Status:
COMPLETED
Cetuximab in Patients With Lung Adenocarcinoma Receiving Erlotinib That Have Developed "Acquired Resistance" to Erlotinib
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Lung Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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. Ce...
Eligibility Criteria
Inclusion
- 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:
- 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.
Exclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00716456
Start Date
July 1 2008
End Date
May 1 2011
Last Update
April 30 2015
Active Locations (5)
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1
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
2
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
3
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
4
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, United States, 11570