Phase I studies of continuous-infusion paclitaxel given with standard aggressive radiation therapy for locally advanced solid tumors

D. I. Rosenthal, L. G. Close, J. A. Lucci, S. C. Schold, J. Truelson, H. Fathallah-Skaykh, B. Kamen, F. M. Vultch, A. F. Gazdar, J. Griener, M. Landay, D. Mendelsohn, J. Tourville, P. Rogers, K. Y. Orr, J. McWhorter, D. P. Carbone

Research output: Contribution to journalArticle

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Abstract

Currently available therapies are unsatisfactory for locally advanced solid tumors of the lung, head and neck, and brain. Laboratory data suggest that the addition of paclitaxel (Taxol; Bristol-Myers Squibb Oncology, Princeton, NJ), a microtubule-stabilizing drug, to radiation therapy may result in significant radiation sensitization, perhaps because paclitaxel induces cell cycle arrest at G2/M. Relatively low concentrations, 1 to 10 nmol/L, appear to be optimal for direct cytotoxicity and radiosensitization in vitro. Within this dose range, more prolonged exposure seems to result in higher response rates. We are conducting phase I trials designed to test continuous infusion (24 hours per day, 7 days per week) intravenous paclitaxel combined with standard curative-intent radiation therapy. To date, 22 patients are evaluable, and the maximum tolerated dose of paclitaxel has not been reached at up to 2.5 mg/m2/d. Observed toxicities include anemia, lymphopenia, mucositis, and cutaneous erythema/desquamation.

Original languageEnglish (US)
Pages (from-to)13-17
Number of pages5
JournalSeminars in Oncology
Volume22
Issue number4 SUPPL. 9
StatePublished - 1995

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Paclitaxel
Radiotherapy
Neoplasms
G2 Phase Cell Cycle Checkpoints
Mucositis
Lymphopenia
Maximum Tolerated Dose
Erythema
Microtubules
Anemia
Neck
Head
Radiation
Lung
Skin
Brain
Pharmaceutical Preparations
Therapeutics

ASJC Scopus subject areas

  • Oncology

Cite this

Rosenthal, D. I., Close, L. G., Lucci, J. A., Schold, S. C., Truelson, J., Fathallah-Skaykh, H., ... Carbone, D. P. (1995). Phase I studies of continuous-infusion paclitaxel given with standard aggressive radiation therapy for locally advanced solid tumors. Seminars in Oncology, 22(4 SUPPL. 9), 13-17.

Phase I studies of continuous-infusion paclitaxel given with standard aggressive radiation therapy for locally advanced solid tumors. / Rosenthal, D. I.; Close, L. G.; Lucci, J. A.; Schold, S. C.; Truelson, J.; Fathallah-Skaykh, H.; Kamen, B.; Vultch, F. M.; Gazdar, A. F.; Griener, J.; Landay, M.; Mendelsohn, D.; Tourville, J.; Rogers, P.; Orr, K. Y.; McWhorter, J.; Carbone, D. P.

In: Seminars in Oncology, Vol. 22, No. 4 SUPPL. 9, 1995, p. 13-17.

Research output: Contribution to journalArticle

Rosenthal, DI, Close, LG, Lucci, JA, Schold, SC, Truelson, J, Fathallah-Skaykh, H, Kamen, B, Vultch, FM, Gazdar, AF, Griener, J, Landay, M, Mendelsohn, D, Tourville, J, Rogers, P, Orr, KY, McWhorter, J & Carbone, DP 1995, 'Phase I studies of continuous-infusion paclitaxel given with standard aggressive radiation therapy for locally advanced solid tumors', Seminars in Oncology, vol. 22, no. 4 SUPPL. 9, pp. 13-17.
Rosenthal, D. I. ; Close, L. G. ; Lucci, J. A. ; Schold, S. C. ; Truelson, J. ; Fathallah-Skaykh, H. ; Kamen, B. ; Vultch, F. M. ; Gazdar, A. F. ; Griener, J. ; Landay, M. ; Mendelsohn, D. ; Tourville, J. ; Rogers, P. ; Orr, K. Y. ; McWhorter, J. ; Carbone, D. P. / Phase I studies of continuous-infusion paclitaxel given with standard aggressive radiation therapy for locally advanced solid tumors. In: Seminars in Oncology. 1995 ; Vol. 22, No. 4 SUPPL. 9. pp. 13-17.
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AU - Close, L. G.

AU - Lucci, J. A.

AU - Schold, S. C.

AU - Truelson, J.

AU - Fathallah-Skaykh, H.

AU - Kamen, B.

AU - Vultch, F. M.

AU - Gazdar, A. F.

AU - Griener, J.

AU - Landay, M.

AU - Mendelsohn, D.

AU - Tourville, J.

AU - Rogers, P.

AU - Orr, K. Y.

AU - McWhorter, J.

AU - Carbone, D. P.

PY - 1995

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N2 - Currently available therapies are unsatisfactory for locally advanced solid tumors of the lung, head and neck, and brain. Laboratory data suggest that the addition of paclitaxel (Taxol; Bristol-Myers Squibb Oncology, Princeton, NJ), a microtubule-stabilizing drug, to radiation therapy may result in significant radiation sensitization, perhaps because paclitaxel induces cell cycle arrest at G2/M. Relatively low concentrations, 1 to 10 nmol/L, appear to be optimal for direct cytotoxicity and radiosensitization in vitro. Within this dose range, more prolonged exposure seems to result in higher response rates. We are conducting phase I trials designed to test continuous infusion (24 hours per day, 7 days per week) intravenous paclitaxel combined with standard curative-intent radiation therapy. To date, 22 patients are evaluable, and the maximum tolerated dose of paclitaxel has not been reached at up to 2.5 mg/m2/d. Observed toxicities include anemia, lymphopenia, mucositis, and cutaneous erythema/desquamation.

AB - Currently available therapies are unsatisfactory for locally advanced solid tumors of the lung, head and neck, and brain. Laboratory data suggest that the addition of paclitaxel (Taxol; Bristol-Myers Squibb Oncology, Princeton, NJ), a microtubule-stabilizing drug, to radiation therapy may result in significant radiation sensitization, perhaps because paclitaxel induces cell cycle arrest at G2/M. Relatively low concentrations, 1 to 10 nmol/L, appear to be optimal for direct cytotoxicity and radiosensitization in vitro. Within this dose range, more prolonged exposure seems to result in higher response rates. We are conducting phase I trials designed to test continuous infusion (24 hours per day, 7 days per week) intravenous paclitaxel combined with standard curative-intent radiation therapy. To date, 22 patients are evaluable, and the maximum tolerated dose of paclitaxel has not been reached at up to 2.5 mg/m2/d. Observed toxicities include anemia, lymphopenia, mucositis, and cutaneous erythema/desquamation.

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