Phase I study of pegylated liposomal doxorubicin and gemcitabine in patients with advanced malignancies

Paula M. Fracasso; Kristie A. Blum; Benjamin R. Tan; Carole L. Fears; Nancy L. Bartlett; Matthew A. Arquette; Romnee S. Clark

doi:10.1002/cncr.10937

Phase I study of pegylated liposomal doxorubicin and gemcitabine in patients with advanced malignancies

Paula M. Fracasso, Kristie A. Blum, Benjamin R. Tan, Carole L. Fears, Nancy L. Bartlett, Matthew A. Arquette, Romnee S. Clark

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11 Scopus citations

Abstract

BACKGROUND. Pegylated liposomal doxorubicin (PEG-LD) and gemcitabine have single-agent activity in breast and ovarian carcinoma patients. We conducted a Phase I trial to evaluate the maximum tolerated dose (MTD) and toxicities of this combination in patients with advanced malignancies. METHODS. Twenty-six patients with refractory or recurrent malignancies were enrolled in this dose escalation trial. Dose escalation proceeded from a starting level of PEG-LD 20 mg/m² and gemcitabine 1000 mg/m² administered on Days 1 and 15 of a 28-day cycle. RESULTS. The MTD was PEG-LD 20 mg/m² and gemcitabine 2000 mg/m² administered on Days 1 and 15 of a 28-day cycle. Dose-limiting toxicity, a Grade 3 rash, was observed in one patient during Cycle 1 and Grade 3 stomatitis and a rash were observed in a second patient during Cycle 2 after administration of PEG-LD 25 mg/m² and gemcitabine 2000 mg/m². Other side effects included palmar-plantar erythrodysesthesia, nausea, and fatigue. One complete and two partial responses were observed. CONCLUSIONS. The recommended Phase II dose is PEG-LD 20 mg/m² with gemcitabine 2000 mg/m² on Days 1 and 15 of a 28-day cycle. A trial with this combination is currently ongoing at this institution comprising patients with refractory ovarian carcinoma.

Original language	English
Pages (from-to)	2223-2229
Number of pages	7
Journal	Cancer
Volume	95
Issue number	10
DOIs	https://doi.org/10.1002/cncr.10937
State	Published - Nov 15 2002

Keywords

Doxil®
Gemcitabine
Gemzar®
Palmar-plantar erythrodysesthesia
Pegylated liposomal doxorubicin
Phase I

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10.1002/cncr.10937

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title = "Phase I study of pegylated liposomal doxorubicin and gemcitabine in patients with advanced malignancies",

abstract = "BACKGROUND. Pegylated liposomal doxorubicin (PEG-LD) and gemcitabine have single-agent activity in breast and ovarian carcinoma patients. We conducted a Phase I trial to evaluate the maximum tolerated dose (MTD) and toxicities of this combination in patients with advanced malignancies. METHODS. Twenty-six patients with refractory or recurrent malignancies were enrolled in this dose escalation trial. Dose escalation proceeded from a starting level of PEG-LD 20 mg/m2 and gemcitabine 1000 mg/m2 administered on Days 1 and 15 of a 28-day cycle. RESULTS. The MTD was PEG-LD 20 mg/m2 and gemcitabine 2000 mg/m2 administered on Days 1 and 15 of a 28-day cycle. Dose-limiting toxicity, a Grade 3 rash, was observed in one patient during Cycle 1 and Grade 3 stomatitis and a rash were observed in a second patient during Cycle 2 after administration of PEG-LD 25 mg/m2 and gemcitabine 2000 mg/m2. Other side effects included palmar-plantar erythrodysesthesia, nausea, and fatigue. One complete and two partial responses were observed. CONCLUSIONS. The recommended Phase II dose is PEG-LD 20 mg/m2 with gemcitabine 2000 mg/m2 on Days 1 and 15 of a 28-day cycle. A trial with this combination is currently ongoing at this institution comprising patients with refractory ovarian carcinoma.",

keywords = "Doxil{\textregistered}, Gemcitabine, Gemzar{\textregistered}, Palmar-plantar erythrodysesthesia, Pegylated liposomal doxorubicin, Phase I",

author = "Fracasso, {Paula M.} and Blum, {Kristie A.} and Tan, {Benjamin R.} and Fears, {Carole L.} and Bartlett, {Nancy L.} and Arquette, {Matthew A.} and Clark, {Romnee S.}",

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T1 - Phase I study of pegylated liposomal doxorubicin and gemcitabine in patients with advanced malignancies

AU - Fracasso, Paula M.

AU - Blum, Kristie A.

AU - Tan, Benjamin R.

AU - Fears, Carole L.

AU - Bartlett, Nancy L.

AU - Arquette, Matthew A.

AU - Clark, Romnee S.

PY - 2002/11/15

Y1 - 2002/11/15

N2 - BACKGROUND. Pegylated liposomal doxorubicin (PEG-LD) and gemcitabine have single-agent activity in breast and ovarian carcinoma patients. We conducted a Phase I trial to evaluate the maximum tolerated dose (MTD) and toxicities of this combination in patients with advanced malignancies. METHODS. Twenty-six patients with refractory or recurrent malignancies were enrolled in this dose escalation trial. Dose escalation proceeded from a starting level of PEG-LD 20 mg/m2 and gemcitabine 1000 mg/m2 administered on Days 1 and 15 of a 28-day cycle. RESULTS. The MTD was PEG-LD 20 mg/m2 and gemcitabine 2000 mg/m2 administered on Days 1 and 15 of a 28-day cycle. Dose-limiting toxicity, a Grade 3 rash, was observed in one patient during Cycle 1 and Grade 3 stomatitis and a rash were observed in a second patient during Cycle 2 after administration of PEG-LD 25 mg/m2 and gemcitabine 2000 mg/m2. Other side effects included palmar-plantar erythrodysesthesia, nausea, and fatigue. One complete and two partial responses were observed. CONCLUSIONS. The recommended Phase II dose is PEG-LD 20 mg/m2 with gemcitabine 2000 mg/m2 on Days 1 and 15 of a 28-day cycle. A trial with this combination is currently ongoing at this institution comprising patients with refractory ovarian carcinoma.

AB - BACKGROUND. Pegylated liposomal doxorubicin (PEG-LD) and gemcitabine have single-agent activity in breast and ovarian carcinoma patients. We conducted a Phase I trial to evaluate the maximum tolerated dose (MTD) and toxicities of this combination in patients with advanced malignancies. METHODS. Twenty-six patients with refractory or recurrent malignancies were enrolled in this dose escalation trial. Dose escalation proceeded from a starting level of PEG-LD 20 mg/m2 and gemcitabine 1000 mg/m2 administered on Days 1 and 15 of a 28-day cycle. RESULTS. The MTD was PEG-LD 20 mg/m2 and gemcitabine 2000 mg/m2 administered on Days 1 and 15 of a 28-day cycle. Dose-limiting toxicity, a Grade 3 rash, was observed in one patient during Cycle 1 and Grade 3 stomatitis and a rash were observed in a second patient during Cycle 2 after administration of PEG-LD 25 mg/m2 and gemcitabine 2000 mg/m2. Other side effects included palmar-plantar erythrodysesthesia, nausea, and fatigue. One complete and two partial responses were observed. CONCLUSIONS. The recommended Phase II dose is PEG-LD 20 mg/m2 with gemcitabine 2000 mg/m2 on Days 1 and 15 of a 28-day cycle. A trial with this combination is currently ongoing at this institution comprising patients with refractory ovarian carcinoma.

KW - Doxil®

KW - Gemcitabine

KW - Gemzar®

KW - Palmar-plantar erythrodysesthesia

KW - Pegylated liposomal doxorubicin

KW - Phase I

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JO - Cancer

JF - Cancer

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ER -

Phase I study of pegylated liposomal doxorubicin and gemcitabine in patients with advanced malignancies

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Keywords

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