Docetaxel and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: cisplatin; docetaxel
Intervention MeSH terms: Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving docetaxel together with cisplatin
      works in treating patients with stage III or stage IV non-small cell lung cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed non-small cell lung cancer, meeting 1 of the
             following stage criteria:

               -  Stage IIIB disease with malignant pericardial or malignant pleural effusions, as
                  indicated by 1 of the following:

                    -  Positive cytology

                    -  Exudative effusion AND lactic dehydrogenase (LDH) > 200 IU with
                       effusion/serum LDH ratio ≥ 0.6

               -  Stage IV disease

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by
             conventional techniques OR > 10 mm by spiral CT scan

          -  Brain metastases allowed provided they have been irradiated AND are radiographically
             stable for ≥ 28 days after the completion of radiotherapy

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  At least 12 weeks

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 8.0 g/dL

        Hepatic

          -  AST and ALT normal

          -  Bilirubin normal

        Renal

          -  Creatinine clearance ≥ 50 mL/min

        Immunologic

          -  No known HIV positivity

          -  No history of severe hypersensitivity reaction to docetaxel or other drugs formulated
             with polysorbate 80

          -  No clinically significant active infection

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception before, during, and for 4 weeks
             after completion of study treatment

          -  No other primary malignancy within the past 5 years except adequately treated
             nonmelanoma skin cancer or carcinoma in situ of the cervix

          -  No other serious systemic disorder that would preclude study participation

          -  No other condition that would preclude study compliance

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Prior antibody-based therapy that targets growth factor pathways (e.g., epidermal
             growth factor receptor [EGFR]) allowed provided there is disease progression during
             therapy and patient has recovered

          -  No concurrent immunotherapy

          -  No concurrent prophylactic colony-stimulating factors

          -  No concurrent interleukin-11

        Chemotherapy

          -  No prior cytotoxic chemotherapy

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  No concurrent hormonal therapy for the malignancy

        Radiotherapy

          -  See Disease Characteristics

          -  More than 28 days since prior radiotherapy and recovered

          -  No prior radiotherapy to ≥ 25% of the bone marrow

          -  No prior radiotherapy to sites of measurable disease unless there is documented tumor
             progression after completion of radiotherapy

          -  No concurrent radiotherapy

        Surgery

          -  No concurrent surgery for the malignancy

        Other

          -  More than 3 weeks since prior investigational drugs

          -  Prior oral small molecule drug therapy that targets growth factor pathways (e.g.,
             EGFR) allowed provided there is disease progression during therapy and patient has
             recovered

          -  No other concurrent investigational or commercial agents or therapies for the
             malignancy