Phase I study of a five-day dose schedule of 4-ipomeanol in patients with non-small cell lung cancer

Clinical Cancer Research

Volumn 4, Issue 9, 1998, Pages 2095-2102

  Kasturi, Vijay K ^a   Dearing, Mary Patrick ^a,f   Piscitelli, Stephen C ^b   Russell, Edward K ^a   Sladek, Gary G ^d   O'Neil, Kevin ^d   Turner, Gregory A ^e   Morton, Terri L ^e   Christian, Michaele C ^c   Johnson, Bruce E ^a   Kelley, Michael J ^a,g  

^a Vascular Medicine Branch   (United States)

^b Clinical Center Pharmacy Department   (United States)

^c Cancer Therapy Evaluation Program   (United States)

^d NATIONAL CANCER INSTITUTE   (United States)

^e MIDWEST RESEARCH INSTITUTE   (United States)

^f NONE   (United States)

^g WALTER REED ARMY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

4 IPOMEANOL; CYTOCHROME P450;

ADULT; AGED; AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; BLOOD TOXICITY; CANCER CLASSIFICATION; CLARA CELL; CLINICAL ARTICLE; CLINICAL TRIAL; CYTOTOXICITY; DRUG ACTIVITY; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG SENSITIVITY; DRUG URINE LEVEL; FEMALE; GASTROINTESTINAL TOXICITY; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; LIVER TOXICITY; LUNG NON SMALL CELL CANCER; MALE; NEPHROTOXICITY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RESPIRATORY TRACT DISEASE;

ADULT; AGED; ANTINEOPLASTIC AGENTS; CARCINOMA, NON-SMALL-CELL LUNG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; LUNG DISEASES; LUNG NEOPLASMS; MALE; MIDDLE AGED; PARTIAL THROMBOPLASTIN TIME; TERPENES;

EID: 0031720065     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (40)

1. Parker, S., Tong, T., Bolden, S., and Wingo, P. Cancer statistics, 1997. CA Cancer J. Clin., 47: 5-27, 1997.
2. Driscoll, J. The preclinical new drug research program of the National Cancer Institute. Cancer Treat. Rep., 68: 63-76, 1984.
3. Shoemaker, R., Wolpert-DeFilippes, M., Kern, D., Lieber, M., Makuch, R., Melnick, N., Miller, W., Salmon, S., Simon, R., Venditti, J., and Von Hoff, D. Application of a human tumor colony-forming assay to new drug screening. Cancer Res., 45: 2145-2153, 1985.
4. Rigas, J., Tong, W., Kris, M., Orazem, J., Young, C., and Warrell, R. J. Phase I clinical and pharmacological study of chloroquinoxaline sulfonamide. Cancer Res., 52: 6619-6623, 1992.
5. Johnson, B., Parker, R., Tsai, C., Baltz, J., Miller, M., Shoemaker, R., Phelps, R., Bastian, A., Stocker, J., and Phares, J. Phase I trial of dihydrolenperone in lung cancer patients: a novel compound with in vitro activity against lung cancer. Investig. New Drugs, 11: 29-37, 1993.
6. Rubinstein, L., Shoemaker, R., Paull, K., Simon, R., Tosini, S., Skehan, P., Scudiero, D., Monks, A., and Boyd, M. Comparison of in vitro anticancer-drug-screening data generated with a tetrazolium assay versus a protein assay against a diverse panel of human tumor cell lines. J. Natl. Cancer Inst., 82: 1113-1118, 1990.
7. Monks, A., Scudiero, D., Skehan, P., Shoemaker, R., Paull, K., Vistica, D., Hose, C., Langley, J., and Cronise, P. Feasibility of a high-flux anticancer drug screen using a diverse panel of cultured human tumor cell lines. J. Natl. Cancer Inst., 83: 757-766, 1991.
8. Shoemaker, R., Monks, A., Alley, M., Scudiero, D., Fine, D., McLemore, T., Abbott, B., Paull, K., Mayo, J., and Boyd, M. Development of human tumor cell line panels for use in disease-oriented drug screening. Prog. Clin. Biol. Res., 276: 265-286, 1988.
9. Boyd, M., and Wilson, B. Isolation and characterization of 4-ipomeanol, a lung-toxic furanoterpenoid produced by sweet potatoes (Ipomoea batatas). J. Agric. Food Chem., 20: 428-430, 1972.
10. Boyd, M., Wilson, B., and Harris, T. Confirmation by chemical synthesis of the structure of 4-ipomeanol, a lung-toxic metabolite of the sweet potato, Ipomoea batatas. Nat. New Biol., 236: 158-159, 1972.
11. Boyd, M., Burka, L., Harris, T., and Wilson, B. Lung-toxic furanoterpenoids produced by sweet potatoes following microbial infection. Biochim. Biophys. Acta, 337: 184-195, 1974.
12. Boyd, M. Evidence for the Clara cell as a site of cytochrome P450-dependent mixed-function oxidase activity in lung. Nature (Lond.), 269: 713-715, 1977.
13. Boyd, M., Dutcher, J., Buckpitt, A., Jones, R., and Statham, C. Role of metabolic activation of extrahepatic target organ alkylation and cytotoxicity by 4-ipomeanol, a furan derivative from moldy sweet potatoes: possible implications for carcinogenesis. In: E. C. Miller (ed.), Naturally Occurring Carcinogens: Mutagens and Modulators of Carcinogenesis, pp. 35-56. Baltimore, MD: University Park Press, 1979.
14. Boyd, M., and Reznik-Schuller, H. Metabolic basis for the pulmonary Clara cell as a target for pulmonary carcinogenesis. Toxicol. Pathol., 12: 56-61, 1984.
15. Boyd, M., Burka, L., Wilson, B., and Sasame, H. In vitro studies on the metabolic activation of the pulmonary toxin, 4-ipomeanol, by rat lung and liver microsomes. J. Pharmacol. Exp. Ther., 207: 677-686, 1978.
16. Ravindranath, V., Burka, L., and Boyd, M. Reactive metabolites from the bioactivation of toxic methylfurans. Science (Washington DC), 224: 884-886, 1984.
17. Christian, M., Wittes, R., Leyland-Jones, B., McLemore, T., Smith, A., Grieshaber, C., Chabner, B., and Boyd, M. 4-Ipomeanol: a novel investigational new drug for lung cancer. J. Natl. Cancer Inst., 81: 1133-1143, 1989.
18. Boyd, M. Metabolic activation as a basis for organ-selective toxicity. Clin. Exp. Pharmacol. Physiol., 10: 87-107, 1983.
19. Falzon, M., McMahon, J., Schuller, H., and Boyd, M. Metabolic activation and cytotoxicity of 4-ipomeanol in human non-small cell lung cancer lines. Cancer Res., 46: 3484-3489, 1986.
20. Smith, A., Barrett, D., Stedham, M., El-Hawari, M., Kastello, M., Grieshaber, C., and Boyd, M. Preclinical toxicology studies of 4-ipomeanol: a novel candidate for clinical evaluation in lung cancer. Cancer Treat. Rep., 71: 1157-1164, 1987.
21. Boyd, M., and Dutcher, J. Renal toxicity due to reactive metabolites formed in situ in the kidney: investigations with 4-ipomeanol in the mouse. J. Pharmacol. Exp. Ther., 216: 640-646, 1981.
22. 14C]4-ipomeanol. Toxicol. Appl. Pharmacol., 32: 147-157, 1975.
23. Boyd, M., Burka, L., Wilson, B., and Rama, B. Development of tolerance to the pulmonary toxin, 4-ipomeanol. Toxicology, 19: 85-100, 1981.
24. Rowinsky, E., Noe, D., Ettinger, D., Christian, M., Lubejko, B., Fishman, E., Sartorius, S., Boyd, M., and Donehower, R. Phase I and pharmacological study of the pulmonary cytotoxin 4-ipomeanol on a single dose schedule in lung cancer patients: hepatotoxicity is dose limiting in humans. Cancer Res., 53: 1794-1801, 1993.
25. Wittes, R. Appendix A: Grading of Toxicity. In: R. Wittes (ed.), Manual of Oncologic Therapeutics, pp. 445-448. Philadelphia: J. B. Lippincott Co., 1991.
26. Eagan, R., Fleming, T., and Schoonover, V. Evaluation of response criteria in advanced lung cancer. Cancer (Phila.), 44: 1125-1128, 1979.
27. Carney, D. N., Gazdar, A. F., Bepler, G., Guccion, J., Marangos, P., Moody, T., Zweig, M., and Minna, J. Establishment and identification of small cell lung cancer cell lines having classic and variant features. Cancer Res., 45: 2913-2923, 1985.
28. Gazdar, A., Carney, D., Nau, M., and Minna, J. Characterization of variant subclasses of cell lines derived from small cell lung cancer having distinctive biochemical, morphological, and growth properties. Cancer Res., 45: 2924-2930, 1985.
29. Stevenson, H., Gazdar, A., Phelps, R., Linnoila, I., Ihde, D., Ghosh, B., Walsh, T., Woods, E., Oie, H., O'Connor, T., Makuch, R., Kramer, B., and Mulshine, J. Tumor cell lines established in vitro: an independent prognostic factor for survival in non-small cell lung cancer. Ann. Int. Med., 113: 764-770, 1990.
30. Carmichael, J., DeGraff, W., Gazdar, A., Minna, J., and Mitchell, J. Evaluation of a tetrazolium-based semiautomated colorimetric assay: assessment of chemosensitivity testing. Cancer Res., 47: 936-942, 1987.
31. Denizot, F., and Lang, R. Modifications to the tetrazolium dye procedure giving improved sensitivity and reliability. J. Immunol. Methods, 89: 271-277, 1986.
32. Pallas, F., Murrill, E., and El-Hawari, M. Analytical Method Development and Validation of 4-Ipomeanol (NSC 349438) in Plasma. Kansas City, MO: Midwest Research Institute, 1985.
33. Yamaoka, K., Nakagawa, T., and Uno, T. Application of Akaike's information criterion in the evaluation of linear pharmacokinetic equations. J. Pharmacokinet. Biopharm., 6: 165-175, 1978.
34. Gibaldi, M., and Perrier, D. Pharmacokinetics. New York: Dekker, 1982.
35. Dutcher, J., and Boyd, M. Species and strain differences in target organ alkylation and toxicities by 4-ipomeanol: predictive value of covalent binding in studies of target organ toxicities by reactive metabolites. Biochem. Pharmacol., 28: 3367-3372, 1979.
36. Czerwinski, M., McLemore, T., Philpot, R., Nhamburo, P., Korzekwa, K., Gelboin, H., and Gonzalez, F. Metabolic activation of 4-ipomeanol by complementary DNA-expressed human cytochromes P-450: evidence for species-specific metabolism. Cancer Res., 51: 4636-4638, 1991.
37. Collins, J. M., Zaharko, D. S., Dedrick, R. L., and Chabner, B. A. Potential roles for preclinical pharmacology in Phase I clinical trials. Cancer Treat. Rep., 70: 73-80, 1986.
38. Storer, B. E. Design and analysis of Phase I clinical trials. Biometrics, 45: 925-937, 1989.
39. Goodman, S. N., Zahurak, M. L., and Piantadosi, S. Some practical improvements in the continual reassessment method for Phase I studies. Stat. Med., 14: 1149-1161, 1995.
40. Simon, R., Freidlin, B., Rubinstein, L., Arbuck, S. G., Collins, J., and Christian, M. C. Accelerated titration designs for Phase I clinical trials in oncology. J. Natl. Cancer Inst., 89: 1138-1147, 1997.