Carcinoma, Non-Small-Cell LungPhase 2NCT00251498
Phase II Study of Cetuximab in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing Cetuximab in people with Carcinoma, Non-Small-Cell Lung, run by Veeda Oncology at 1 site in United States.
Trial summary
The primary objective of this study is to determine the efficacy (response rate) of cetuximab when administered in combination with docetaxel and carboplatin for treatment of patients with advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Cetuximab
- Type of treatment
- Injection or infusion
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Oct 2007
- 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
- Adult, Older adult
Who may be able to join
- Histologically/cytologically confirmed stage IIIB (pleural or pericardial effusion) or stage IV NSCLC.
- Age > 18 years.
- ECOG PS 0-1.
- No prior chemotherapy for NSCLC.
- Measurable disease by RECIST criteria.
- Signed IRB-approved informed consent.
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- Adequate bone marrow function defined by: peripheral absolute neutrophil count (ANC) >1500/microL, hemoglobin >9.0 g/dL, and platelet count >100,000/microL.
- Adequate renal function as defined by serum creatinine level less than institutional upper limit of normal (ULN) or calculated/measured creatinine clearance > 65 mL/min.
- Adequate liver function defined as: serum total bilirubin <ULN, serum aspartate aminotransferase (AST) <2.5 times ULN.
- Estimated life expectancy >12 weeks.
Who cannot join
- Untreated clinically active brain metastasis.
- Radiotherapy within 2 weeks prior to registration or previous irradiation to the only area of measurable disease.
- Treatment with any investigational therapy within 4 weeks prior to registration.
- Prior therapy with an agent that is known to specifically and directly target the EGFR pathway.
- History of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last 5 years.
- Patients in their reproductive age group should consent to use an effective method of birth control while on treatment and for at least 3 months thereafter. Patients who are breast-feeding, or have a positive pregnancy test will be excluded from the study.
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- Major surgery within 3 weeks prior to registration.
- Use of immunosuppressive agents including systemic corticosteroids within 4 weeks prior to registration (corticosteroids are permitted as physiological replacement therapy or as supportive care for nausea and emesis).
- Known history of human immunodeficiency virus infection.
- Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator.
- Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
- Concurrent serious infection.
- History of known hypersensitivity to docetaxel or other drugs formulated with polysorbate 80.
- History of prior severe infusion reaction to a monoclonal antibody.
- Patient has >Grade 2 peripheral neuropathy within 14 days prior to registration
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to determine the efficacy (response rate) of cetuximab when administered in combination with docetaxel and carboplatin for treatment of patients with advanced non-small cell lung cancer.
The secondary objectives of this study are:
Read more
- to determine the time to progression and overall survival for patients with advanced NSCLC who are treated with the combination docetaxel, carboplatin , and cetuximab
- to determine the toxicity of the combination in patients with advanced NSCLC.
Patients with stages IIIB (pleural or pericardial effusion) and IV NSCLC who have not received any prior chemotherapy will be eligible to participate in the trial. Other eligibility criteria include: ECOG PS 0-1, normal hepatic and renal function, age >18 years. Specific inclusion and exclusion criteria are detailed in Sections 4.2 and 4.3.
Read the detailed description
This is a phase II, open label, non-randomized study in patients with histologically/cytologically confirmed stage IIIB (pleural or pericardial effusion) or stage IV NSCLC who have not received prior chemotherapy. The trial will evaluate the efficacy and safety profile of the combination of docetaxel, carboplatin and cetuximab for patients with advanced NSCLC.
Patients will receive a combination of docetaxel and carboplatin administered every 3 weeks plus cetuximab given weekly. A maximum of four cycles of chemotherapy will be administered to patients. Patients who demonstrate an ongoing response (CR/PR/SD) at the end of 4th cycle of chemotherapy, may receive two more cycles of treatment. Patients who continue to respond (CR/PR/SD) after six cycles of therapy may receive therapy with single agent cetuximab (250 mg/m2/week) for up to 1 year or until disease progression or unacceptable toxicity, whichever occurs first.
Patients will be evaluated for response, time to progression, and overall survival. In addition, the safety profile of the combination will be assessed.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Cetuximab
- Keywords
- Metastatic 1st line NSCLC
- Medical subject headings
- 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
Cycle 1:400 mg/m2, administered as a 120-minute iv infusion on Day 1 and 250 mg/m2 administered as a 60-minute iv infusion on Days 8 and 15, subsequent cycles:250 mg/m2 administered as a 60-minute iv infusion on Days 1, 8, 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2005 (estimated)
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veeda Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Chandra Belani, MD, Principal investigator, Veeda Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251498
- Sponsor's protocol ID
- I-04-002
- Status last verified
- Aug 2008
- First submitted
- 8 Nov 2005
- Last updated
- 21 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Cetuximab in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00251498
- Acronym / sponsor ID
- I-04-002
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Metastatic 1st line NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Veeda OncologyUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study completion
- Oct 2007 (actual)
- First posted
- 10 Nov 2005 (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 primary objective of this study is to determine the efficacy (response rate) of cetuximab when administered in combination with docetaxel and carboplatin for treatment of patients with advanced non-small cell lung cancer.
The secondary objectives of this study are:
- to determine the time to progression and overall survival for patients with advanced NSCLC who are treated with the combination docetaxel, carboplatin , and cetuximab
- to determine the toxicity of the combination in patients with advanced NSCLC.
Patients with stages IIIB (pleural or pericardial effusion) and IV NSCLC who have not received any prior chemotherapy will be eligible to participate in the trial. Other eligibility criteria include: ECOG PS 0-1, normal hepatic and renal function, age >18 years. Specific inclusion and exclusion criteria are detailed in Sections 4.2 and 4.3.
Detailed description
This is a phase II, open label, non-randomized study in patients with histologically/cytologically confirmed stage IIIB (pleural or pericardial effusion) or stage IV NSCLC who have not received prior chemotherapy. The trial will evaluate the efficacy and safety profile of the combination of docetaxel, carboplatin and cetuximab for patients with advanced NSCLC.
Patients will receive a combination of docetaxel and carboplatin administered every 3 weeks plus cetuximab given weekly. A maximum of four cycles of chemotherapy will be administered to patients. Patients who demonstrate an ongoing response (CR/PR/SD) at the end of 4th cycle of chemotherapy, may receive two more cycles of treatment. Patients who continue to respond (CR/PR/SD) after six cycles of therapy may receive therapy with single agent cetuximab (250 mg/m2/week) for up to 1 year or until disease progression or unacceptable toxicity, whichever occurs first.
Patients will be evaluated for response, time to progression, and overall survival. In addition, the safety profile of the combination will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically/cytologically confirmed stage IIIB (pleural or pericardial effusion) or stage IV NSCLC.
- Age > 18 years.
- ECOG PS 0-1.
- No prior chemotherapy for NSCLC.
- Measurable disease by RECIST criteria.
Key exclusion criteria (15 listed)
- Untreated clinically active brain metastasis.
- Radiotherapy within 2 weeks prior to registration or previous irradiation to the only area of measurable disease.
- Treatment with any investigational therapy within 4 weeks prior to registration.
- Prior therapy with an agent that is known to specifically and directly target the EGFR pathway.
- History of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last 5 years.
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 |
|---|---|---|
| CetuximabCycle 1:400 mg/m2, administered as a 120-minute iv infusion on Day 1 and 250 mg/m2 administered as a 60-minute iv infusion on Days 8 and 15, subsequent cycles:250 mg/m2 administered as a 60-minute iv infusion on Days 1, 8, 15 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2008.
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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.
Chandra Belani, MD principal investigator
Veeda Oncology
1 site 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 in people with Carcinoma, Non-Small-Cell Lung, run by Veeda Oncology at 1 site 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 10 inclusion and 15 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: finished, as of the sponsor's last update on 21 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 21 Aug 2008.