Carboplatin and Paclitaxel Combined With Cetuximab and/or IMC-A12 in Patients With Advanced Non-Small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

In brief

This randomized phase II trial is studying how well giving carboplatin and paclitaxel together with cetuximab and/or cixutumumab (IMC-A12) works in treating patients with stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and 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. Giving chemotherapy together with monoclonal antibody therapy may kill more tumor cells. It is not yet known whether carboplatin and paclitaxel are more effective when given with cetuximab and/or cixutumumab in treating non-small cell lung cancer.

Key facts

Study ID

NCT00986674

Run by

National Cancer Institute (NCI)

People needed

140

Starts

2009-09-01

Expected to finish

2013-12-01

Last updated by the study team

2014-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
• Stage IIIB disease
• T4, NX with nodule in ipsilateral lung lobe allowed provided patient is not a candidate for combined chemotherapy and radiotherapy
• Stage IV disease (includes M1a and M1b)
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
• Ineligible for or refused treatment with bevacizumab
• No untreated or symptomatic central nervous system (CNS) metastases
• Patients with a history of CNS metastases that are definitively treated, stable, and controlled are eligible provided the following criteria are met:
• Definitive therapy (surgery and/or radiotherapy) has been administered
• Not planning to undergo additional treatment for brain metastases
• Clinically stable
• Off corticosteroids or on a stable dose of corticosteroids for ≥ 14 days before study entry
• ECOG performance status 0-1
• Leukocytes > 3,000/mm\^3
• Absolute neutrophil count (ANC) > 1,500/mm\^3
• Hemoglobin > 9 g/dL
• Platelet count > 100,000/mm\^3
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Aspartate Aminotransferase (AST) < 3 times ULN (< 5 times ULN if elevations due to liver metastases)
• Creatinine < 1.5 times ULN OR creatinine clearance > 60 mL/min
• Fasting serum glucose < 120 mg/dL
• Partial thromboplastin time (PTT) ≤ 1.2 times ULN and international normalized ratio (INR) ≤ 1.5 (unless patient is on anticoagulation therapy)
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after the last dose of cixutumumab
• No poorly controlled diabetes mellitus

You may not qualify if…

• Small cell lung cancer or mixed small cell and NSCLC
• History of allergic reactions attributed to compounds of similar chemical or biological composition to cixutumumab
• History of any medical or psychiatric condition, addictive disorder, or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with study participation or study treatments or may interfere with the conduct of the study or interpretation of study results
• Prior agents targeting the EGFR or Insulin-like growth factor (IGFR) pathways
• Prior therapy for advanced NSCLC, except for surgery and/or radiotherapy
• Prior systemic therapy, including bevacizumab for advanced stage NSCLC
• Pregnant or nursing
• Peripheral neuropathy > grade 1 as per Common Terminology Criteria for Adverse Event (CTCAE) v 4.0
• History of or suspected interstitial pneumonitis or pulmonary fibrosis on imaging
• Significant uncontrolled cardiac disease within the past 6 months, including any of the following:
• Uncontrolled hypertension (BP > 150/100 mm Hg)
• Unstable angina
• Recent myocardial infarction
• Uncontrolled congestive heart failure
• Cardiomyopathy with decreased ejection fraction
• Arterial thrombosis, pulmonary embolus, deep vein thrombosis, or hemorrhagic disorders within the past 28 days

Where it is running

• The Medical Center of Aurora — Aurora, Colorado, United States
• Boulder Community Hospital — Boulder, Colorado, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Exempla Saint Joseph Hospital — Denver, Colorado, United States
• Presbyterian - Saint Lukes Medical Center - Health One — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• Colorado Cancer Research Program CCOP — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Saint Mary's Hospital and Regional Medical Center — Grand Junction, Colorado, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• Saint Anthony Hospital — Lakewood, Colorado, United States
• Sky Ridge Medical Center — Lone Tree, Colorado, United States
• Longmont United Hospital — Longmont, Colorado, United States
• McKee Medical Center — Loveland, Colorado, United States
• Saint Mary Corwin Medical Center — Pueblo, Colorado, United States
• North Suburban Medical Center — Thornton, Colorado, United States
• Exempla Lutheran Medical Center — Wheat Ridge, Colorado, United States
• Danbury Hospital — Danbury, Connecticut, United States
• Saint Francis Hospital and Medical Center — Hartford, Connecticut, United States
• Manchester Memorial Hospital — Manchester, Connecticut, United States
• Medical Center of Central Georgia — Macon, Georgia, United States
• Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
• Saint Joseph Medical Center — Bloomington, Illinois, United States
• Stanford University Hospitals and Clinics — Stanford, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.