Phase I trial of taxol given as a 3-hour infusion every 21 days

M. G. Kris, J. P. O'Connell, Richard J. Gralla, M. S. Wertheim, R. M. Parente, P. B. Schiff, C. W. Young

Research output: Contribution to journalArticle

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Abstract

Taxol is a unique plant product that promotes in vitro assembly of microtubules. In a phase I trial, adults with advanced solid tumors were given taxol (formulated with cremophor EL and dehydrated alcohol) as a 3-hour iv infusion every 21 days. The total dose administered ranged from 15 to 230 mg/m2 in nine escalation steps. Leukopenia, thrombocytopenia, nausea and vomiting, alopecia, stomatitis, transient rashes, increases in serum triglyceride levels, and hypersensitivity reactions were observed. Hypersensitivity reactions characterized by acute dyspnea, generalized erythema, and hypotension immediately following the initiation of the taxol infusion occurred in three of five patients receiving ≥190 mg/m2 (18% of patients overall). No antitumor activity was observed. Hypersensitivity reactions constituted a treatment-limiting toxicity for this preparation of taxol given on this schedule over the dosage range examined. With the severity and unpredictability of the hypersensitivity reactions, further usage of taxol is not indicated with this drug formulation on this administration schedule. Further studies are warranted to uncover ways to permit the safe administration of taxol.

Original languageEnglish (US)
Pages (from-to)605-607
Number of pages3
JournalCancer Treatment Reports
Volume70
Issue number5
StatePublished - 1986
Externally publishedYes

Fingerprint

Paclitaxel
Hypersensitivity
Appointments and Schedules
Drug Compounding
Stomatitis
Alopecia
Leukopenia
Erythema
Exanthema
Microtubules
Thrombocytopenia
Dyspnea
Hypotension
Nausea
Vomiting
Triglycerides
Alcohols
Serum
Neoplasms

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Kris, M. G., O'Connell, J. P., Gralla, R. J., Wertheim, M. S., Parente, R. M., Schiff, P. B., & Young, C. W. (1986). Phase I trial of taxol given as a 3-hour infusion every 21 days. Cancer Treatment Reports, 70(5), 605-607.

Phase I trial of taxol given as a 3-hour infusion every 21 days. / Kris, M. G.; O'Connell, J. P.; Gralla, Richard J.; Wertheim, M. S.; Parente, R. M.; Schiff, P. B.; Young, C. W.

In: Cancer Treatment Reports, Vol. 70, No. 5, 1986, p. 605-607.

Research output: Contribution to journalArticle

Kris, MG, O'Connell, JP, Gralla, RJ, Wertheim, MS, Parente, RM, Schiff, PB & Young, CW 1986, 'Phase I trial of taxol given as a 3-hour infusion every 21 days', Cancer Treatment Reports, vol. 70, no. 5, pp. 605-607.
Kris MG, O'Connell JP, Gralla RJ, Wertheim MS, Parente RM, Schiff PB et al. Phase I trial of taxol given as a 3-hour infusion every 21 days. Cancer Treatment Reports. 1986;70(5):605-607.
Kris, M. G. ; O'Connell, J. P. ; Gralla, Richard J. ; Wertheim, M. S. ; Parente, R. M. ; Schiff, P. B. ; Young, C. W. / Phase I trial of taxol given as a 3-hour infusion every 21 days. In: Cancer Treatment Reports. 1986 ; Vol. 70, No. 5. pp. 605-607.
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