Lung NeoplasmsPhase 2NCT00768131
A Study to Determine Whether EGFR Status by FISH Can Predict Results in Non Small Cell Lung Cancer (NSCLC) Patients Treated With Cetuximab, Carboplatin and Paclitaxel
A Phase 2 study testing Cetuximab, Paclitaxel and Carboplatin in people with Lung Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Eli Lilly and Company at 14 sites in United States.
Trial summary
The purpose of this study is to determine if EGFR status (positive or negative) by FISH can predict response to cetuximab therapy in NSCLC patients treated with carboplatin and paclitaxel Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Cetuximab, Paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 14 sitesUnited States
- Study dates
- Oct 2008to Oct 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who present with Stage IV, Stage IIIB NSCLC or recurrent disease following radiation therapy or surgical resection
- No prior chemotherapy or anti-EGFR targeted therapy
- Sufficient tumor material for FISH testing
- Measurable disease (RECIST)
- ECOG performance status 0 or 1
Who cannot join
- Symptomatic or uncontrolled CNS metastases
- Inadequate hematologic function defined as ANC < 1,500/mm3, platelet count < 100,000/mm3, or a hemoglobin level < 9 g/dl
- Inadequate hepatic function defined as total bilirubin > 1.25 x ULN, AST level > 1.5 x ULN, or alkaline phosphatase > 5.0 x ULN
- Inadequate renal function defined by a serum creatinine level > 1.5 x ULN
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Local Institution
Annapolis, Maryland, 21401
Local Institution
Austin, Texas, 78705
Local Institution
Boynton Beach, Florida, 33435
Local Institution
Chicago, Illinois, 60612
Local Institution
Kalamazoo, Michigan, 49048
Local Institution
Little Rock, Arkansas, 72205
Local Institution
Long Beach, California, 90813
Local Institution
Louisville, Kentucky, 40207
Local Institution
Mount Sterling, Kentucky, 40353
Local Institution
Portland, Oregon, 97213
Local Institution
Skokie, Illinois, 60076
Local Institution
Staten Island, New York, 10310
Local Institution
Wichita, Kansas, 67214
Local Institution
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized Phase II Trial to Assess the Predictive Value of Increased EGFR Copy Number by FISH in Patients With Advanced / Metastatic NSCLC Treated With Cetuximab and Carboplatin / Paclitaxel
The purpose of this study is to determine if EGFR status (positive or negative) by FISH can predict response to cetuximab therapy in NSCLC patients treated with carboplatin and paclitaxel
- Conditions
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
- Being tested
- Cetuximab, Paclitaxel, Carboplatin
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux, BMS-564717
Vial, Intravenous, 400 mg/m² week 1 then 250 mg/m², Weekly, Until PD/Toxicity/Pt-PI Decision
PaclitaxelDrug
Vial, Intravenous, 225 mg/m2, Every 3 weeks, 6 cycles maximum
CarboplatinDrug
Vial, Intravenous, AUC = 6.0, Every 3 weeks, 6 cycles maximum
| Study group | Role | What they receive |
|---|---|---|
| A1 FISH (+) | Experimental | Not described Receives: Drug: Cetuximab; Drug: Paclitaxel; Drug: Carboplatin |
| B1 FISH (+) | Active comparator | Not described Receives: Drug: Paclitaxel; Drug: Carboplatin |
| A2 FISH (-) | Experimental | Not described Receives: Drug: Cetuximab; Drug: Paclitaxel; Drug: Carboplatin |
| B2 FISH (-) | Active comparator | Not described Receives: Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) will be compared for FISH positive subjects (subset) receiving paclitaxel / carboplatin +/- cetuximab
Measured: Every 6 weeks
Secondary outcomes (5)
Tumor response
Measured: Every 6 weeks
Disease control
Measured: Every 6 weeks
Overall survival (OS)
Measured: Every 4 months after subject off-treatment until 1 year after LPLT
Duration of Response
Measured: Every 6 weeks
Safety & exploratory biomarker analysis
Measured: Every 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768131
- Sponsor's protocol ID
- CA225-322
- Status last verified
- Oct 2015
- First submitted
- 6 Oct 2008
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial to Assess the Predictive Value of Increased EGFR Copy Number by FISH in Patients With Advanced / Metastatic NSCLC Treated With Cetuximab and Carboplatin / Paclitaxel
- ClinicalTrials.gov ID
- NCT00768131
- Acronym / sponsor ID
- CA225-322
- Conditions
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 7 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if EGFR status (positive or negative) by FISH can predict response to cetuximab therapy in NSCLC patients treated with carboplatin and paclitaxel
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1 FISH (+) | Experimental | Drug: Cetuximab, Drug: Paclitaxel, Drug: Carboplatin |
| B1 FISH (+) | Active comparator | Drug: Paclitaxel, Drug: Carboplatin |
| A2 FISH (-) | Experimental | Drug: Cetuximab, Drug: Paclitaxel, Drug: Carboplatin |
| B2 FISH (-) | Active comparator | Drug: Paclitaxel, Drug: Carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who present with Stage IV, Stage IIIB NSCLC or recurrent disease following radiation therapy or surgical resection
- No prior chemotherapy or anti-EGFR targeted therapy
- Sufficient tumor material for FISH testing
- Measurable disease (RECIST)
- ECOG performance status 0 or 1
Key exclusion criteria (4 listed)
- Symptomatic or uncontrolled CNS metastases
- Inadequate hematologic function defined as ANC < 1,500/mm3, platelet count < 100,000/mm3, or a hemoglobin level < 9 g/dl
- Inadequate hepatic function defined as total bilirubin > 1.25 x ULN, AST level > 1.5 x ULN, or alkaline phosphatase > 5.0 x ULN
- Inadequate renal function defined by a serum creatinine level > 1.5 x ULN
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetuximabAlso: Erbitux, BMS-564717Vial, Intravenous, 400 mg/m² week 1 then 250 mg/m², Weekly, Until PD/Toxicity/Pt-PI Decision | Drug | A1 FISH (+), A2 FISH (-) |
| PaclitaxelVial, Intravenous, 225 mg/m2, Every 3 weeks, 6 cycles maximum | Drug | A1 FISH (+), A2 FISH (-), B1 FISH (+), B2 FISH (-) |
| CarboplatinVial, Intravenous, AUC = 6.0, Every 3 weeks, 6 cycles maximum | Drug | A1 FISH (+), A2 FISH (-), B1 FISH (+), B2 FISH (-) |
Primary outcome
Progression Free Survival (PFS) will be compared for FISH positive subjects (subset) receiving paclitaxel / carboplatin +/- cetuximab
Time frame: Every 6 weeks
5 secondary outcomes
Tumor response
Time frame: Every 6 weeks
Disease control
Time frame: Every 6 weeks
Overall survival (OS)
Time frame: Every 4 months after subject off-treatment until 1 year after LPLT
Duration of Response
Time frame: Every 6 weeks
Safety & exploratory biomarker analysis
Time frame: Every 3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab, Paclitaxel and Carboplatin in people with Lung Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Eli Lilly and Company at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) will be compared for FISH positive subjects (subset) receiving paclitaxel / carboplatin +/- cetuximab (time frame: Every 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2015.