8 cycles

Sponsors & Collaborators

  • University Hospital of Crete

    lead OTHER

Principal Investigators

  • Vassilis Georgoulias, MD · University Hospital of Heraklion

  • Sofia Aggelaki, MD · University Hospital of Heraklion

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Greece

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01633645 on ClinicalTrials.gov