Lung AdenocarcinomaPhase 1/2NCT00716456
Cetuximab in Patients With Lung Adenocarcinoma Receiving Erlotinib That Have Developed "Acquired Resistance" to Erlotinib
A Phase 1/2 study testing erlotinib with cetuximab in people with Lung Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
Trial summary
The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that initially became smaller after taking erlotinib and then started to get bigger despite continuing treatment. Cetuximab is a medicine approved by the U.S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Adenocarcinoma
- What is being tested?
- erlotinib with cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2008to May 2011
- Phase
- Phase 1/2
- 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
- Pathologic evidence of lung adenocarcinoma confirmed at MSKCC
- Measurable (RECIST) indicator lesions not previously irradiated
- Radiographic progression by RECIST during treatment with erlotinib
- Received treatment with erlotinib throughout the one month prior to enrollment
- Received treatment with erlotinib for >3 months
- At least one of the following:
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- Previously received treatment with erlotinib, gefitinib, or an investigational EGFR TK inhibitor (patients may have received other treatments subsequently including radiation or chemotherapy) and had a radiographic partial or complete response to treatment as defined by RECIST criteria
- A documented mutation in EGFR exons 19 or 21.
- Karnofsky performance status ≥ or = to 70%
- Total bilirubin: within normal institutional limits. AST/(SGOT)/ALT(SGPT)< or = to 2.5 X institutional upper limit of normal (ULN)
- Signed informed consent
- Effective contraception *
- Age > 18 years old *Sexually active women of childbearing potential must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control. All WOCBP MUST have a negative pregnancy test within two weeks prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study. In addition, all WOCBP should be instructed to contact the Investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation. The Investigator must immediately notify BMS in the event of a confirmed pregnancy in a patient participating in the study.
Who cannot join
- CNS lesions which are symptomatic and/or requiring escalating doses of corticosteroids.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Prior cetuximab or panitumumab. Prior severe infusion reaction to a monoclonal antibody.
- Current grade 2 or greater skin toxicity on erlotinib therapy
- Radiotherapy ≤ or = to 14 days prior to enrollment
- Any investigational agent or therapy ≤ or = to 30 days before enrollment
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- Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies (except erlotinib) ≤ or = to 30 days before enrollment
- Women who are pregnant or lactating.
- Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, acute or chronic active hepatitis B infection
- Major surgery within 28 days or minor surgery within 14 days of study enrollment
- Men or women of child-bearing potential (women who are post-menopausal < 52 weeks, not surgically sterilized, or not abstinent) not consenting to use adequate contraception (per institutional standard of care) during the course of the study and after the last investigational product(s) administration (24 weeks for women, 4 weeks for men)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, 11570
Memoral Sloan Kettering Cancer Center at Phelps
Sleepy Hollow, New York, 10591
About this study
Official title: A Phase I/II Trial of Cetuximab in Patients With Lung Adenocarcinoma Receiving Erlotinib That Have Developed "Acquired Resistance" to Erlotinib
The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that initially became smaller after taking erlotinib and then started to get bigger despite continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug administration for treatment of head and neck and colon cancer. The goal of the phase I portion of this trial is to find out the highest dose of cetuximab that can be taken together with erlotinib. This study will also give an idea of how well cetuximab shrinks lung cancer when given with erlotinib.
The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that initially became smaller after taking erlotinib or gefitinib and then started to get bigger despite continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug administration for treatment of head and neck and colon cancer. The goal of this phase is to determine if cetuximab given with erlotinib causes lung cancers to shrink in size.
- Conditions
- Lung Adenocarcinoma
- Being tested
- erlotinib with cetuximab
- Keywords
- MAB C225(CETUXIMAB)(ANTI-EGFR), OSI-774, TARCEVA (ERLOTINIB), Lung, Adenocarcinoma, Lung cancer
- Medical subject headings
- Adenocarcinoma of Lung, Adenocarcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erlotinib with cetuximabDrug
The phase I portion will accrue as many as 3 cohorts of 3-6 patients; receiving erlotinib 100 mg daily along with escalating doses of cetuximab administered every 2 weeks beginning at 250mg/m2 IV without a loading dose. Subsequent cetuximab dose levels will be 375 mg/m2, and 500 mg/m2, administered IV every 2 weeks. Patients will have baseline CT, labs and ECG done within 2 weeks of study entry. Three patients will be enrolled per dose level. Patients will be monitored for toxicity weekly for the first 5 weeks, and every 2 weeks thereafter. Patients will be monitored for response by CT in the fourth week of combined therapy and every 8 weeks. All patients in this portion of the trial will receive intravenous cetuximab every two weeks at the MTD (to be determined in phase I portion) and daily erlotinib on an outpatient basis and will obtain clinical re-evaluation and radiographic re-imaging on a schedule similar to that followed in the phase I portion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | In the phase I portion, patients will be enrolled in cohorts of 3-6 patients;receiving daily erlotinib 100 mg along with cetuximab given every 2 weeks beginning at 250mg/m2 IV. Following the initial dose, for dose levels 1 and 2 (250 mg/m2 and 375 mg/m2) patients will receive treatment every 2 weeks with cetuximab over 60 minutes. For dose level 3 (500 mg/m2) patients will receive treatment every 2 weeks with cetuximab over 120 minutes. The infusion rate of cetuximab should never exceed 10 mg/minute (5 mL/min). The dose may subsequently be reduced for individual patients, depending on a patient's toxicity. Receives: Drug: erlotinib with cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Maximum Tolerated Dose (MTD) of Cetuximab Given Every 2 Weeks
To determine the maximum tolerated dose (MTD) of cetuximab given every 2 weeks in patients with lung adenocarcinoma receiving erlotinib that have developed acquired resistance to erlotinib (phase I portion)
Measured: At conclusion of study, up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMay 2011
- Study completionMay 2011
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 Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 1/2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Gregory Riely, PhD, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716456
- Sponsor's protocol ID
- 08-055
- Status last verified
- Apr 2015
- First submitted
- 15 Jul 2008
- Last updated
- 30 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Cetuximab in Patients With Lung Adenocarcinoma Receiving Erlotinib That Have Developed "Acquired Resistance" to Erlotinib
- ClinicalTrials.gov ID
- NCT00716456
- Acronym / sponsor ID
- 08-055
- Conditions
- Lung Adenocarcinoma
- Keywords
- MAB C225(CETUXIMAB)(ANTI-EGFR), OSI-774, TARCEVA (ERLOTINIB), Lung, Adenocarcinoma, Lung cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jul 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Posted 30 Apr 2015
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 test if cetuximab (Erbitux) can shrink lung cancers that initially became smaller after taking erlotinib and then started to get bigger despite continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug administration for treatment of head and neck and colon cancer. The goal of the phase I portion of this trial is to find out the highest dose of cetuximab that can be taken together with erlotinib. This study will also give an idea of how well cetuximab shrinks lung cancer when given with erlotinib.
The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that initially became smaller after taking erlotinib or gefitinib and then started to get bigger despite continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug administration for treatment of head and neck and colon cancer. The goal of this phase is to determine if cetuximab given with erlotinib causes lung cancers to shrink in size.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: erlotinib with cetuximabIn the phase I portion, patients will be enrolled in cohorts of 3-6 patients;receiving daily erlotinib 100 mg along with cetuximab given every 2 weeks beginning at 250mg/m2 IV. Following the initial dose, for dose levels 1 and 2 (250 mg/m2 and 375 mg/m2) patients will receive treatment every 2 weeks with cetuximab over 60 minutes. For dose level 3 (500 mg/m2) patients will receive treatment every 2 weeks with cetuximab over 120 minutes. The infusion rate of cetuximab should never exceed 10 mg/minute (5 mL/min). The dose may subsequently be reduced for individual patients, depending on a patient's toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Pathologic evidence of lung adenocarcinoma confirmed at MSKCC
- Measurable (RECIST) indicator lesions not previously irradiated
- Radiographic progression by RECIST during treatment with erlotinib
- Received treatment with erlotinib throughout the one month prior to enrollment
- Received treatment with erlotinib for >3 months
Key exclusion criteria (11 listed)
- CNS lesions which are symptomatic and/or requiring escalating doses of corticosteroids.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Prior cetuximab or panitumumab. Prior severe infusion reaction to a monoclonal antibody.
- Current grade 2 or greater skin toxicity on erlotinib therapy
- Radiotherapy ≤ or = to 14 days prior to enrollment
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 |
|---|---|---|
| erlotinib with cetuximabThe phase I portion will accrue as many as 3 cohorts of 3-6 patients; receiving erlotinib 100 mg daily along with escalating doses of cetuximab administered every 2 weeks beginning at 250mg/m2 IV without a loading dose. Subsequent cetuximab dose levels will be 375 mg/m2, and 500 mg/m2, administered IV every 2 weeks. Patients will have baseline CT, labs and ECG done within 2 weeks of study entry. Three patients will be enrolled per dose level. Patients will be monitored for toxicity weekly for the first 5 weeks, and every 2 weeks thereafter. Patients will be monitored for response by CT in the fourth week of combined therapy and every 8 weeks. All patients in this portion of the trial will receive intravenous cetuximab every two weeks at the MTD (to be determined in phase I portion) and daily erlotinib on an outpatient basis and will obtain clinical re-evaluation and radiographic re-imaging on a schedule similar to that followed in the phase I portion | Drug | 1 |
Primary outcome
The Maximum Tolerated Dose (MTD) of Cetuximab Given Every 2 Weeks
Time frame: At conclusion of study, up to 24 weeks
To determine the maximum tolerated dose (MTD) of cetuximab given every 2 weeks in patients with lung adenocarcinoma receiving erlotinib that have developed acquired resistance to erlotinib (phase I portion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Gregory Riely, PhD, MD principal investigator
Memorial Sloan Kettering Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing erlotinib with cetuximab in people with Lung Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 5 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 13 inclusion and 11 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 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 30 Apr 2015). 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?
The Maximum Tolerated Dose (MTD) of Cetuximab Given Every 2 Weeks (time frame: At conclusion of study, up to 24 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 30 Apr 2015.