Phase II Trial of Pulsed Taxol With Concurrent Thoracic Radiotherapy, & Adjuvant Chemo in Stage III NSCLC

This is a phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer

Sex

All

Minimum age

18 Years

Inclusion Criteria:

1. Patients must have: IIIA or IIIB non-small cell lung cancer by radiographic or surgical staging, excluding: superior sulcus tumors, tumors with associated atelectasis or obstructive pneumonitis of the entire lung, and tumors with a malignant pleural effusion.
2. Patients will be included in the study based on the following criteria:

   * Patients must be older than 18 years old.
   * Patients must have a Zubrod performance status of 0 to 2
   * Patients with adequate bone marrow function
   * Patients with adequate renal function
   * Patients with adequate hepatic function
   * Patients of childbearing potential must have a negative serum pregnancy test and use an effective form of contraception.
   * Patients who are suitable for treatment with radical intent using concurrent chemotherapy and radiation.
   * Patients who have signed an approved informed consent and authorization permitting release of personal health information.

Exclusion Criteria:

1. Disease-Specific Exclusions

   * Superior sulcus tumors
   * Atelectasis or obstructive pneumonitis of the entire lung
   * Malignant pleural effusion
2. General Medical Exclusions

   * Surgical candidates
   * Patients who are pregnant at the time of diagnosis
   * Serious concomitant systemic disorders incompatible with the study
   * Inability to comply with study and/or follow-up procedures
   * Life expectancy of less than 12 weeks
   * Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
   * Patients with septicemia or severe infection.
   * Patients who have circumstances that will not permit completion of this study or the required follow-up
   * Patients with any contraindication to gemcitabine, carboplatin, or paclitaxel

• BACKGROUNDTravis WD, Lubin J, Ries L, Devesa S. United States lung carcinoma incidence trends: declining for most histologic types among males, increasing among females. Cancer. 1996 Jun 15;77(12):2464-70. doi: 10.1002/(SICI)1097-0142(19960615)77:123.0.CO;2-M. PMID 8640694
• BACKGROUNDPisani P, Parkin DM, Ferlay J. Estimates of the worldwide mortality from eighteen major cancers in 1985. Implications for prevention and projections of future burden. Int J Cancer. 1993 Dec 2;55(6):891-903. doi: 10.1002/ijc.2910550604. PMID 8253525
• BACKGROUNDJemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ. Cancer statistics, 2006. CA Cancer J Clin. 2006 Mar-Apr;56(2):106-30. doi: 10.3322/canjclin.56.2.106. PMID 16514137
• BACKGROUNDPeto R, Lopez AD, Boreham J, Thun M, Heath C Jr. Mortality from tobacco in developed countries: indirect estimation from national vital statistics. Lancet. 1992 May 23;339(8804):1268-78. doi: 10.1016/0140-6736(92)91600-d. PMID 1349675
• BACKGROUNDHoffman PC, Mauer AM, Vokes EE. Lung cancer. Lancet. 2000 Feb 5;355(9202):479-85. doi: 10.1016/S0140-6736(00)82038-3. PMID 10841143
• BACKGROUNDJemal A, Murray T, Samuels A, Ghafoor A, Ward E, Thun MJ. Cancer statistics, 2003. CA Cancer J Clin. 2003 Jan-Feb;53(1):5-26. doi: 10.3322/canjclin.53.1.5. PMID 12568441
• BACKGROUNDOnishi H, Araki T, Shirato H, Nagata Y, Hiraoka M, Gomi K, Yamashita T, Niibe Y, Karasawa K, Hayakawa K, Takai Y, Kimura T, Hirokawa Y, Takeda A, Ouchi A, Hareyama M, Kokubo M, Hara R, Itami J, Yamada K. Stereotactic hypofractionated high-dose irradiation for stage I nonsmall cell lung carcinoma: clinical outcomes in 245 subjects in a Japanese multiinstitutional study. Cancer. 2004 Oct 1;101(7):1623-31. doi: 10.1002/cncr.20539. PMID 15378503