Pemetrexed or Docetaxel With or Without Erlotinib in Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib hydrochloride; pemetrexed disodium; docetaxel
Intervention description: Given orally once daily on days 2-19.; Given IV over 10 minutes on day 1; IV over 60 minutes on day 1.
Intervention MeSH terms: Docetaxel; Pemetrexed; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Summary:

      RATIONALE: Pemetrexed disodium and erlotinib hydrochloride may stop the growth of tumor cells
      by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as
      docetaxel, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. It is not yet known whether giving pemetrexed
      disodium or docetaxel together with erlotinib hydrochloride is more effective than giving
      pemetrexed disodium or docetaxel alone in treating non-small lung cancer.

      PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium or
      docetaxel together with or without erlotinib hydrochloride works in treating patients with
      stage IIIB or stage IV non-small cell lung cancer.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  Pathologic diagnosis of stage IIIB (with pleural effusion) or IV non-small cell lung
             cancer

          -  Progression following at least twelve weeks of treatment with single-agent erlotinib
             (or in combination with other experimental agents) during which time the patients
             experienced a clinical benefit as assessed by his/her treating physician and
             corroborated by radiographic assessment (at least one CT scan following at least 4
             weeks of erlotinib monotherapy demonstrating stable disease or response on erlotinib
             therapy).

          -  At least one measurable lesion as defined by modified Response Evaluation Criteria In
             Solid Tumors (RECIST) criteria

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

          -  Life expectancy of at least 12 weeks

          -  Absolute neutrophil count (ANC) >= 1.5x10(9)/L

          -  Platelet count >= 100x 10(9)

          -  Hemoglobin >= 8.0 g/dl

          -  Serum creatinine =< 1.5 upper limit of normal OR calculated creatinine clearance >= 45
             mL/min

          -  Total bilirubin =< 1.5 x upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN

          -  Available baseline diagnostic tumor specimen for correlative studies, any diagnostic
             material will be acceptable- paraffin block, cell block, fine needle aspirate etc.

          -  Patients must provide verbal and written informed consent to participate in the study

          -  Willingness and ability to comply with scheduled visits, treatment plans, laboratory
             tests, and other study procedures

          -  Patient must be able to take folic acid, vitamin B12 as well as dexamethasone therapy
             as per protocol guidelines

          -  Patient must be able to interrupt nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days
             before (5 days for long-acting NSAIDs), the day of, and 2 days following
             administration of pemetrexed (this exclusion criteria applies only to patients who
             have not received pemetrexed chemotherapy prior)

        EXCLUSION CRITERIA

          -  Active central nervous system disease (CNS) metastases, as indicated by clinical
             symptoms, cerebral edema or progressive growth (subjects with a clinical history of
             CNS metastases or cord compression are allowable if they have been definitively
             treated and are clinically stable for at least 4 weeks before first dose of study
             treatment for prior whole brain radiation and 2 weeks for prior gamma knife therapy)

          -  More than 1 prior cytotoxic chemotherapy regimen for relapsed or metastatic disease
             (not including erlotinib)

          -  Any prior epidermal growth factor receptor (EGFR) inhibitor therapy except for
             erlotinib

          -  Major surgery, chemotherapy, or investigational agents within 3 weeks of treatment day
             1 (except for erlotinib). Radiation therapy within 2 weeks of treatment day 1 (except
             for erlotinib).

          -  Prior treatment with both pemetrexed and docetaxel chemotherapy

          -  Pregnancy or breastfeeding or not receiving adequate contraception (including the
             patients spouse)

          -  Other severe acute or chronic medical or psychiatric conditions or laboratory
             abnormality that may increase the risk associated with study participation or study
             drug administration or may interfere with the interpretation of study results, and in
             the judgment of the investigator would make the patient inappropriate for entry into
             this study

          -  Patients who must receive pemetrexed and have the presence of third space fluid which
             cannot be controlled by drainage

          -  Patients who must receive docetaxel and who have peripheral neuropathy > grade 2

          -  Patients who must receive docetaxel and who have had a hypersensitivity reaction to
             medications formulated with polysorbate 80