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A Phase I/II Trial of Cetuximab in Patients With Lung Adenocarcinoma Receiving Erlotinib That Have Developed "Acquired Resistance" to Erlotinib

Phase 1/Phase 2
18 Years
Not Enrolling
Lung Adenocarcinoma

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Trial Information

A Phase I/II Trial of Cetuximab in Patients With Lung Adenocarcinoma Receiving Erlotinib That Have Developed "Acquired Resistance" to Erlotinib

Inclusion Criteria:

- 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

Exclusion Criteria:

- CNS lesions which are symptomatic and/or requiring escalating doses of

- 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

- 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)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Time Frame:

conclusion of study

Safety Issue:


Principal Investigator

Gregory Riely, PhD, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2008

Completion Date:

May 2011

Related Keywords:

  • Lung Adenocarcinoma
  • Lung
  • LUNG
  • Adenocarcinoma
  • Lung cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Lung Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center Rockville Centre, New York  11570
Memoral Sloan Kettering Cancer Center Basking Ridge, New Jersey  
Memorial Sloan-Kettering Cancer Center @ Suffolk Commack, New York  11725
Memoral Sloan Kettering Cancer Center at Phelps Sleepy Hollow, New York  10591