Phase I dose escalation trial of weekly docetaxel plus irinotecan in patients with advanced cancer

Cancer Biology and Therapy

Volumn 1, Issue 6, 2002, Pages 646-651

  Bleickardt, Eric ^a   Argiris, Athanassios ^b   Rich, Randy ^a   Blum, Kathi ^a   McKeon, Anne ^a   Tara, Harold ^a   Zelterman, Daniel ^a   Burtness, Barbara ^a   Davies, Marianne J ^a   Murren, John R ^a  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b NORTHWESTERN UNIVERSITY   (United States)

Author keywords

CPT 11; Docetaxel; Irinotecan; Lung cancer; Pancreatic cancer; Phase I

Indexed keywords

ANTINEOPLASTIC AGENT; CAMPTOTHECIN; DOCETAXEL; DRUG DERIVATIVE; IRINOTECAN; PACLITAXEL; TAXOID;

ADULT; AGED; CLINICAL TRIAL; COMPARATIVE STUDY; DOSE RESPONSE; DRUG ADMINISTRATION; FEMALE; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM; PATHOLOGY; PHASE 1 CLINICAL TRIAL; REVIEW; SALVAGE THERAPY; TREATMENT OUTCOME;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS; PACLITAXEL; SALVAGE THERAPY; TAXOIDS; TREATMENT OUTCOME;

EID: 0038650953     PISSN: 15384047     EISSN: 15558576     Source Type: Journal    
DOI: 10.4161/cbt.314     Document Type: Article

References (33)

1. Hsiang, YH, Hertzberg R, Hecht S, Liu L. Camptothecin induces protein-linked DNA breaks via mammalian DNA topoisomerase I. J Biol Chem 1985; 260:14873-8. (Pubitemid 16211028)
2. Horowitz SB, Horowitz M. Effects of camptothecin on the breakage and repair of DNA during the cell cycle. Cancer Res 1973; 33:2834-6.
3. Li L, Fraser T, Olin E, Bhuyan B. Action of camptothecin on mammalian cells in culture. Cancer Res 1972; 32:2643-50.
4. Rothenberg ML, Burris HA, Eckardt JR, Rinaldi DA, Weiss GR, Smith S, et al. Phase I/II study of topotecan + cisplatin in patients with non-small cell lung cancer (NSCLC) (Meeting abstract). Proc Annu Meet Am Soc Clin Oncol 1993.
5. Rothenberg ML, Eckardt JR, Kuhn JG, Burris HA, Nelson J, Hilsenbeck SG, et al. Phase II trial of irinotecan in patients with progressive or rapidly recurrent colorectal cancer. J Clin Oncol 1996; 14:1128-35. (Pubitemid 26105519)
6. Abigerges D, Chabot GG, Armand J, Herait P, Gouyette A, Gandia D. Phase I and pharmacologic studies of the camptothecin analog irinotecan administered every 3 weeks in cancer patients. J Clin Oncol 1995; 13:210-21.
7. Taguchi T. Clinical studies of CPT-11 in Japan. Gan To Kaguko Ryoho 1992;22 (suppl 3):277-83.
8. Wagener DJ, Verdonk HE, Dirix LY, Catimel G, Siegenthaler P, Buitenhuis M, et al. Phase II trial of CPT-11 in patients with advanced pancreatic cancer, an EORTC early clinical trials group study. Ann Oncol 1995; 6:129-32.
9. Fulton B, Spencer CM. Docetaxel. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic efficacy in the management of metastatic breast cancer. Drugs 1996; 51:1075-92.
10. Riou JF, Naudin A, Lavelle F. Effects of Taxotere on murine and human tumor cell lines. Biochem Biophys Res Commun 1992; 187:164-70.
11. Vogel M, Hilsenbeck SG, Depenbrock H, Danhauser-Riedl S, Block T, Nekarda H, et al. Preclinical activity of taxotere (RP 56976, NSC 628503) against freshly explanted clonogenic human tumour cells: comparison with taxol and conventional antineoplastic agents. Eur J Cancer 1993; 14:2009-14. (Pubitemid 23324363)
12. Rougier P, Adenis A, Ducreux M, de Forni M, Bonneterre J, Dembak M, et al. A phase II study: docetaxel as first-line chemotherapy for advanced pancreatic adenocarcinoma. Eur J Cancer 2000; 36:1016-25. (Pubitemid 30316427)
13. Lin YC, Chang HK, Wang CH, Chen JS, Liaw CC. Single-agent docetaxel in metastatic breast cancer patients pre-treated with anthracyclines and paclitaxel: partial cross-resistance between paclitaxel and docetaxel. Anticancer Drugs 2000; 11:617-21.
14. Bissery MC, Vrignaud P, Lavelle F. In vivo evaluation of the docetaxel-irinotecan combination. Proc Amer Assoc Cancer Res 1996; 37:378 (abstr 2578).
15. Kano Y, Akutsu M, Tsunoda S, Mori K, Suzuki K, Adachi KI. In vitro schedule-dependent interaction between paclitaxel and SN-38 (the active metabolite of irinotecan) in human carcinoma cell lines. Cancer Chemother Pharmacol 1998; 42:91-8.
16. Pei XH, Nakanishi Y, Takayama K, Bai F, Kawasaki M, Tsuruta N, et al. Effect of CPT-11 in combination with other anticancer agents in lung cancer cells. Anti-Cancer Drugs 1997; 8:231-7. (Pubitemid 27157932)
17. Adjei AA, Klein CE, Kastrissios H, Goldberg RM, Alberts SR, Pitot HC, et al. Phase I and pharmacokinetic study of irinotecan and docetaxel in patients with advanced solid tumors: preliminary evidence of clinical activity. J Clin Oncol 2000; 18:1116-23. (Pubitemid 30123791)
18. Couteau C, Risse ML, Ducreux M, Lefresne-Soulas F, Riva A, Lebecq A, et al. Phase I and pharmacokinetic study of docetaxel and irinotecan in patients with advanced solid tumors. J Clin Oncol 2000; 18:3545-52.
19. Masuda N, Negoro S, Kudoh S, Sugiura T, Nakagawa K, Saka H, et al. Phase I and pharmacologic study of docetaxel and irinotecan in advanced non-small-cell lung cancer. J Clin Oncol 2000; 18:2996-3003. (Pubitemid 30644124)
20. Font A, Sanchez JM, Rosell R, Taron M, Martinez E, Guillot M, et al. Phase I study of weekly CPT-11 (irinotecan)/docetaxel in patients with advanced solid tumors. Lung Cancer 2002; 37:213-8. (Pubitemid 34831812)
21. Seneviratne L, Garcia A, Rogers M, Jeffers S, Bernal G, Angeles A, et al. Phase I clinical and pharmacokinetic (PK) trial of docetaxel (D) and irinotecan (I) administered on a weekly schedule. Proc Am Soc Clin Oncol 2000; 19:225a.
22. Satouchi M, Takada Y, Takeda K, Yamamoto N, Negoro S, Nakagawa K, et al. Randomized phase II study of docetaxel (DOC) plus cisplatin (CDDP) versus DOC plus irinotecan in advanced non-small cell lung cancer (NSCLC); a west Japan thoracic oncology group (WJTOG) study. Proc Am Soc Clin Oncol 2001; 20:329a.
23. Maenpaa J, Kaar K, Kivinen S, Pohto M, Jekunen A. Docetaxel and CPT-11 for recurrent ovarian cancer-a phase II study. Proc Am Soc Clin Oncol 1999; 18:363a.
24. Knuuttila A, Ollikainen T, Halme M, Mali P, Kivisaari L, Linnainmaa K, et al. Docetaxel and irinotecan (CPT-11) in the treatment of malignant pleural mesothelioma - a feasibility study. Anticancer Drugs 2000; 11:257-61. (Pubitemid 30416954)
25. Enrech S, Belon J, Mendez M. A phase II study of docetaxel in combination with irinotecan (CPT-11) in locally advanced or metastatic gastric cancer. GOTI study group. Proc Am Soc Clin Oncol 2001; 20:144b.
26. Kurtz J, Husseini F, Negrier S, Limacher J, Wagner J, Borel C, et al. Docetaxel (DOC) and irinotecan (IRI) combination chemotherapy in advanced pancreatic cancer (APC). A phase II study. Proc Am Soc Clin Oncol 2001; 20:141b.
27. Abigerges D, Armand JP, Chabot GG, Da Costa L, Fadel E, Cote C, et al. Irinotecan (CPT-11) high-dose escalation using intensive high-dose loperamide to control diarrhea. J Natl Cancer Inst 1994; 86:446-9. (Pubitemid 24081877)
28. Fossella FV, DeVore R, Kerr RN, Crawford J, Natale RR, Dunphy F, et al. Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. The TAX 320 Non-Small Cell Lung Cancer Study Group. J Clin Oncol 2000; 18:2354-62. (Pubitemid 30415821)
29. Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, O'Rourke M, et al. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 2000; 18:2095-103. (Pubitemid 30324363)
30. Burstein HJ, Manola J, Younger J, Parker LM, Bunnell CA, Scheib R, et al. Docetaxel administered on a weekly basis for metastatic breast cancer. J Clin Oncol 2000;18(6):1212-9. (Pubitemid 30159838)
31. Loeffler T, Freund W, Droge C, Hausamen T. Activity of weekly Taxtotere (txt) in patients with metastatic breast cancer. Proc Am Soc Clin Oncol 1998; 17:113a.
32. Socinski M, Unger K, Peterman H, Gillenwater H, Schell M, Bakri K. Second-line (SL) weekly paclitaxel (P) in patients (pts) with advanced non-small cell lung cancer (NSCLC) failing first-line (FL) carboplatin/paclitaxel (C/P). Lung Cancer 2000; 29 (suppl 1):S6-S7.
33. Alvarez A, Mickiewicz E, Brosio C, Giglio R, Cinat G, Rodger J, et al. Reinduction of response with weekly Taxol (T) in advanced breast cancer (ABC). Proc Am Soc Clin Oncol 1999; 18:165a.