A phase II trial of fixed dose rate gemcitabine in patients with advanced biliary tree carcinoma

Cathy Eng, Ramesh K. Ramathan, Michael K. Wong, Scot C. Remick, Lanting Dai, Kurombi T. Wade-Oliver, Sridhar Mani, Hedy L. Kindler

Research output: Contribution to journalArticle

38 Citations (Scopus)

Abstract

Gemcitabine is a commonly used chemotherapy for biliary tree carcinomas, achieving response rates of 10% to 60%. Preclinical studies indicate that fixed dose rate infusion optimizes accumulation of gemcitabine triphosphate and may enhance the clinical activity of gemcitabine. We conducted a phase II study of fixed dose rate gemcitabine in 15 chemotherapy-naive patients with advanced cholangiocarcinoma and gallbladder carcinoma. Gemcitabine was administered at a dose of 1500 mg/m2 over 150 minutes weekly for 3 weeks every 28 days. Fourteen patients were evaluable for response. No complete or partial responses were observed. Two patients (13%) had stable disease lasting a median of 9 weeks. The median time to progression was 9 weeks; median survival was 20 weeks. There was considerable grade 3/4 hematologic toxicity, including neutropenia in 49% of patients, leukopenia in 40%, anemia in 27%, and thrombocytopenia in 27%. Grade 3/4 nonhematologic toxicities were minimal. We conclude that fixed dose rate gemcitabine results in significant myelosuppression and has minimal activity in patients with biliary tree carcinoma.

Original languageEnglish (US)
Pages (from-to)565-569
Number of pages5
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume27
Issue number6
DOIs
StatePublished - Dec 2004
Externally publishedYes

Fingerprint

gemcitabine
Biliary Tract
Carcinoma
Drug Therapy
Cholangiocarcinoma
Leukopenia
Gallbladder
Neutropenia
Thrombocytopenia
Anemia
Survival

Keywords

  • Biliary carcinoma
  • Cholangiocarcinoma
  • Fixed rate infusion
  • Gallbladder carcinoma
  • Gemcitabine
  • Phase II trial

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

A phase II trial of fixed dose rate gemcitabine in patients with advanced biliary tree carcinoma. / Eng, Cathy; Ramathan, Ramesh K.; Wong, Michael K.; Remick, Scot C.; Dai, Lanting; Wade-Oliver, Kurombi T.; Mani, Sridhar; Kindler, Hedy L.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 27, No. 6, 12.2004, p. 565-569.

Research output: Contribution to journalArticle

Eng, Cathy ; Ramathan, Ramesh K. ; Wong, Michael K. ; Remick, Scot C. ; Dai, Lanting ; Wade-Oliver, Kurombi T. ; Mani, Sridhar ; Kindler, Hedy L. / A phase II trial of fixed dose rate gemcitabine in patients with advanced biliary tree carcinoma. In: American Journal of Clinical Oncology: Cancer Clinical Trials. 2004 ; Vol. 27, No. 6. pp. 565-569.
@article{3f3ddd1131654fe8890ccad9e70bebc8,
title = "A phase II trial of fixed dose rate gemcitabine in patients with advanced biliary tree carcinoma",
abstract = "Gemcitabine is a commonly used chemotherapy for biliary tree carcinomas, achieving response rates of 10{\%} to 60{\%}. Preclinical studies indicate that fixed dose rate infusion optimizes accumulation of gemcitabine triphosphate and may enhance the clinical activity of gemcitabine. We conducted a phase II study of fixed dose rate gemcitabine in 15 chemotherapy-naive patients with advanced cholangiocarcinoma and gallbladder carcinoma. Gemcitabine was administered at a dose of 1500 mg/m2 over 150 minutes weekly for 3 weeks every 28 days. Fourteen patients were evaluable for response. No complete or partial responses were observed. Two patients (13{\%}) had stable disease lasting a median of 9 weeks. The median time to progression was 9 weeks; median survival was 20 weeks. There was considerable grade 3/4 hematologic toxicity, including neutropenia in 49{\%} of patients, leukopenia in 40{\%}, anemia in 27{\%}, and thrombocytopenia in 27{\%}. Grade 3/4 nonhematologic toxicities were minimal. We conclude that fixed dose rate gemcitabine results in significant myelosuppression and has minimal activity in patients with biliary tree carcinoma.",
keywords = "Biliary carcinoma, Cholangiocarcinoma, Fixed rate infusion, Gallbladder carcinoma, Gemcitabine, Phase II trial",
author = "Cathy Eng and Ramathan, {Ramesh K.} and Wong, {Michael K.} and Remick, {Scot C.} and Lanting Dai and Wade-Oliver, {Kurombi T.} and Sridhar Mani and Kindler, {Hedy L.}",
year = "2004",
month = "12",
doi = "10.1097/01.coc.0000135924.94955.16",
language = "English (US)",
volume = "27",
pages = "565--569",
journal = "American Journal of Clinical Oncology",
issn = "0277-3732",
publisher = "Lippincott Williams and Wilkins",
number = "6",

}

TY - JOUR

T1 - A phase II trial of fixed dose rate gemcitabine in patients with advanced biliary tree carcinoma

AU - Eng, Cathy

AU - Ramathan, Ramesh K.

AU - Wong, Michael K.

AU - Remick, Scot C.

AU - Dai, Lanting

AU - Wade-Oliver, Kurombi T.

AU - Mani, Sridhar

AU - Kindler, Hedy L.

PY - 2004/12

Y1 - 2004/12

N2 - Gemcitabine is a commonly used chemotherapy for biliary tree carcinomas, achieving response rates of 10% to 60%. Preclinical studies indicate that fixed dose rate infusion optimizes accumulation of gemcitabine triphosphate and may enhance the clinical activity of gemcitabine. We conducted a phase II study of fixed dose rate gemcitabine in 15 chemotherapy-naive patients with advanced cholangiocarcinoma and gallbladder carcinoma. Gemcitabine was administered at a dose of 1500 mg/m2 over 150 minutes weekly for 3 weeks every 28 days. Fourteen patients were evaluable for response. No complete or partial responses were observed. Two patients (13%) had stable disease lasting a median of 9 weeks. The median time to progression was 9 weeks; median survival was 20 weeks. There was considerable grade 3/4 hematologic toxicity, including neutropenia in 49% of patients, leukopenia in 40%, anemia in 27%, and thrombocytopenia in 27%. Grade 3/4 nonhematologic toxicities were minimal. We conclude that fixed dose rate gemcitabine results in significant myelosuppression and has minimal activity in patients with biliary tree carcinoma.

AB - Gemcitabine is a commonly used chemotherapy for biliary tree carcinomas, achieving response rates of 10% to 60%. Preclinical studies indicate that fixed dose rate infusion optimizes accumulation of gemcitabine triphosphate and may enhance the clinical activity of gemcitabine. We conducted a phase II study of fixed dose rate gemcitabine in 15 chemotherapy-naive patients with advanced cholangiocarcinoma and gallbladder carcinoma. Gemcitabine was administered at a dose of 1500 mg/m2 over 150 minutes weekly for 3 weeks every 28 days. Fourteen patients were evaluable for response. No complete or partial responses were observed. Two patients (13%) had stable disease lasting a median of 9 weeks. The median time to progression was 9 weeks; median survival was 20 weeks. There was considerable grade 3/4 hematologic toxicity, including neutropenia in 49% of patients, leukopenia in 40%, anemia in 27%, and thrombocytopenia in 27%. Grade 3/4 nonhematologic toxicities were minimal. We conclude that fixed dose rate gemcitabine results in significant myelosuppression and has minimal activity in patients with biliary tree carcinoma.

KW - Biliary carcinoma

KW - Cholangiocarcinoma

KW - Fixed rate infusion

KW - Gallbladder carcinoma

KW - Gemcitabine

KW - Phase II trial

UR - http://www.scopus.com/inward/record.url?scp=10044298378&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=10044298378&partnerID=8YFLogxK

U2 - 10.1097/01.coc.0000135924.94955.16

DO - 10.1097/01.coc.0000135924.94955.16

M3 - Article

VL - 27

SP - 565

EP - 569

JO - American Journal of Clinical Oncology

JF - American Journal of Clinical Oncology

SN - 0277-3732

IS - 6

ER -