2) The probability of toxicity is assumed to follows the beta distribution with 
a non-informative prior [Uniform (0,1)]. 
3) The trial will be terminated when the probability of toxicity is greater than 
the undesired level [defined in (1)] with a high confidence. In this design, 
we choose this confidence probability being 0.90. 
Under the above specification, the trial will be stopped when the Grade 3 
toxicity is observed in the following cases: (The number of toxicity is given in 
the numerator and the number of total cases in the denominator.) 2/2, 3/3, 
3/4-5, 4/6-7, 5/8-9, 6/10-12, 7/13-14. 
The trial can also be stopped when the Grade 4 toxicity is observed in: 1/1-2, 
2/3-6, 3/7-10, 4/11-14. 
11.0 REPORTING REQUIREMENTS 
11.1 Any life-threatening and/or unexpected and serious (grade 3 or 4) toxicity will 
be reported immediately to the Study Chairperson who, in turn, must notify the 
Surveillance Committee and the sponsoring agency. 
11.2 The Protocol Data management System will be used for data collections. 
12.0 REFERENCES 
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2. Bishop JM. Molecular themes in oncogenesis. Cell 1991; 64:235-248. 
3. Santos E, Nebreda AR. Structural and functional properties of ras proteins. FASEB 
1989; 3:2151-2163. 
4. Shimizu K, Birnbaum D, Ruly MA, et al. Structure of the ki-ras gene of the human lung 
carcinoma cell line calu-1. Nature 1983; 304:497-500. 
5. Rodenhuis S, Van De Wetering ML, Mooi WJ, Evers SG, Van Zandwijk N, Bos JL. 
Mutational activation of the K-ras oncogene. N Engl J Med 1987; 31 7; 15:929-935. 
6. Rodenhuis S, Slebos RJC, Boot AJM, et al. Incidence and possible clinical 
significance of K-ras oncogene activation in adenocarcinoma of the human lung. 
Cancer Res 1988; 48:5738-5741. 
7. Reynolds SH, Anna CK, Brown KC, et al. Activated protooncogenes in human lung 
tumors from smokers. Proc Natl Acad Sci USA 1991; 88:1085-1089. 
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