Phase I trial of combined-modality therapy for localized esophageal cancer: Escalating doses of continuous-infusion paclitaxel with cisplatin and concurrent radiation therapy

Journal of Clinical Oncology

Volumn 22, Issue 1, 2004, Pages 45-52

  Brenner, Baruch ^a   Ilson, David H ^a   Minsky, Bruce D ^a   Bains, Manjit S ^a   Tong, William ^a   Gonen, Mithat ^a   Kelsen, David P ^a  

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CISPLATIN; PACLITAXEL;

ARTICLE; BLOOD SAMPLING; BONE MARROW SUPPRESSION; CANCER LOCALIZATION; CANCER RECURRENCE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG SAFETY; DRUG TOLERABILITY; ESOPHAGITIS; ESOPHAGUS CANCER; FEBRILE NEUTROPENIA; HUMAN; MAXIMUM TOLERATED DOSE; MULTIMODALITY CANCER THERAPY; NEUROPATHY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; STOMATITIS;

ADULT; AGED; ANTINEOPLASTIC AGENTS, PHYTOGENIC; CARCINOMA; COMBINED MODALITY THERAPY; DOSE-RESPONSE RELATIONSHIP, DRUG; ESOPHAGEAL NEOPLASMS; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; NEUTROPENIA; PACLITAXEL; TREATMENT OUTCOME;

EID: 4043057156     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2004.05.039     Document Type: Article

References (37)

1. Jemal AMT, Samuels A, Ghafoor A, et al: Cancer statistics, 2003. CA Cancer J Clin 53:5-26, 2003
2. Kelsen DP: Preoperative chemoradiotherapy for esophageal cancer. J Clin Oncol 19:283-285, 2001
3. Zieren HU, Muller JM, Jacobi CA, et al: Adjuvant postoperative radiation therapy after curative resection of squamous cell carcinoma of the thoracic esophagus: A prospective randomized trial. World J Surg 19:444-449, 1995
4. Ando N, Iizuka T, Kakegawa T, et al: A randomized trial of surgery with and without chemotherapy for localized squamous carcinoma of the thoracic esophagus: The Japan Clinical Oncology Group study. J Thorac Cardiovasc Surg 114:205-209, 1997
5. Kelsen DP, Ginsberg R, Pajak TF, et al: Chemotherapy followed by surgery compared with surgery alone for localized esophageal cancer. N Engl J Med 339:1979-1984, 1998
6. Herskovic A MK, Martz K, Al-Sarraf M, et al: Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med: 1593-1598, 1992
7. Al-Sarraf M, Martz K, Herskovic A, et al: Progress report of combined chemoradiotherapy versus radiotherapy alone in patients with esophageal cancer: An intergroup study. J Clin Oncol: 277-284, 1997
8. Walsh T, Noonan N, Hollywood D, et al: A comparison of multimodal therapy and surgery for esophageal adenocarcinoma. N Engl J Med: 462-467, 1996
9. Burmeister BH, Smithers BM, Fitzgerald F, et al: A randomized phase III trial of preoperative chemoradiation followed by surgery (CR-S) versus surgery alone (S) in localized resectable cancer of the esophagus. Proc Am Soc Clin Oncol 21:130A, 2002 (abstr 518)
10. Milas LHN. Mason KA, Kurdoglu B, et al: Enhancement of tumor radio-response of a murine mammary carcinoma by paclitaxel. Cancer Res 54:3506-3510, 1994
11. Liebmann JCJ, Fisher J, Teague D, et al: In vitro studies of Taxol as a radiation sensitizer in human tumor cells. J Natl Cancer Inst 86:441-446, 1994
12. Seidman AD, Hochhauser D, Gollub M, et al: Ninety-six-hour paclitaxel infusion after progression during short taxane exposure: A phase II pharmacokinetic and pharmacodynamic study in metastatic breast cancer. J Clin Oncol 14:1877-1884, 1996
13. Smith RE, Brown AM, Mamounas EP, et al: Randomized trial of 3-hour versus 24-hour infusion of high-dose paclitaxel in patients with metastatic or locally advanced breast cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-26. J Clin Oncol 17:3403-3411, 1999
14. Georgiadis MS, Schuler BS, Brown JE, et al: Paclitaxel by 96-hour continuous infusion in combination with cisplatin: A phase I trial in patients with advanced lung cancer. J Clin Oncol 15:735-743, 1997
15. Fleming I, Cooper J, Henson D, et al: American Joint Committee on Cancer Staging Manual. Philadelphia, PA, Lippincott-Raven, 1997
16. Choy H, Akerley W, Safran H, et al: Phase I trial of outpatient weekly paclitaxel and concurrent radiation therapy for advanced non-small cell lung cancer. J Clin Oncol 12:2682-2686, 1994
17. Longnecker SM, Donehower RC, Cates AE, et al: High-performance liquid chromatographic assay for Taxol in human plasma and urine and pharmacokinetics in a phase I trial. Cancer Treat Rep 71:53-59, 1987
18. Kaplan EL, Meier P: Non-parametric estimation from incomplete observation. J Am Stat Assoc 53:457-481, 1958
19. Urba SG, Orringer MB, Turrisi A, et al: Randomized trial of preoperative chemoradiation versus surgery alone in patients with locoregional esophageal carcinoma. J Clin Oncol 19:305-313, 2001
20. Bosset JF, Gignoux M, Triboulet JP, et al: Chemoradiotherapy followed by surgery compared with surgery alone in squamous-cell cancer of the esophagus. N Engl J Med 337:161-167, 1997
21. Ilson D, Arquette M, Costa F, et al: Preoperative paclitaxel and cisplatin in esophageal cancer: A phase II multicenter trial. Proc Am Soc Clin Oncol 16:926A, 1997 (abstr)
22. Ilson DH, Forastiere A, Arquette M, et al: A phase II trial of paclitaxel and cisplatin in patients with advanced carcinoma of the esophagus. Cancer J 6:316-323, 2000
23. Polee MB, Eskens FA, van der Burg ME, et al: Phase II study of bi-weekly administration of paclitaxel and cisplatin in patients with advanced oesophageal cancer. Br J Cancer 86:669-673, 2002
24. Cooper JS GM, Herskovic A, Macdonald JS, et al: Chemoradiotherapy of locally advanced esophageal cancer: Long-term follow-up of a prospective randomized trial (RTOG 85-01)-Radiation Therapy Oncology Group. JAMA 281:1623-1627, 1999
25. Heath EI, Burtness BA, Heitmiller RF, et al: Phase II evaluation of preoperative chemoradiation and postoperative adjuvant chemotherapy for squamous cell and adenocarcinoma of the esophagus. J Clin Oncol 18:868-876, 2000
26. Safran HGH, Akerman P, Hesketh PJ, et al: Paclitaxel, cisplatin, and concurrent radiation for esophageal cancer. Cancer Invest 19:1-7, 2001
27. Cornelia G, Frasci G, Scoppa G, et al: Weekly paclitaxel/cisplatin with concurrent radiotherapy in patients with locally advanced non-small cell lung cancer: A phase I study. Semin Oncol 24:S12-S116, 1997 (suppl 4)
28. Isokangas OP, Joensuu H, Halme M, et al: Paclitaxel (Taxol) and carboplatin followed by concomitant paclitaxel. cisplatin and radiotherapy for inoperable stage III NSCLC. Lung Cancer 20:127-133, 1998
29. Adelstein DJ, Rice TW, Rybicki LA, et al: Does paclitaxel improve the chemoradiotherapy of locoregionally advanced esophageal cancer? A nonrandomized comparison with fluorouracil-based therapy. J Clin Oncol 18:2032-2039, 2000
30. Breathnach OS, Georgiadis MS, Schuler BS, et al: Phase II trial of paclitaxel by 96-hour continuous infusion in combination with cisplatin for patients with advanced non-small cell lung cancer. Clin Cancer Res 6:2670-2676, 2000
31. Breathnach OS, Kasturi V, Kaye F, et al: Phase II neoadjuvant trial of paclitaxel by 96-hour continuous infusion (CIVI) in combination with cisplatin followed by chest radiotherapy for patients with stage III non-small-cell lung cancer. Am J Clin Oncol 25;269-273, 2002
32. O'Connell MJ, Martenson JA, Wieand HS, et al: Improving adjuvant therapy for rectal cancer by combining protracted-infusion fluorouracil with radiation therapy after curative surgery. N Engl J Med 331:502-507, 1994
33. Lopes NM, Adams EG, Pitts TW, et al: Cell kill kinetics and cell cycle effects of Taxol on human and hamster ovarian cell lines. Cancer Chemother Pharmacol 32:235-242, 1993
34. Zanelli GD, Quaia M, Robieux I, et al: Paclitaxel as a radiosensitiser: A proposed schedule of administration based on in vitro data and pharmacokinetic calculations. Eur J Cancer 1997 33:486-492, 1997
35. Liebmann JE, Cook JA, Lipschultz C, et al: Cytotoxic studies of paclitaxel (Taxol) in human tumour cell lines. Br J Cancer 68:1104-1109, 1993
36. Gianni LKC, Giani A, Capri G, et al: Nonlinear pharmacokinetics and metabolism of paclitaxel and its pharmacokinetic/pharmacodynamic relationships in humans. J Clin Oncol 13:180-190, 1995
37. Ohtsu T, Sasaki Y, Tamura T, et al: Clinical pharmacokinetics and pharmacodynamics of paclitaxel: A 3-hour infusion versus a 24-hour infusion. Clin Cancer Res 1:599-606, 1995