Phase II trial of a 3-hour infusion of paclitaxel in previously untreated patients with advanced non-small-cell lung cancer

Journal of Clinical Oncology

Volumn 14, Issue 1, 1996, Pages 142-148

  Millward, M J ^a   Bishop, J F ^a   Friedlander, M ^a   Levi, J A ^a   Goldstein, D ^a   Olver, I N ^a   Smith, J G ^a   Toner, G C ^a   Rischin, D ^a   Bell, D R ^a  

^a PETER MACCALLUM CANCER CENTRE   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

DEXAMETHASONE; PACLITAXEL;

ADVANCED CANCER; ALOPECIA; ARTHRALGIA; ARTICLE; BLOOD TOXICITY; CARDIOTOXICITY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DRUG TOLERABILITY; FEMALE; HEADACHE; HUMAN; HYPERSENSITIVITY REACTION; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MYALGIA; NAUSEA; NEUROPATHY; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SKIN TINGLING; STOMATITIS; VOMITING;

EID: 9044222488     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1996.14.1.142     Document Type: Article

References (35)

1. Stewart LA, Pignon JP, Parmar MKB, et al: A meta-analysis using individual patient data from randomised clinical trials (RCTS) of chemotherapy (CT) in non-small cell lung cancer (NSCLC): (3) Survival in the supportive care (SC) setting. Proc Am Soc Clin Oncol 13:337, 1994 (abstr 1118)
2. Pignon JP, Stewart LA, Souhami RL, et al: A meta-analysis using individual patient data from randomised clinical trials (RCTS) of chemotherapy (CT) in non-small cell lung cancer (NSCLC): (2) Survival in the locally advanced (LA) setting. Proc Am Soc Clin Oncol 13:334, 1994 (abstr 1109)
3. Kris M, Cohen E, Gralla R: An analysis of 134 phase II trials in non-small cell lung cancer (NSCLC). Lung Cancer 2:119, 1986 (abstr)
4. Pazdur R, Kudelka AP, Kavanagh JJ, et al: The taxoids: Paclitaxel (Taxol) and docetaxel (Taxotere). Cancer Treat Rev 19:351-386, 1993
5. Donehower RC, Rowinsky EK, Grochow LB, et al: Phase I trial of Taxol in patients with advanced cancer. Cancer Treat Rep 71:1171-1177, 1987
6. Kris MG, O'Connell JP, Gralla RJ, et al: Phase I trial of Taxol given as a 3-hour infusion every 21 days. Cancer Treat Rep 70:605-607, 1986
7. Rowinsky EK, Donehower RC: Taxol: Twenty years later, the story unfolds. J Natl Cancer Inst 83:1778-1781, 1991 (editorial)
8. Chang AY, Kim K, Glick J, et al: Phase II study of Taxol, Merbarone, and Piroxantrone in stage IV non-small-cell lung cancer: The Eastern Cooperative Oncology Group results. J Natl Cancer Inst 85:388-394, 1993
9. Murphy WK, Fossella FV, Winn RJ, et al: Phase II study of Taxol in patients with untreated advanced non-small-cell lung cancer. J Natl Cancer Inst 85:384-388, 1993
10. Eisenhauer EA, ten Bokkel Huinink WW, Swenerton KD, et al: European-Canadian randomized trial of paclitaxel in relapsed ovarian cancer: High dose versus low dose and long versus short infusion. J Clin Oncol 12:2654-2666, 1994
11. Miller AB, Hoogstraten B, Staquet M, et al: Reporting results of cancer treatment. Cancer 47:207-214, 1981
12. Dixon WJ, Brown MB, Engelman L, et al: BMDP Statistical Software Manual. Berkeley, CA, University of California, 1990
13. Schiller JH, Storer B, Tutsch K, et al: Phase I trial of 3-hour infusion of paclitaxel with or without granulocyte colony-stimulating factor in patients with advanced cancer. J Clin Oncol 12:241-248, 1994
14. Bonomi P: Brief overview of combination chemotherapy in non-small cell lung cancer. Semin Oncol 13:89-91, 1986 (suppl 3)
15. Eagan RT, Fleming TR, Schoonover V: Evaluation of response criteria in advanced lung cancer. Cancer 44:1125-1128, 1979
16. Jett JR, Su JQ, Krook JE, et al: Measurable or assessable disease in lung cancer trials: Does it matter? J Clin Oncol 12:2677-2681, 1994
17. Rowinsky EK, Donehower RC, Jones RJ, et al: Microtubule changes and cytotoxicity in leukemic cell lines treated with Taxol. Cancer Res 48:4093-4100, 1988
18. Hanauske A-R, Degen D, Hilsenbeck SG, et al: Effects of Taxotere and Taxol on in vitro colony formation of freshly explanted human tumor cells. Anticancer Drugs 3:121-124, 1992
19. Schiff PB, Fant J, Horwitz SB: Promotion of microtubule assembly in vitro by Taxol. Nature 277:665-667, 1979
20. Manfredi JJ, Parness J, Horwitz SB: Taxol binds to cellular microtubules. J Cell Biol 94:688-696, 1982
21. Arbuck SG, Canetta R, Onetto N, et al: Current dosage and schedule issues in the development of Paclitaxel (Taxol). Semin Oncol 20:31-39, 1993 (suppl 3)
22. Gelmon K, Nabholtz JM, Bontenbal M, et al: Randomized trial of two doses of paclitaxel in metastatic breast cancer after failure of standard therapy. Ann Oncol 5:198, 1994 (suppl 5, abstr 493)
23. Tamura T, Sasaki Y, Nishiwaki Y, et al: Phase I and pharmacokinetic study of paclitaxel administered by 3-hour infusion. Proc Am Soc Clin Oncol 13:132, 1994 (abstr 322)
24. Pawel J v, Wagner H, Gatzemeier U, et al: Phase II study with paclitaxel (Taxol) in advanced inoperable NSCLC. Ann Oncol 5:155, 1994 (suppl 8, abstr 779)
25. Tester W, Conn J, Desai A, Reardon D, et al: Phase II study of short infusion paclitaxel in patients with stage IV non-small cell lung cancer. Proc Am Soc Clin Oncol 14:382, 1995 (abstr 1189)
26. Gianni L, Kearns CM, Giani A, et al: Nonlinear pharmacokinetics and metabolism of paclitaxel and its pharmacokinetic/pharmacodynamic relationships in humans. J Clin Oncol 13:180-190, 1995
27. Adler LM, Herzog TJ, Williams S, et al: Analysis of exposure times and dose escalation of paclitaxel in ovarian cancer cell lines. Cancer 74:1891-1989, 1994
28. Georgiadis MS, Russell E, Johnson BE: Prolonging the exposure of human lung cancer cell lines to paclitaxel improves the cytotoxicity. Proc Am Assoc Cancer Res 35:341, 1994 (abstr 2028)
29. Greco FA, Hainsworth JD. Paclitaxel (Taxol): Phase I/II trial comparing 1-hour infusion schedules. Semin Oncol 21:3-8, 1994 (suppl 8)
30. Hainsworth JD, Thompson DS, Spigel SC, et al: Paclitaxel by 1-hour infusion in the treatment of stage IV or relapsed non-small cell lung cancer. Proc Am Soc Clin Oncol 14:364, 1995 (abstr 1116)
31. Klastersky J, Sculier JP: Paclitaxel (P) plus cisplatin (C) in non small cell lung cancer: A dose finding study. Proc Am Soc Clin Oncol 13:349, 1994 (abstr 1169)
32. Georgiadis MS, Brown JE, Schuler BS, et al: Phase I study of a four day continuous infusion of paclitaxel followed by cisplatin in patients with advanced lung cancer. Proc Am Soc Clin Oncol 14:353, 1995 (abstr 1072)
33. Rowinsky EK, Sartorious SE, Bowling MK, et al: Paclitaxel on a 3-hour schedule and carboplatin in non small cell lung cancer: Use of maximally tolerated and clinically relevant single agent doses in combination is feasible. Proc Am Soc Clin Oncol 14:354, 1995 (abstr 1075)
34. Langer CJ, Leighton J, Comis R, et al: Paclitaxel (Taxol) and carboplatin (CBDCA) in advanced non-small cell lung cancer (NSCLC): Toxicity, response and survival update. Proc Am Soc Clin Oncol 14:355, 1995 (abstr 1080)
35. Vafai D, Israel V, Zaretsky S, Natale RB: Phase I/II trial of combination carboplatin and Taxol in non small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 14:352, 1995 (abstr 1067)