Tipifarnib Plus Radiation Therapy After Combination Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth and by making tumor cells more sensitive to radiation therapy.
      Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,
      such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells
      either by killing the cells or by stopping them from dividing and may also make tumor cells
      more sensitive to radiation therapy.

      PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib when
      given together with radiation therapy after combination chemotherapy in treating patients
      with stage III non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose and dose-limiting toxicity of tipifarnib given
           concurrently with radiotherapy after induction chemotherapy comprising paclitaxel and
           carboplatin and followed by maintenance therapy with tipifarnib in patients with stage
           IIIA or IIIB non-small cell lung cancer.

        -  Determine the tumor response at 3 months in patients treated with this regimen.

      OUTLINE: This is multicenter, dose-escalation study of tipifarnib.

      Patients receive induction chemotherapy comprising carboplatin IV over 30 minutes on day 1
      and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 2
      courses.

      Beginning 4-6 weeks after the completion of induction chemotherapy, patients receive oral
      tipifarnib twice daily for 7 weeks. Patients undergo radiotherapy once daily 5 days a week
      for 7 weeks beginning 3 days after the start of tipifarnib. After completion of radiotherapy,
      patients receive oral tipifarnib twice daily for 4 days and then once daily for 4 days.

      Cohorts of 3-6 patients receive escalating doses of tipifarnib while receiving radiotherapy
      until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
      preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

      Beginning 4-6 weeks after the completion of radiotherapy and tipifarnib, patients receive
      maintenance therapy comprising oral tipifarnib twice daily on days 1-21. Maintenance therapy
      repeats every 28 days in the absence of disease progression or unacceptable toxicity.

      Patients are followed at 3, 6, and 12 months.

      PROJECTED ACCRUAL: Approximately 9-12 patients will be accrued for this study within 1 year.
    

Intervention name(s): carboplatin; paclitaxel; tipifarnib; radiation therapy
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention MeSH terms: Paclitaxel; Carboplatin; Tipifarnib
Primary purpose: Treatment
Keywords: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer