Ph II Concurrent Chemo t/Docetaxel/Carboplatin/Radio Therapy-consolidation t/Locally Adv Inoperable Non-Small Cell Lung Cancer (NSCLC)
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Carboplatin; Docetaxel; radiation therapy
Intervention description: Carboplatin will be given weekly for seven weeks beginning on Day 1 of the study as a 30-minute intravenous infusion during concurrent therapy.
Carboplatin will be given once every three weeks as a 30-minute intravenous infusion immediately following the infusion of docetaxel. Patients will receive two cycles of consolidation treatment.; Docetaxel will be given weekly for seven weeks beginning on Day 1 of the study as a 30-minute intravenous infusion during concurrent therapy.
Docetaxel will be given once every three weeks administered as a one-hour IV infusion. Patients will receive two cycles of consolidation treatment (1 cycle = 3 weeks).; Radiotherapy will be administered daily X 5 day/week for 34 days beginning on Day 1 of the study. Radiotherapy will follow immediately after the infusions of docetaxel and carboplatin.
Intervention MeSH terms: Carboplatin; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Summary:

      RATIONALE: Because of its success in advanced NSCLC both as a single agent and in combination
      with other chemotherapeutics, it is reasonable to investigate the efficacy and toxicity of
      docetaxel as a multimodality regimen in this patient population. Docetaxel at a dose of 20
      mg/m2 appears to be a well-tolerated "weekly" dose when combined with either cisplatin 25
      mg/m2 20-22 or carboplatin area under the curve (AUC) 2 23-25 concomitant with radiation
      therapy.

      PURPOSE: To explore the potential benefits of the radiosensitizing effects of weekly
      docetaxel/carboplatin/radio therapy concurrent therapy followed full dose systemic
      docetaxel/carboplatin consolidation therapy on overall response rate, survival,
      progression-free survival, safety and toxicity in patients with locally advanced NSCLC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must voluntarily sign and date an informed consent before the initiation of
             any study procedures

          -  Patients must have non-metastatic, inoperable, Stage IIIA or IIIB histologically or
             cytologically documented NSCLC without evidence of malignant pleural effusion

          -  Patients must not have received any prior systemic chemotherapy, thoracic radiotherapy
             or surgical resection for treatment of NSCLC

          -  Patients must have at least one site of unidirectionally measurable disease

          -  Patients must be ≥ 3 weeks from a formal exploratory thoracotomy

          -  Patients must have a Radiation Oncology and Medical Oncology consult and approval
             prior to study entry

          -  Patients must be ≥ 18 years of age

          -  Women of childbearing potential must have a negative baseline serum pregnancy within 7
             days prior to Week 1, Day 1 and must not be breast feeding.

          -  Women of childbearing potential and men with a sexual partner of child bearing
             potential must use an effective method of contraception beginning prior to study
             entry, for the duration of the study participation and for a minimum of 3 months after
             the last dose of chemotherapy.

          -  Patients must have adequate hepatic, renal, lung and bone marrow function as defined
             below:

               -  Absolute neutrophil count (ANC) > 1,500/mm3

               -  Hemoglobin > 9.0 gm/dL

               -  Creatinine < 1.5

               -  Platelets > 100,000/mm3

               -  Total bilirubin within normal limits (WNL)

               -  AST or ALT and Alkaline Phosphatase must be within the range allowing for
                  eligibility, as per chart on page 10 of the protocol.

          -  Calculated CrCl > 50 ml/min (via Cockroft-Gault formula).

          -  Forced expiratory volume in 1 second (FEV 1) > 800 ml

        Exclusion Criteria:

          -  Known hypersensitivity to drugs formulated with polysorbate 80

          -  Peripheral neuropathy Grade ≥ 2.

          -  Wet stage IIIB (documented malignant pleural effusion) or stage IV NSCLC

          -  Previous chemotherapy or radiation therapy

          -  Any concomitant malignancy, brain metastasis or uncontrolled, clinically significant
             medical or psychiatric disorder

          -  Pregnant or nursing women

          -  A greater than or equal to 10% weight loss over the past 3 months