Phase 2b Study of Cetuximab With Platinum-Based Chemo as First Line Treatment of Recurrent or Advanced NSCLC
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Cetuximab; Paclitaxel; Carboplatin; Gemcitabine; Cisplatin
Intervention description: Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.; Paclitaxel 200 mg/m2 Day 1 every 21 days; Carboplatin AUC 6 Day 1 every 21 days; Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days; Cisplatin 75 mg/m2 Day I every 21 days
Intervention MeSH terms: Paclitaxel; Carboplatin; Gemcitabine; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 601.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is testing the investigational drug, cetuximab, in combination with different
      chemotherapy drugs for lung cancer. The aim of the study is to determine which of the drug
      combinations looks most promising and should be tested further. The study will also look at
      what side effects may occur.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent before study-related activities

          -  Histologically or cytologically confirmed Stage IIIb with cytologically documented
             malignant pleural or pericardial effusion, Stage IV, or recurrent non-smal cell lung
             cancer (NSCLC) after resection or radiation for earlier stage disease

          -  Measurable or evaluable disease (per modified Response Evaluation Criteria in Solid
             Tumors [RECIST] guidelines)

          -  Male or female ≥ 18 years of age

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          -  White blood count ≥ 3 x 10(9)/L with neutrophils ≥ 1.5 x 10(9)/L, platelet count ≥ 100
             x 10(9)/L, and hemoglobin ≥ 9.5 g/dL

          -  Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5
             x ULN in patients with liver mets

          -  Serum creatinine ≤ 1.25 x ULN

          -  Recovery from prior surgery or radiation to Grade 1 or better toxicity

          -  Women of childbearing potential (WOCBP) and fertile men with partners of childbearing
             potential must be using an adequate method of contraception to avoid pregnancy
             throughout the study and for up to 4 wks after the study in such a manner that the
             risk of pregnancy is minimized

          -  WOCBP must have a negative serum or urine pregnancy test within 72 hrs prior to the
             start of study medication or in accordance with local regulations, whichever is of
             shorter duration

        Exclusion Criteria:

          -  WOCBP who are unwilling or unable to use an acceptable method of birth control to
             avoid pregnancy for the entire study period and for up to 4 weeks after the study

          -  Women who are pregnant or breastfeeding

          -  Women with a positive pregnancy test during screening or prior to study drug
             administration

          -  Sexually active fertile men not using effective birth control if their partners are
             women of child-bearing potential

          -  Prior chemo for advanced NSCLC; neoadjuvant or post-operative adjuvant chemo is
             allowed if completed at least 12 months before study entry

          -  Previous exposure to epidermal growth factor receptor (EGFR)-targeted therapy. Prior
             treatment with monoclonal antibodies targeting receptors other than the EGFR, such as
             bevacizumab, is allowed if completed > 30 days prior to randomization

          -  Treatment with any investigational agent(s) within 4 weeks prior to study entry

          -  Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, biologic or targeted
             therapy) other than protocol therapy

          -  Carcinoid, atypical carcinoid or small cell lung cancer

          -  Symptomatic or uncontrolled mets in the central nervous system

          -  Prior invasive malignancy requiring ongoing therapy within the past year

          -  Active infection (infection requiring intravenous [IV] antibiotics), including active
             tuberculosis, known and declared HIV

          -  Myocardial infarction within 6 months prior to study entry, uncontrolled congestive
             heart failure; or any current Grade 3 or 4 cardiovascular disorder despite treatment

          -  Known allergic/hypersensitivity reaction to any of the components of study treatments

          -  Peripheral neuropathy ≥ Grade 2, as assessed by Common Terminology Criteria for
             Adverse Events, version 3.0

          -  History of significant neurologic or psychiatric disorders including but not limited
             to dementia, seizures, and bipolar disorder

          -  Medical or psychological condition that would not permit the patient to complete the
             study or sign informed consent

          -  Known drug abuse

        Patients of all races and ethnic groups are eligible for this trial.