A phase I study of radiation therapy and twice-weekly gemcitabine and cisplatin in patients with locally advanced pancreatic cancer

International Journal of Radiation Oncology Biology Physics

Volumn 55, Issue 5, 2003, Pages 1305-1310

  Martenson Jr , James A ^a   Vigliotti, Antonio P G ^b   Pitot, Henry C ^a   Geeraerts, Louis H ^c   Sargent, Daniel J ^a   Haddock, Michael G ^a   Ghosh, Chirantan ^b   Keppen, Michael D ^d   Fitch, Tom R ^e   Goldberg, Richard M ^a   Schwartz, Roberta ^a  

^a MAYO CLINIC   (United States)

^b Cedar Rapids Oncology Project CCOP   (United States)

^c MeritCare Hospital   (United States)

^d Sioux Community Cancer Consortium   (United States)

^e Scottsdale CCOP   (United States)

Author keywords

Cisplatin; Gemcitabine; Pancreatic cancer; Radiation therapy

Indexed keywords

CHEMOTHERAPY; ONCOLOGY; TOXICITY; TUMORS;

DRUG EXPOSURE;

RADIOTHERAPY;

CISPLATIN; GEMCITABINE;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; AGED; ANOREXIA; ARTICLE; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CANCER RADIOTHERAPY; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEHYDRATION; DYSPHAGIA; ENTERITIS; FEMALE; HUMAN; HYPERGLYCEMIA; INFECTION; LETHARGY; LYMPHOCYTOPENIA; MALE; MULTIMODALITY CANCER THERAPY; NAUSEA AND VOMITING; NEUTROPENIA; PANCREAS ADENOCARCINOMA; PANCREAS CANCER; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RADIATION DOSE FRACTIONATION; RADIATION INDUCED EMESIS; SAFETY; THROMBOCYTOPENIA; TOXICITY; VOMITING;

EID: 0345269071     PISSN: 03603016     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0360-3016(02)04399-7     Document Type: Article

References (31)

1. Cullinan S., Moertel C.G., Wieand H.S., et al. A phase III trial on the therapy of advanced pancreatic carcinoma. Evaluations of the Mallinson regimen and combined 5-fluorouracil, doxorubicin, and cisplatin. Cancer. 65:1990;2207-2212.
2. Moertel C.G., Childs D.S. Jr, Reitemeier R.J., et al. Combined 5-fluorouracil and supervoltage radiation therapy of locally unresectable gastrointestinal cancer. Lancet. 2:1969;865-867.
3. Moertel C.G., Frytak S., Hahn R.G., et al. Therapy of locally unresectable pancreatic carcinoma A randomized comparison of high dose (6000 rads) radiation alone, moderate dose radiation (4000 rads + 5-fluorouracil), and high dose radiation + 5-fluorouracil: The Gastrointestinal Tumor Study Group. Cancer. 48:1981;1705-1710.
4. Treatment of locally unresectable carcinoma of the pancreas: Comparison of combined-modality therapy (chemotherapy plus radiotherapy) to chemotherapy alone. J Natl Cancer Inst. 80:1988;751-755.
5. Nitecki S.S., Sarr M.G., Colby T.V., et al. Long-term survival after resection for ductal adenocarcinoma of the pancreas. Is it really improving? Ann Surg. 221:1995;59-66.
6. Kalser M.H., Ellenberg S.S. Pancreatic cancer Adjuvant combined radiation and chemotherapy following curative resection. Arch Surg. 120:1985;899-903.
7. Klinkenbijl J.H., Jeekel J., Sahmoud T., et al. Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas and periampullary region Phase III trial of the EORTC Gastrointestinal Tract Cancer Cooperative Group. Ann Surg. 230:1999;776-782.
8. Burris H.A. III, Moore M.J., Andersen J., et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer A randomized trial. J Clin Oncol. 15:1997;2403-2413.
9. Plunkett W., Huang P., Xu Y.Z., et al. Gemcitabine Metabolism, mechanisms of action, and self-potentiation. Semin Oncol. 22:(Suppl. 11):1995;3-10.
10. Grunewald R., Abbruzzese J.L., Tarassoff P., et al. Saturation of 2′,2′-difluorodeoxycytidine 5′-triphosphate accumulation by mononuclear cells during a phase I trial of gemcitabine. Cancer Chemother Pharmacol. 27:1991;258-262.
11. Lawrence T.S., Chang E.Y., Hahn T.M., et al. Delayed radiosensitization of human colon carcinoma cells after a brief exposure to 2′,2′-difluoro-2′deoxycytidine (gemcitabine). Clin Cancer Res. 3:1997;777-782.
12. Fichtinger-Schepman A.M., van der Veer J.L., den Hartog J.H., et al. Adducts of the antitumor drug cis-diamminedichloroplatinum (II) with DNA Formation, identification, and quantitition. Biochemistry. 24:1985;707-713.
13. Peters G.J., Bergman A.M., Ruiz van Haperen V.W., et al. Interaction between cisplatin and gemcitabine in vitro and in vivo. Semin Oncol. 22:(Suppl. 11):1995;72-79.
14. Symon Z., Davis M., McGinn C.J., et al. Concurrent chemoradiotherapy with gemcitabine and cisplatin for pancreatic cancer From the laboratory to the clinic. Int J Radiat Oncol Biol Phys. 53:2002;140-145.
15. Burke MB, Wilkes GM, Berg D, et al. Cancer chemotherapy: A nursing process approach. Boston, MA: Jones and Bartlett Publishers; 1991. p. 438-441.
16. Kaplan E.L., Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 53:1958;457-481.
17. Boven E., Schipper H., Erkelens C.A., et al. The influence of the schedule and the dose of gemcitabine on the anti-tumour efficacy in experimental human cancer. Br J Cancer. 68:1993;52-56.
18. Shewach D.S., Hahn T.M., Chang E., et al. Metabolism of 2′,2′-difluoro-2′-deoxycytidine and radiation sensitization of human colon carcinoma cells. Cancer Res. 54:1994;3218-3223.
19. Grunewald R., Kantarjian H., Keating M.J., et al. Pharmacologically directed design of the dose rate and schedule of 2′,2′-difluorodeoxycytidine (gemcitabine) administration in leukemia. Cancer Res. 50:1990;6823-6826.
20. Abbruzzese J.L., Grunewald R., Weeks E.A., et al. A phase I clinical, plasma, and cellular pharmacology study of gemcitabine. J Clin Oncol. 9:1991;491-498.
21. Grunewald R., Kantarjian H., Du M., et al. Gemcitabine in leukemia A phase I clinical, plasma, and cellular pharmacology study. J Clin Oncol. 10:1992;406-413.
22. Blackstock A.W., Bernard S.A., Richards F., et al. Phase I trial of twice-weekly gemcitabine and concurrent radiation in patients with advanced pancreatic cancer. J Clin Oncol. 17:1999;2208-2212.
23. O'Rourke T.J., Brown T.D., Havlin K., et al. Phase I clinical trial of gemcitabine given as an intravenous bolus on 5 consecutive days. Eur J Cancer. 3:1994;417-418.
24. Pipas J.M., Mitchell S.E., Barth R.J. Jr, et al. Phase I study of twice-weekly gemcitabine and concomitant external-beam radiotherapy in patients with adenocarcinoma of the pancreas. Int J Radiat Oncol Biol Phys. 50:2001;1317-1322.
25. Poplin E.A., Corbett T., Flaherty L., et al. Difluorodeoxycytidine (dFdC) - gemcitabine A phase I study. Invest New Drugs. 10:1992;165-170.
26. Fields M.T., Eisbruch A., Normolle D., et al. Radiosensitization produced in vivo by once- vs twice-weekly 2′2′-difluoro-2′-deoxycytidine (gemcitabine). Int J Radiat Oncol Biol Phys. 47:2000;785-791.
27. Eisbruch A., Shewach D.S., Bradford C.R., et al. Radiation concurrent with gemcitabine for locally advanced head and neck cancer A phase I trial and intracellular drug incorporation study. J Clin Oncol. 19:2001;792-799.
28. Hidalgo M., Castellano D., Paz-Ares L., et al. Phase I-II study of gemcitabine and fluorouracil as a continuous infusion in patients with pancreatic cancer. J Clin Oncol. 17:1999;585-592.
29. Crane C.H., Wolff R.A., Abbruzzese J.L., et al. Combining gemcitabine with radiation in pancreatic cancer Understanding important variables influencing the therapeutic index. Semin Oncol. 28:(Suppl. 10):2001;25-33.
30. McGinn C.J., Zalupski M.M., Shureiqi I., et al. Phase I trial of radiation dose escalation with concurrent weekly full-dose gemcitabine in patients with advanced pancreatic cancer. J Clin Oncol. 19:2001;4202-4208.
31. Yavuz A.A., Aydin F., Yavuz M.N., et al. Radiation therapy and concurrent fixed dose amifostine with escalating doses of twice-weekly gemcitabine in advanced pancreatic cancer. Int J Radiat Oncol Biol Phys. 51:2001;974-981.