Non Small Cell Lung Cancer (NSCLC)Phase 2NCT00492206
Study of Cetuximab With Radiation Followed by Consolidation Chemotherapy for NSCLC
A Phase 2 study testing Cetuximab in people with Non Small Cell Lung Cancer (NSCLC), run by University of Pittsburgh at 31 sites in United States.
Trial summary
This is an open label, phase II study in which cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab will be administered to subjects with locally advanced NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer (NSCLC)
- What is being tested?
- Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 31 sitesUnited States
- Study dates
- Jun 2006to Feb 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must have histologically or cytologically confirmed diagnosis of non-small cell lung cancer
- Patients must have surgically unresectable stage IIIA disease or stage IIIB disease without malignant pleural/pericardial effusion
- Patients must have measurable disease as per the RECIST criteria, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 9.2 for the evaluation of measurable disease.
- Age >18 years. Lung cancer is extremely rare in children.
- ECOG performance status 0-1 (Karnofsky >70%; see Appendix A).
- If available, tumor tissue should be submitted for EGFR status by IHC and correlative studies.
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- Patients must have normal organ and marrow function as defined below:
- leukocytes >3,000/μL
- absolute neutrophil count >1,500/μL
- platelets >100,000/μL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
- creatinine within normal institutional limits OR
- creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- The effects of cetuximab on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because EGFR inhibitors, chemotherapeutic agents and radiation therapy, as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Patients must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
- Willingness to sign an approved informed consent.
Who cannot join
- Patients should not have received prior chest radiation therapy.
- Patients with a history of pulmonary fibrosis are excluded from study.
- Patients may not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, paclitaxel, cetuximab or other agents used in the study.
- History of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last five years.
- Prior therapy with known specific inhibitors of the EGFR.
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- History of severe allergic reaction to prior therapy with monoclonal antibodies
- Peripheral neuropathy of more than grade 1 in severity
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, significant history of uncontrolled cardiac disease ie. uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure,and cardiomyopathy with decreased ejection fraction, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because carboplatin, paclitaxel, cetuximab and radiation therapy have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the above agents, breastfeeding should be discontinued if the mother is treated with the agents used in this study. These potential risks may also apply to other agents used in this study.
- Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with carboplatin, paclitaxel and cetuximab or other agents administered during the study. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
- Active hepatitis.
- History of pulmonary fibrosis.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Emory Winship Cancer Institute
Atlanta, Georgia, 30322
Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, 21231
UPMC Cancer Center -Beaver
Beaver, Pennsylvania, 15009
UPMC Cancer Center - Clairton
Clairton, Pennsylvania, 15025
UPMC Cancer Center - Oakbrook Commons
Greensburg, Pennsylvania, 15601
UPMC Cancer Center -Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601
Penn State Cancer Institute, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
UPMC Cancer Center -Indiana
Indiana, Pennsylvania, 15701
UPMC Cancer Center -John P. Murtha Pavilion
Johnstown, Pennsylvania, 15901
UPMC Cancer Center -McKeesport
McKeesport, Pennsylvania, 15132
Sylvester Comprehensive Cancer Center, University of Miami
Miami, Florida, 33136
UPMC Cancer Center -Haymaker Rd.
Monroeville, Pennsylvania, 15146
UPMC Cancer Center -Mosside Blvd.
Monroeville, Pennsylvania, 15146
UPMC Cancer Center -Sewickley Medical Center
Moon Township, Pennsylvania, 15108
UPMC Cancer Center -Mt. Pleasant
Mount Pleasant, Pennsylvania, 15666
UPMC Cancer Center -Jameson
New Castle, Pennsylvania, 16105
UPMC Cancer Center -New Castle
New Castle, Pennsylvania, 16105
UPMC Presbyterian -Radiation Oncology
Pittsburgh, Pennsylvania, 15213
UPMC Cancer Center -Delafield Rd.
Pittsburgh, Pennsylvania, 15215
UPMC Cancer Center -St. Margaret
Pittsburgh, Pennsylvania, 15215
Universtity of Pittsburgh Cancer Institute -Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
UPMC Cancer Center -UPMC Shadyside
Pittsburgh, Pennsylvania, 15232
UPMC Cancer Center -Passavant
Pittsburgh, Pennsylvania, 15237
UPMC Cancer Center -Drake
Pittsburgh, Pennsylvania, 15241
UPMC Cancer Center -St. Clair
Pittsburgh, Pennsylvania, 15243
UPMC Cancer Center -UPMC Northwest
Seneca, Pennsylvania, 16346
UPMC Cancer Center -Teramana Cancer Center
Steubenville, Ohio, 43952
UPMC Cancer Center -Robert Eberly Pavilion
Uniontown, Pennsylvania, 15401
UPMC Cancer Center -Uniontown
Uniontown, Pennsylvania, 15401
UPMC Cancer Center -Washington
Washington, Pennsylvania, 15301
UPMC Cancer Center -Wexford
Wexford, Pennsylvania, 15090
About this study
Official title: A Phase II Study of Cetuximab in Combination With External Beam Radiation Followed By Consolidation Chemotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
This is an open label, phase II study in which cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab will be administered to subjects with locally advanced NSCLC.
Read the detailed description
This is a Phase II study to determine the overall survival for patients with locally advanced NSCLC treated with cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab. This is a multicenter study including 36 subjects who will be males and females, both greater than 18 years of age. All subjects will initially receive radiation and cetuximab. Radiation will be given once a day (Monday-Friday) for approximately 6-8 weeks. During the course of radiation, cetuximab will be given intravenously once a week. Approximately 4-6 weeks after the last radiation dose, the subjects will be treated with chemotherapy, paclitaxel/carboplatin. Chemotherapy will be given intravenously once every 3 weeks for 3 cycles (1 cycle=3 weeks). Cetuximab intravenous administration will be continued throughout the entire study, once a week through week 26 including during chemotherapy.
- Conditions
- Non Small Cell Lung Cancer (NSCLC)
- Being tested
- Cetuximab
- Keywords
- Non Small Cell Lung Cancer, NSCLC, EGFR Inhibitor, Radiation Therapy
- 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
Also called Erbitux, C225
The initial dose of cetuximab is 400 mg/m2 intravenously administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes. Subjects will receive cetuximab from week 0 through week 26.
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab | Experimental | Cetuximab 400 mg/m2 IV week 0 only
External beam radiation weeks 1 - 7
Cetuximab 250 mg/m2 IV weekly thereafter weeks 1 - 7
Cetuximab 250 mg/m2 IV weekly weeks 8 - 26
Carboplatin AUC = 6 IV Paclitaxel 200 mg/m2 IV Every 3 weeks x 3 Cycles Receives: Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: Up to 36 months
Secondary outcomes (3)
Progression-free Survival (PFS)
Response and progression were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Progressive Disease was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Measured: Up to 36 months
Best Overall Response Rate (ORR) (Number of Participants)
The Best Overall Response is the best response (Complete Response, Partial Response, Stable Disease, Progressive Disease) recorded from the start of the study treatment until the disease progression/recurrence at end of study. Response and progression were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Complete Response (CR) is the Disappearance of all target lesions and Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Measured: Up to 12 weeks after treatment initiation
EGFR (Epidermal Growth Factor Receptor) Gene Mutation and Akt, pAkt, and MAPKinase
EGFR (epidermal growth factor receptor) gene mutation status and Akt, pAkt, and MAPKinase in participant tumor tissue.
Measured: approx. 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startJun 2006
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Ahmad Tarhini, University of Pittsburgh
- Investigators
- Athanassios Argiris, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492206
- Sponsor's protocol ID
- 05-106
- Other IDs
- NCT00492206
- Status last verified
- Dec 2016
- First submitted
- 26 Jun 2007
- Last updated
- 1 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Cetuximab in Combination With External Beam Radiation Followed By Consolidation Chemotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00492206
- Acronym / sponsor ID
- 05-106
- Conditions
- Non Small Cell Lung Cancer (NSCLC)
- Keywords
- Non Small Cell Lung Cancer, NSCLC, EGFR Inhibitor, Radiation Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jun 2006
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Jun 2007 (estimated)
- Results
- Posted 1 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, phase II study in which cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab will be administered to subjects with locally advanced NSCLC.
Detailed description
This is a Phase II study to determine the overall survival for patients with locally advanced NSCLC treated with cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab. This is a multicenter study including 36 subjects who will be males and females, both greater than 18 years of age. All subjects will initially receive radiation and cetuximab. Radiation will be given once a day (Monday-Friday) for approximately 6-8 weeks. During the course of radiation, cetuximab will be given intravenously once a week. Approximately 4-6 weeks after the last radiation dose, the subjects will be treated with chemotherapy, paclitaxel/carboplatin. Chemotherapy will be given intravenously once every 3 weeks for 3 cycles (1 cycle=3 weeks). Cetuximab intravenous administration will be continued throughout the entire study, once a week through week 26 including during chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cetuximab | Experimental | Drug: CetuximabCetuximab 400 mg/m2 IV week 0 only External beam radiation weeks 1 - 7 Cetuximab 250 mg/m2 IV weekly thereafter weeks 1 - 7 Cetuximab 250 mg/m2 IV weekly weeks 8 - 26 Carboplatin AUC = 6 IV Paclitaxel 200 mg/m2 IV Every 3 weeks x 3 Cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must have histologically or cytologically confirmed diagnosis of non-small cell lung cancer
- Patients must have surgically unresectable stage IIIA disease or stage IIIB disease without malignant pleural/pericardial effusion
- Patients must have measurable disease as per the RECIST criteria, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 9.2 for the evaluation of measurable disease.
- Age >18 years. Lung cancer is extremely rare in children.
- ECOG performance status 0-1 (Karnofsky >70%; see Appendix A).
Key exclusion criteria (13 listed)
- Patients should not have received prior chest radiation therapy.
- Patients with a history of pulmonary fibrosis are excluded from study.
- Patients may not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, paclitaxel, cetuximab or other agents used in the study.
- History of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last five 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 |
|---|---|---|
| CetuximabAlso: Erbitux, C225The initial dose of cetuximab is 400 mg/m2 intravenously administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes. Subjects will receive cetuximab from week 0 through week 26. | Drug | Cetuximab |
Primary outcome
Overall Survival (OS)
Time frame: Up to 36 months
3 secondary outcomes
Progression-free Survival (PFS)
Time frame: Up to 36 months
Best Overall Response Rate (ORR) (Number of Participants)
Time frame: Up to 12 weeks after treatment initiation
EGFR (Epidermal Growth Factor Receptor) Gene Mutation and Akt, pAkt, and MAPKinase
Time frame: approx. 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Athanassios Argiris, MD principal investigator
University of Pittsburgh
31 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 in people with Non Small Cell Lung Cancer (NSCLC), run by University of Pittsburgh at 31 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 17 inclusion and 13 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 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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?
Yes. Results are posted in the registry (first posted 1 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival (OS) (time frame: Up to 36 months). 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 1 Feb 2017.