Erlotinib and Standard Platinum-Based Chemotherapy for Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms
Intervention: Erlotinib; Platinum-based chemotherapy
Intervention description: Erlotinib will be administered for at least 2 cycles (6 weeks) and for a maximum of 8 months.
Upon progression or intolerance to erlotinib, standard of care platinum-based chemotherapy (per the choice of the treating physician) is administered every 3 weeks. Physicians can adjust dose, schedule, or supportive care to the benefit of the patient; Intravenous chemotherapy combination per physician discretion every 3 weeks for at least 2 cycles
Intervention MeSH terms: Paclitaxel; Etoposide; Vinorelbine; Docetaxel; Gemcitabine; Irinotecan; Pemetrexed; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: erlotinib; NSCLC; chemotherapy; platinum; lung; lung cancer

Summary:

      This study was conducted to compare the activities of erlotinib to that of intravenous,
      platinum-based therapy in the treatment of non-small cell lung cancer (NSCLC). The goal of
      this trial was to demonstrate clinical equivalence of erlotinib to platinum-based frontline
      therapy, compared to historical controls.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior chemotherapy will be allowed for other invasive malignancies, provided at least
             five years has elapsed since the completion of therapy and enrollment on this
             protocol. No prior chemotherapy for metastatic non-small cell lung cancer (NSCLC) will
             be allowed. Prior adjuvant or neoadjuvant chemotherapy for NSCLC will be allowed,
             provided at least six months have elapsed from the last dose of chemotherapy to the
             documentation of relapsed disease.

        Baseline laboratory values (bone marrow, renal, hepatic):

          -  Adequate bone marrow function:

               -  Absolute neutrophil count >1000/µL

               -  Platelet count >100'000/µL

          -  Renal function:

               -  Serum creatinine < 2.0 mg %

          -  Hepatic function:

               -  Bilirubin <1.5x normal

               -  Serum calcium < 12 mg/dl

        Other Eligibility Criteria:

          -  Signed Informed Consent

          -  Eastern Cooperative Oncology Group (ECOG)/Zubrod/Southwest Oncology Group (SWOG)
             Performance Status <2 (Karnofsky Performance Status > 70%)

          -  Life expectancy > 8 weeks

          -  Male or female' age >18 years

          -  Patients of childbearing potential must be using an effective means of contraception.

          -  Histologic diagnosis of NSCLC that is advanced and cannot be treated adequately by
             radiotherapy or surgery; or metastatic disease

        Exclusion Criteria:

          -  Prior therapy with an epidermal growth factor receptor inhibitor, including erlotinib,
             gefitinib, and cetuximab, as well as any investigational HER-1 inhibiting agent

          -  Pregnant or lactating females

          -  Myocardial infarction or ischemia within the 6 months before Cycle 0' Day 0

          -  Uncontrolled' clinically significant dysrhythmia

          -  History of prior malignancy within the prior five years, with the exception of
             non-melanoma carcinomas of the skin, and carcinoma in situ of the cervix

          -  Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor
             growth in that lesion

          -  Uncontrolled metastatic disease of the central nervous system (previously treated,
             stable disease is allowable on this protocol)

          -  Radiotherapy within the 2 weeks before Cycle 1' Day 1

          -  Surgery within the 2 weeks before Cycle 1' Day 1

          -  Any co morbid condition that' in the view of the attending physician' renders the
             patient at high risk from treatment complications