Expired Study
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Bakersfield, California


Purpose:

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.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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.


Study is Available At:


Original ID:

CA225-100


NCT ID:

NCT00112346


Secondary ID:


Study Acronym:


Brief Title:

Study of Gemcitabine/Platinum +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer


Official Title:

A Randomized Multicenter Phase II Study of Gemcitabine/Platinum/Cetuximab Versus Gemcitabine/Platinum as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Eli Lilly and Company


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

120


Enrollment Type:


Overall Contact Information

Official Name: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)
Study Director
Eli Lilly and Company

Study Dates

Start Date:January 2005
Completion Date:December 2006
Completion Type:Actual
Primary Completion Date:December 2006
Primary Completion Type:Actual
Verification Date:October 2015
Last Changed Date:October 26, 2015
First Received Date:June 1, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:disease control, symptom response, symptomatic progression, & progression free survival.
Safety Issues:False
Outcome Type:Primary Outcome
Measure:tumor response per treatment arm
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Cetuximab + platinum + gemcitabine
Description: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.
Arm Name:A
Other Name:Erbitux
Intervention Type:Drug
Name:Platinum + Gemcitabine
Description: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.
Arm Name:B

Study Arms

Study Arm Type:Active Comparator
Arm Name:A
Study Arm Type:Active Comparator
Arm Name:B

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Eli Lilly and Company
Agency Class:Industry
Agency Type:Collaborator
Agency Name:ImClone LLC

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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