Vinorelbine Tartrate and Paclitaxel in Treating Older Patients With Advanced Non-Small Cell Lung Cancer
Condition: Recurrent Non-Small Cell Lung Carcinoma; Stage IV Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Paclitaxel; Quality-of-Life Assessment; Questionnaire Administration; Vinorelbine Tartrate
Intervention description: Given IV; Ancillary studies; Ancillary studies; Given IV
Intervention MeSH terms: Paclitaxel; Vinorelbine; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No

Summary:

      This phase II trial studies the side effects and how well vinorelbine tartrate and paclitaxel
      works in treating older patients with non-small cell lung cancer that has spread to other
      placed in the body. Drugs used in chemotherapy, such as vinorelbine tartrate and paclitaxel,
      work in different ways to stop the growth of tumor cells, either by killing the cells, by
      stopping them from dividing, or by stopping them from spreading. Giving combination
      chemotherapy may kill more tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically proven non-small cell lung cancer with evidence of distant
             metastases/malignant pleural effusion

          -  Measurable disease on imaging studies in 2 dimensions

          -  No previous therapy with either paclitaxel or vinorelbine, or any chemotherapy for the
             past five years

          -  Patients who have had a previous resection for their lung cancer and present with
             recurrent disease will be eligible

          -  Patients with other prior malignancies will be included, provided they have been
             disease-free for at least five years

          -  Patients with adequately treated basal cell or squamous cell carcinoma of the skin,
             adequately treated carcinoma in-situ of the cervix and hormone sensitive prostate
             cancer will be eligible

          -  Karnofsky score >= 70 (Eastern Cooperative Oncology Group [ECOG] 0-2)

          -  White blood cell (WBC) count >= 3,500/mm^3, OR

          -  Absolute neutrophil count (ANC) >= 1,500/ul

          -  Platelet count >= 100,000/mm^3

          -  Serum creatinine less than 1.5 times the upper limits of normal

          -  Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than
             1.5 times the upper limits of normal

          -  Serum alkaline phosphatase less than 2.5 times the upper limits of normal

          -  No active serious infections or other condition precluding chemotherapy

          -  Non-pregnant and non-nursing

          -  Men and women of reproductive potential may not participate unless they have agreed to
             use an effective contraceptive method while on the study

          -  Able to give informed consent

          -  Able to return for treatment and follow-up as specified in the protocol

        Exclusion Criteria:

          -  Known hypersensitivity to any component of vinorelbine or paclitaxel or other required
             drugs in the study

          -  Any comorbidity or condition which, in the opinion of the investigator, may interfere
             with the assessments and procedures of this protocol

          -  Inability to fulfill the requirements of the protocol