CPT-11/Cisplatin and Celecoxib With Radiation Therapy for Patients With Unresectable Non-Small Cell Lung Cancer (NSCLC)
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objectives:

        -  To determine the feasibility, activity, and toxicity of a novel regimen using a
           concurrent irinotecan (CPT-11)/cisplatin and celecoxib combination for patients with
           unresectable NSCLC.

        -  To determine the maximal tolerance dose of celecoxib in patients with unresectable NSCLC
           treated with irinotecan/cisplatin and concurrent thoracic radiation therapy.

        -  To correlate the COX-2 expression and other biomarkers with response to the treatment in
           the tumor from a pretreatment biopsy specimen.
    

Detailed description: 
      Celecoxib is a non-steroidal-anti-inflammatory drug (NSAIDS), similar to aspirin or
      ibuprofen. Recent studies have shown that celecoxib has antitumor activity when used alone.
      It may also increase the tumor sensitivity to radiation, making tumors more responsive to
      radiation therapy.

      Before treatment starts, you will have a complete physical exam, including blood (about 2
      teaspoons) and urine tests. You will have a chest x-ray, CT/MRI scans, and/or a PET scan. You
      may have a bone scan (x-rays of your bones) if your doctor feels it is necessary. You may
      also have blood tests, x-rays, biopsy of the tumor, and any other tests which your physician
      feels are necessary for your standard of care.

      In this study, you will take celecoxib by mouth for 5 days before beginning radiation
      therapy. You will continue to receive celecoxib 7 days per week throughout radiation
      treatment (about 7 weeks). The amount of drug that you take will depend on what dose level
      you are assigned to. The dose levels are 200mg, 400mg, and 800 mg per day. Ten patients will
      be treated on each dose level starting at the lower level. You will be required to fill out a
      medication diary, documenting the dose of celecoxib you are taking and the time that you take
      it.

      You will receive cisplatin and CPT-11 by vein on Day 1 of Weeks 2 through 8. Chemotherapy
      will be given on an outpatient basis. CPT-11 will be infused by vein over 90 minutes followed
      by cisplatin which will be infused for 60 minutes. Because cisplatin can cause kidney damage,
      fluids may need to be injected to "flush" the kidneys. Diuretics are given by vein just
      before and after receiving cisplatin. So that the physician may better evaluate kidney
      function during this time, you may be asked to save urine specimens and to keep a record of
      all fluids taken by mouth during the first 24-48 hours after receiving cisplatin.

      Radiation therapy will begin on Day 1 of Week 2 and be given at the same time as
      chemotherapy. The radiation therapy treatments will be given once a day for 5 days a week,
      Monday-Friday. The total treatment time for individual patients will be decided by the
      physician, based on the your general condition and stage of disease. The length of the
      radiation treatment should be about 7 weeks (35 radiation treatments).

      During treatment, you will have blood tests (about 2 teaspoons) every week. You will report
      to your physician the degree of sore throat, difficulty swallowing, gastric burning, or any
      symptoms that concern you.

      You will be taken off study if the disease becomes worse or side effects become very severe.

      After treatment is completed, you will return for follow-up visits at one month, every 3
      months for 2 years, every 6 months for 3 to 5 years, then once a year for 10 years. At each
      follow-up visit, you will have blood (about 2 teaspoons) samples collected for routine lab
      tests and you will have a chest x-ray. You will have a CT scan of the chest every 6 months.
      Complete lung function tests will also be done. Lung function tests look at the exchange of
      the air flow, capacity of the lung, flexibility of the lung, and exchange of oxygen in carbon
      dioxide in the lungs.

      This is an investigational study. All of the drugs in this study are FDA approved and
      commercially available. The use of these drugs in combination is investigational. Between 30
      and 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
    

Intervention name(s): Celecoxib; Cisplatin; CPT-11; Concurrent Thoracic Radiation Therapy
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention description(s): 100 mg by mouth (PO) twice daily for 5 days before beginning radiation therapy; continued 7 days per week throughout radiation treatment (about 7 weeks).; 25 mg/m^2 IV over 60 minutes on Day 1, Weeks 2-8; 30 mg/m^2 IV over 90 minutes on Day 1, Weeks 2-8, followed by cisplatin which will be infused for 60 minutes.; 63 Gy at 1.8 Gy/Fx in 35 Fractions over 7 weeks starting 2nd week of celebrex.
Other intervention name(s): Celebrex; SC-58635; Platinol-AQ; Platinol; CDDP; Irinotecan; XRT; RT
Intervention MeSH terms: Celecoxib; Cisplatin; Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-Small Cell Lung Cancer; Lung Cancer; Celecoxib; Cisplatin; Platinol; CPT-11; Irinotecan; SC-58635; Celebrex; Radiation Therapy