Erlotinib Hydrochloride With or Without Cixutumumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase I/II trial is studying the side effects and best dose of cixutumumab and to see how well erlotinib hydrochloride works when given together with or without cixutumumab in treating patients with stage III or stage IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether erlotinib hydrochloride is more effective when given together with or without cixutumumab in treating non-small cell lung cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Monoclonal; Enzyme Inhibitors; Erlotinib Hydrochloride; Immunoglobulins

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

• Stage IIIA, IIIB, or IV disease

• Mixed histology permitted provided small-cell elements are not present

• Measurable disease, defined as ≥ 1unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

• Must have failed ≥ 1 platinum-containing chemotherapy regimen

• CNS metastases are eligible if received prior radiotherapy to site(s) of CNS metastatic disease, or have had definitive resection of CNS metastatic disease and have no overt evidence of neurological deficits, are not requiring anti-epileptics, remain asymptomatic, and have been off steroids for ≥ 8 weeks

• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

• Life expectancy > 3 months

• Leukocytes ≥ 3,000/mm³

• Absolute neutrophil count ≥ 1,500/mm³

• Hemoglobin ≥ 9 g/dL

• Platelets ≥ 100,000/mm³

• Total bilirubin normal

• AST and ALT ≤ 2.5 times upper limit of normal (ULN)

• Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min

• Fasting serum glucose < 120 mg/dL OR normal

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to anti-IGF-1R recombinant monoclonal antibody IMC-A122 or erlotinib hydrochloride

• No poorly controlled diabetes mellitus

• Patients with a history of diabetes mellitus are eligible, provided their blood glucose is within normal range at screening and they are on a stable dietary or therapeutic regimen for this condition

• No uncontrolled intercurrent illness including, but not limited to, any of the following:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• Psychiatric illness or social situation that would limit compliance with study requirements

• No inability to take oral medications or, in the investigator's opinion, gastrointestinal conditions or abnormalities likely to influence the absorption of oral medications

• No prior or concurrent exposure to other EGFR or IGFR inhibitors

• Recovered from all prior therapy with acute effects resolved to ≤ grade 1

• At least 28 days since prior anticancer or investigational agent (within predicted 5 half-lives of agent)

• More than 4 weeks since prior radiotherapy to target lesions and documented disease progression at these sites

• More than 2 weeks since prior radiotherapy to non-target lesions

• More than 4 months since prior major surgery or hormonal therapy (other than replacement)