Carboplatin, Irinotecan, and Radiation Therapy Followed By Docetaxel in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as carboplatin, irinotecan, and docetaxel, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving
      combination chemotherapy together with radiation therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving carboplatin and irinotecan together
      with radiation therapy followed by docetaxel works in treating patients with newly diagnosed
      stage III non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the objective response rate in patients with newly diagnosed stage IIIA or
           IIIB non-small cell lung cancer treated with concurrent carboplatin, irinotecan
           hydrochloride, and radiotherapy followed by consolidation docetaxel.

      Secondary

        -  Evaluate the safety, toxicity, and complications of this regimen in these patients.

        -  Evaluate the median survival, 1-year and 2-year survival, and time to tumor progression
           in these patients.

      OUTLINE:

        -  Chemoradiotherapy: Patients receive carboplatin IV over 30 minutes followed by
           irinotecan hydrochloride IV over 90 minutes on day 1. Patients also undergo radiotherapy
           once daily on days 1-5. Treatment repeats weekly for up to 7 courses in the absence of
           disease progression or unacceptable toxicity.

        -  Consolidation chemotherapy: Beginning 3-4 weeks after completion of chemoradiotherapy,
           patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for
           up to 3 courses in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed periodically for 4 years and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
    

Intervention name(s): Carboplatin; Docetaxel; irinotecan hydrochloride; radiation therapy
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention description(s): CARBOPLATIN (AUC=2) IV in 250 cc NS over 30 minutes, weekly for seven weeks (Days #1, #8, #15, #22, #29, #36 and #43) along with radiation.; DOCETAXEL 75 mg/m2 IV over one hour every three weeks for 3 cycles.; IRINOTECAN 30 mg/m2 IV over 90 minutes weekly for seven weeks (Days #1, #8, #15, #22, #29, #36 and #43) along with radiation.; Radiotherapy will start on the first day of scheduled chemotherapy. The daily administered dose will be 1.8 Gy, 5 days a week for 4.4 weeks, 22 fractions, ( 39.6 Gy) to the primary tumor and mediastinum (primary planning target volume: PPTV). After 39.6 Gy, the same targets will be treated by oblique fields at 1.8 GY for 3 fxs to a toal dose of 45 GY. Thereafter, the primary tumor and involved nodal metastasis (secondary planning target volume SPTV) will be boosted at 2 Gy per day to 18 Gy in 9 fractions. The total dose will be 63 Gy in 35 fractions over seven weeks.
Intervention MeSH terms: Carboplatin; Docetaxel; Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer