NCT00112346

Brief Summary

The primary purpose of this study is to estimate the number of patients with non-small cell lung cancer whose tumor responds to the treatments given in this study.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2005

Geographic Reach
2 countries

38 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

January 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

1.9 years

First QC Date

June 1, 2005

Last Update Submit

October 26, 2015

Conditions

Non-Small-Cell Lung Carcinoma

Keywords

Non-Small Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • tumor response per treatment arm

Secondary Outcomes (1)

  • disease control, symptom response, symptomatic progression, & progression free survival.

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: Cetuximab + platinum + gemcitabine

B

ACTIVE COMPARATOR
Drug: Platinum + Gemcitabine

Interventions

Cetuximab + platinum + gemcitabineDRUG

Solution, IV, Cetuximab: 400mg/m2 on Day 1 then given weekly at 250mg/m2 starting on Day 8 + Gemcitabine given at 1250mg/m2 (Day 1 \& Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks. Cetuximab is given weekly, Maximum of 6 cycles (18 weeks) Cetuximab will be continued during the period following discontinuation of chemotherapy, until disease progression or cetuximab intolerance.

Also known as: Erbitux
A
Platinum + GemcitabineDRUG

Solution, IV, Gemcitabine given at 1250mg/m2 (Day 1 \& Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks, Maximum of 6 cycles = 18 weeks.

B

Eligibility Criteria

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

You may qualify if:

  • Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.
  • Must not have received cetuximab or any medications that target the same pathway as cetuximab (such as Iressa or Tarceva).
  • Must not have had hypersensitivity or severe allergic reactions to any monoclonal antibodies and must not have severe restrictive or interstitial lung disease.
  • Must be able to carry out work of light or sedentary nature (e.g. light house work, office work).
  • It must be at least 4 weeks since last major surgery or prior treatment with an investigational product and at least 12 weeks from any radiation therapy to the chest.

You may not qualify if:

  • Women who are pregnant or breastfeeding.
  • Women with a positive pregnancy test on enrollment or prior to study drug administration.
  • Any concurrent malignancy (subjects with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial).
  • Symptomatic or uncontrolled metastases in the central nervous system (CNS).
  • Peripheral neuropathy.
  • Inadequate hematologic function defined by an absolute neutrophil count (ANC) \<1,500/mm\^3, a platelet count \<100,000/mm\^3, or a hemoglobin level \< 9g/dL.
  • Inadequate liver function.
  • Inadequate kidney function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

Local Institution

Mobile, Alabama, United States

Location

Local Institution

Anchorage, Alaska, United States

Location

Local Institution

Bakersfield, California, United States

Location

Local Institution

Corona, California, United States

Location

Local Institution

Oxnard, California, United States

Location

Local Institution

San Diego, California, United States

Location

Local Institution

Whittier, California, United States

Location

Local Institution

Lakewood, Colorado, United States

Location

Local Institution

Boynton Beach, Florida, United States

Location

Local Institution

Brooksville, Florida, United States

Location

Local Institution

Inverness, Florida, United States

Location

Local Institution

Pembroke Pines, Florida, United States

Location

Local Institution

Austell, Georgia, United States

Location

Local Institution

Honolulu, Hawaii, United States

Location

Local Institution

Skokie, Illinois, United States

Location

Local Institution

Muncie, Indiana, United States

Location

Local Institution

Annapolis, Maryland, United States

Location

Local Institution

Frederick, Maryland, United States

Location

Local Institution

Rockville, Maryland, United States

Location

Local Institution

Plymouth, Massachusetts, United States

Location

Local Institution

Farmington, New Mexico, United States

Location

Local Institution

Armonk, New York, United States

Location

Local Institution

Stony Brook, New York, United States

Location

Local Institution

Gastonia, North Carolina, United States

Location

Local Institution

Wilmington, North Carolina, United States

Location

Local Institution

Bismarck, North Dakota, United States

Location

Local Institution

Cincinnati, Ohio, United States

Location

Local Institution

Portland, Oregon, United States

Location

Local Institution

Charleston, South Carolina, United States

Location

Local Institution

Dallas, Texas, United States

Location

Local Institution

Vancouver, Washington, United States

Location

Local Institution

Edmonton, Alberta, Canada

Location

Local Institution

Moncton, New Brunswick, Canada

Location

Local Institution

Hamilton, Ontario, Canada

Location

Local Institution

Montreal, Ontario, Canada

Location

Local Institution

Toronto, Ontario, Canada

Location

Local Institution

Windsor, Ontario, Canada

Location

Local Institution

Greenfield Park, Quebec, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

CetuximabPlatinumGemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetalsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2005

First Posted

June 2, 2005

Study Start

January 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

October 28, 2015

Record last verified: 2015-10

Locations

US(31)CA(7)