NCT00191620

Brief Summary

The purposes of this study are to determine: How standard gemcitabine plus cisplatin compares to fixed dose rate of gemcitabine plus cisplatin in the treatment of non-small cell lung cancer. The safety of standard gemcitabine plus cisplatin and any side effects that might be associated with it as compared to a fixed dose rate of gemcitabine plus cisplatin.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2004

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

January 26, 2007

Status Verified

January 1, 2007

First QC Date

September 12, 2005

Last Update Submit

January 24, 2007

Conditions

Non-Small-Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

  • To evaluate the objective response rate (ORR) of the standard (30 minute infusion) versus a fixed dose rate (10 mg/m2/minute) of gemcitabine combined with cisplatin as treatment for advanced NSCLC after treatment completion.

Secondary Outcomes (2)

  • To evaluate progression-free survival of the standard versus a fixed dose rate of gemcitabine combined with cisplatin as treatment for advanced NSCLC.

  • To evaluate incidence of laboratory and non laboratory adverse events by maximum Common Toxicity Criteria (CTC) toxicity grade and relationship to study drug of the standard versus a fixed dose rate of gemcitabine combined with cisplatin as treatment for

Interventions

GemcitabineDRUG
cisplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age
  • Histologically or cytologically confirmed diagnosis of NSCLC
  • Have provided written informed consent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Adequate organ function

You may not qualify if:

  • Prior chemotherapy or biologic therapy (approved or experimental) for NSCLC
  • Presence of uncontrolled central nervous system (CNS) metastases
  • Inability to comply with protocol or study procedures
  • Pregnancy
  • Breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/ GMT - 5 hours, EST), or speak with your personal physician

Buenos Aires, Argentina

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/ GMT - 5 hours, EST), or speak with your personal physician

São Paulo, Brazil

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/ GMT - 5 hours, EST), or speak with your personal physician

Santiago, Chile

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/ GMT - 5 hours, EST), or speak with your personal physician

Mexico City, Mexico

Location

Related Publications (1)

  • Pereira JR, Fein L, Del Giglio A, Blajman CR, Richardet E, Schwartsmann G, Orlando M, Hall BJ, West TM, van Kooten M. Gemcitabine administered as a short infusion versus a fixed dose rate in combination with cisplatin for the treatment of patients with advanced non-small cell lung cancer. Lung Cancer. 2007 Oct;58(1):80-7. doi: 10.1016/j.lungcan.2007.05.004. Epub 2007 Jun 22.

    PMID: 17588704DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

GemcitabineCisplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/ GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

March 1, 2004

Study Completion

May 1, 2006

Last Updated

January 26, 2007

Record last verified: 2007-01

Locations

BR(1)ME(1)CL(1)AR(1)