NCT00003117 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Lamont EB, Herndon JE 2nd, Weeks JC, Henderson IC, Lilenbaum R, Schilsky RL, Christakis NA
Criterion validity of Medicare chemotherapy claims in Cancer and Leukemia Group B breast and lung cancer trial participants. J Natl Cancer Inst. 2005 Jul 20;97(14):1080-3.
Lamont EB, Herndon JE 2nd, Weeks JC, Henderson IC, Lilenbaum R, Schilsky RL, Christakis NA; Cancer and Leukemia Group B
Measuring clinically significant chemotherapy-related toxicities using Medicare claims from Cancer and Leukemia Group B (CALGB) trial participants. Med Care. 2008 Mar;46(3):303-8. doi: 10.1097/MLR.0b013e31815cecc3.
Lilenbaum RC, Herndon J, List M, et al
: Single-agent (SA) versus combination chemotherapy (CC) in advanced non-small cell lung cancer (NSCLC): a CALGB randomized trial of efficacy, quality of life (QOL), and cost-effectiveness. [Abstract] Proceedings of
Lilenbaum RC, Herndon JE 2nd, List MA, Desch C, Watson DM, Miller AA, Graziano SL, Perry MC, Saville W, Chahinian P, Weeks JC, Holland JC, Green MR
Single-agent versus combination chemotherapy in advanced non-small-cell lung cancer: the cancer and leukem

Single-Agent Versus Combination Chemotherapy in Advanced NSCLC: A CALGB Randomized Trial of Efficacy, Quality of Life, and Cost-Effectiveness

Clinical trial NCT00003117 - References