Phase II evaluation of 96-hour paclitaxel infusion in advanced (recurrent or metastatic) squamous cell carcinoma of the head and neck (E3395): A trial of the Eastern Cooperative Oncology Group

Cancer Investigation

Volumn 22, Issue 6, 2004, Pages 823-831

  Langer, Corey J ^a   Li, Yi ^b   Jennings, Timothy ^c   DeConti, Ronald C ^d   Nair, Suresh ^e   Cohen, Roger B ^a   Forastiere, Arlene A ^f  

^a FOX CHASE CANCER CENTER   (United States)

^b DANA FARBER CANCER INSTITUTE   (United States)

^c ALBANY MEDICAL COLLEGE   (United States)

^d H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^e GEISINGER MEDICAL CENTER   (United States)

^f JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

96 Hr paclitaxel; Metastatic squamous cell carcinoma of head and neck (SCCHN); Relapsed SCCHN; SCCHN

Indexed keywords

ANTIHISTAMINIC AGENT; CIMETIDINE; DEXAMETHASONE; DIPHENHYDRAMINE; HEPARIN; PACLITAXEL;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ARTHRALGIA; ARTICLE; CANCER ADJUVANT THERAPY; CANCER RECURRENCE; CANCER SURVIVAL; CARDIOTOXICITY; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; CONTINUOUS INFUSION; DEHYDRATION; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG EXPOSURE; DRUG FATALITY; DRUG HYPERSENSITIVITY; DRUG INFUSION; DRUG RESPONSE; EDEMA; ESOPHAGITIS; EVALUATION; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; GRANULOCYTOPENIA; HEAD AND NECK CANCER; HUMAN; HYPOPHARYNX CANCER; INFECTION; LARYNX CANCER; LEUKOPENIA; LIVER TOXICITY; LUNG TOXICITY; MAJOR CLINICAL STUDY; MALE; METABOLIC DISORDER; METASTASIS; MOTONEURON; MOUTH CANCER; NASOPHARYNX CANCER; OROPHARYNX CANCER; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; SIDE EFFECT; SKIN TOXICITY; SQUAMOUS CELL CARCINOMA; STOMATITIS; SURVIVAL RATE; SURVIVAL TIME; SWEATING; THROMBOCYTOPENIA; TIME SERIES ANALYSIS; UROGENITAL TRACT DISEASE; VOMITING; WEIGHT GAIN; WEIGHT REDUCTION;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS, PHYTOGENIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, SQUAMOUS CELL; COHORT STUDIES; FEMALE; HEAD AND NECK NEOPLASMS; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; PACLITAXEL; SURVIVAL RATE;

EID: 10844282026     PISSN: 07357907     EISSN: None     Source Type: Journal    
DOI: 10.1081/CNV-200039628     Document Type: Article

References (27)

1. Moring, C.C.; Squires, T.S.; Tony, T. Cancer statistics. CA Cancer J. Clin. 1992, 42, 19-38.
2. Mitchell, E.P.; Rodriguez, C.V. Head and neck, lung, gastrointestinal and pediatric cancers. Cancer Bull. 1988, 40, 86.
3. Pfister, D.G.; Strong, E.; Harrison, L.; et al. Larynx preservation with combined chemotherapy and radiation therapy in advanced but resectable head and neck cancer. J. Clin. Oncol. 1991, 9, 850-859.
4. The Department of Veterans Affairs Laryngeal Cancer Study Group. Induction chemotherapy plus radiation compared with surgery plus radiation in patients with advanced laryngeal cancer. N. Engl. J. Med. 1991, 324, 1685-1690.
5. Adjuvant chemotherapy for advanced head and neck squamous carcinoma. Final report of the head and neck contracts program. Cancer 1987, 60, 301-311.
6. Ervin, T.J.; Clark, J.R.; Weichselbaum, R.R.; et al. An analysis of induction and adjuvant chemotherapy in the multidisciplinary treatment of squamous-cell carcinoma of the head and neck. J. Clin. Oncol. 1987, 5, 10-20.
7. Million, R.R.; Cassisi, N.J.; Clark, J.R. Cancer of the head and neck. In Cancer: Principles and Practice of Oncology; DeVita, V.T., Hellman, S., Rosenberg, S.A., Eds.; Lippincott: Philadelphia, PA, 1989; 488-590.
8. Glick, J.H.; Taylor, S.G. Integration of chemotherapy into a combined modality treatment plan for head and neck cancer: a review. Int. J. Radiat. Oncol. Biol. Phys. 1981, 7, 229-242.
9. Al-Sarraf, M. Head and neck cancer: chemotherapy concepts. Semin. Oncol. 1988, 15, 70-85.
10. Urba, S.G.; Forastiere, A.A. Systemic therapy of head and neck cancer: most effective agents, areas of promise. Oncology 1989, 3, 79-98.
11. Kies, M.S.; Levitan, N.; Hong, K.W. Chemotherapy of head and neck cancer. Otolaryngol. Clin. North Am. 1995, 18, 533-541.
12. Recondo, G.; Armand, J.P.; Tellez-Bernal, E.; et al. Recurrent and/or metastatic head and neck squamous cell carcinoma: a clinical, univariate and multivariate analysis of response and survival with cisplatin-based chemotherapy. Laryngoscope 1991, 101, 494-501.
13. Forastiere, A.A.; Metch, B.; Schuller, D.E.; et al. Randomized comparison of cisplatin plus fluorouracil and carboplatin plus fluorouracil versus methotrexate in advanced squamous cell carcinoma of the head and neck. A Southwest Oncology Group Study. J. Clin. Oncol. 1991, 12, 1245-1251.
14. Jacobs, C.; Lyman, G.; Valez-Garcia, E.; et al. A Phase III randomized study comparing cisplatin and fluorouracil as single agents and in combination for advanced squamous cell carcinoma of the head and neck. J. Clin. Oncol. 1992, 10, 257-263.
15. Forastiere, A.A.; Urba, S.G. Single-agent paclitaxel and paclitaxel plus ifosfamide in the treatment of head and neck cancer. Semin. Oncol. 1995, 22 (3 Suppl. 6), 24-27.
16. Liebman, J.E.; Cook, J.A.; Lipschultz, C.; et al. Cytotoxic studies of paclitaxel in human tumor cell lines. Br. J. Cancer 1993, 63, 1104-1109.
17. Chang, A.; Boros, L.; Garrow, G.; Asbury, R. Paclitaxel by 3-hour infusion followed by 96-hour infusion on failure in patients with refractory malignant disease. Semin. Oncol. 1995, 22 (3 Suppl. 6), 124-127.
18. Wilson, W.H.; Berg, S.L.; Bryant, G.; et al. Paclitaxel in doxorubicin or mitoxantrone-refractory breast cancer: a phase I/II trial of 96-hour infusion. J. Clin. Oncol. 1994, 12, 1621-1625.
19. Seidman, A.D.; Hochhouser, 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. 1994, 14, 1877-1884.
20. Hudes, G.; Nathan, F.E.; Khater, C.; et al. Paclitaxil plus estramustine in metastatic hormone-refractory prostate cancer. Semin. Oncol. 1995, 22 (suppl. 12), 41-45.
21. Georgiadis, M.S.; Schuller, B.S.; Brown, J.E.; et al. Paclitaxil by 96-hour continuous infusion in combination with cisplatin: a phase I trial in patients with advanced lung cancer. J. Clin. Oncol. 1997, 15, 735-743.
22. Oken, M.M.; Creech, R.H.; Tormey, D.C.; et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982, 5, 649-655.
23. Agresti, A. Categorical Data Analysis; Wiley: New York, 1990.
24. Bahadur, RR. Stochastic comparison of tests. Ann. Math. Stat. 1960, 31, 276-295.
25. Cox, DR. Regression models and life tables. J.R. Stat. Soc. 1972, 34, 187-202.
26. Kaplan, E.L.; Meier, P. Nonparametric estimation of incomplete observations. J. Am. Stat. Assoc. 1958, 53, 457-481.
27. Murphy, B.; Li, Y.; Cella, D.; et al. Phase III study comparing cisplatin (C) and 5-Flurouracil (F) vs. cisplatin and paclitaxel (T) in metastatic/recurrent head and neck cancer (MHNC). Proc. Am. Soc. Clin. Oncol. 2001, 20, A-894 (abstract).