Phase I study of biweekly gemcitabine followed by oxaliplatin and simplified 48-h infusion of fluorouracil/leucovorin for advanced pancreatic cancer

Hui Ju Ch'ang, Chuan Cheng Wang, Ann Lii Cheng, Chiun Hsu, Yen Shen Lu, Ming Chu Chang, Jaw Town Lin, Hsiu Po Wang, Her Shyong Shiah, Tsang Wu Liu, Jang Yang Chang, Jacqueline Whang-Peng, Li Tzong Chen

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Objectives: To evaluate the feasibility and maximal tolerated dose (MTD) of oxaliplatin of a triplet regimen consisting of gemcitabine, oxaliplatin and infusional fluorouracil (5-FU)/leucovorin (LV) (GOFL) for advanced pancreatic cancer. Patients and Methods: Patients with histologically proven metastatic or unresectable, locally advanced pancreatic adenocarcinoma were eligible to take part in the study. The treatment consisted of fixed-rate infusion (10 mg/m 2/minute) of 800 mg/m2 gemcitabine followed by 2-h infusion of oxaliplatin and then 48-h infusion of 5-FU/LV day 1 and day 15 every 4 weeks. The oxaliplatin would be evaluated at three dose levels, 65, 75 and 85 mg/m2. Results: A total of 15 patients were enrolled at three dose levels. Dose-limiting toxicity of neutropenic fever and grade 4 thrombocytopenia occurred in one of each six patients at oxaliplatin dose level of 65 mg/m 2 and 85 mg/m2, respectively. The MTD of oxaliplatin for this combination was 85 mg/m2. After a median four cycles of treatment, grade 3/4 neutropenia occurred in 46.7% of patients and thrombocytopenia in 13.3%. Non-hematological toxicities were generally of grade 1/2. Objective tumor response was observed in five patients (33.3%, 95% confidence interval, 6.3-60.4%). Conclusion: Biweekly GOFL is a feasible regimen for advanced pancreatic cancer. For further phase II studies, the recommended dose of oxaliplatin is 85 mg/m2.

Original languageEnglish
Pages (from-to)874-879
Number of pages6
JournalJournal of Gastroenterology and Hepatology (Australia)
Volume21
Issue number5
DOIs
Publication statusPublished - Jan 1 2006
Externally publishedYes

Fingerprint

oxaliplatin
gemcitabine
Leucovorin
Pancreatic Neoplasms
Fluorouracil
Maximum Tolerated Dose
Neutropenia
Thrombocytopenia
Adenocarcinoma
Fever

Keywords

  • Gemcitabine
  • Infusional fluorouracil
  • Oxaliplatin
  • Pancreatic cancer
  • Phase I

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Phase I study of biweekly gemcitabine followed by oxaliplatin and simplified 48-h infusion of fluorouracil/leucovorin for advanced pancreatic cancer. / Ch'ang, Hui Ju; Wang, Chuan Cheng; Cheng, Ann Lii; Hsu, Chiun; Lu, Yen Shen; Chang, Ming Chu; Lin, Jaw Town; Wang, Hsiu Po; Shiah, Her Shyong; Liu, Tsang Wu; Chang, Jang Yang; Whang-Peng, Jacqueline; Chen, Li Tzong.

In: Journal of Gastroenterology and Hepatology (Australia), Vol. 21, No. 5, 01.01.2006, p. 874-879.

Research output: Contribution to journalArticle

Ch'ang, Hui Ju ; Wang, Chuan Cheng ; Cheng, Ann Lii ; Hsu, Chiun ; Lu, Yen Shen ; Chang, Ming Chu ; Lin, Jaw Town ; Wang, Hsiu Po ; Shiah, Her Shyong ; Liu, Tsang Wu ; Chang, Jang Yang ; Whang-Peng, Jacqueline ; Chen, Li Tzong. / Phase I study of biweekly gemcitabine followed by oxaliplatin and simplified 48-h infusion of fluorouracil/leucovorin for advanced pancreatic cancer. In: Journal of Gastroenterology and Hepatology (Australia). 2006 ; Vol. 21, No. 5. pp. 874-879.
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abstract = "Objectives: To evaluate the feasibility and maximal tolerated dose (MTD) of oxaliplatin of a triplet regimen consisting of gemcitabine, oxaliplatin and infusional fluorouracil (5-FU)/leucovorin (LV) (GOFL) for advanced pancreatic cancer. Patients and Methods: Patients with histologically proven metastatic or unresectable, locally advanced pancreatic adenocarcinoma were eligible to take part in the study. The treatment consisted of fixed-rate infusion (10 mg/m 2/minute) of 800 mg/m2 gemcitabine followed by 2-h infusion of oxaliplatin and then 48-h infusion of 5-FU/LV day 1 and day 15 every 4 weeks. The oxaliplatin would be evaluated at three dose levels, 65, 75 and 85 mg/m2. Results: A total of 15 patients were enrolled at three dose levels. Dose-limiting toxicity of neutropenic fever and grade 4 thrombocytopenia occurred in one of each six patients at oxaliplatin dose level of 65 mg/m 2 and 85 mg/m2, respectively. The MTD of oxaliplatin for this combination was 85 mg/m2. After a median four cycles of treatment, grade 3/4 neutropenia occurred in 46.7{\%} of patients and thrombocytopenia in 13.3{\%}. Non-hematological toxicities were generally of grade 1/2. Objective tumor response was observed in five patients (33.3{\%}, 95{\%} confidence interval, 6.3-60.4{\%}). Conclusion: Biweekly GOFL is a feasible regimen for advanced pancreatic cancer. For further phase II studies, the recommended dose of oxaliplatin is 85 mg/m2.",
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T1 - Phase I study of biweekly gemcitabine followed by oxaliplatin and simplified 48-h infusion of fluorouracil/leucovorin for advanced pancreatic cancer

AU - Ch'ang, Hui Ju

AU - Wang, Chuan Cheng

AU - Cheng, Ann Lii

AU - Hsu, Chiun

AU - Lu, Yen Shen

AU - Chang, Ming Chu

AU - Lin, Jaw Town

AU - Wang, Hsiu Po

AU - Shiah, Her Shyong

AU - Liu, Tsang Wu

AU - Chang, Jang Yang

AU - Whang-Peng, Jacqueline

AU - Chen, Li Tzong

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N2 - Objectives: To evaluate the feasibility and maximal tolerated dose (MTD) of oxaliplatin of a triplet regimen consisting of gemcitabine, oxaliplatin and infusional fluorouracil (5-FU)/leucovorin (LV) (GOFL) for advanced pancreatic cancer. Patients and Methods: Patients with histologically proven metastatic or unresectable, locally advanced pancreatic adenocarcinoma were eligible to take part in the study. The treatment consisted of fixed-rate infusion (10 mg/m 2/minute) of 800 mg/m2 gemcitabine followed by 2-h infusion of oxaliplatin and then 48-h infusion of 5-FU/LV day 1 and day 15 every 4 weeks. The oxaliplatin would be evaluated at three dose levels, 65, 75 and 85 mg/m2. Results: A total of 15 patients were enrolled at three dose levels. Dose-limiting toxicity of neutropenic fever and grade 4 thrombocytopenia occurred in one of each six patients at oxaliplatin dose level of 65 mg/m 2 and 85 mg/m2, respectively. The MTD of oxaliplatin for this combination was 85 mg/m2. After a median four cycles of treatment, grade 3/4 neutropenia occurred in 46.7% of patients and thrombocytopenia in 13.3%. Non-hematological toxicities were generally of grade 1/2. Objective tumor response was observed in five patients (33.3%, 95% confidence interval, 6.3-60.4%). Conclusion: Biweekly GOFL is a feasible regimen for advanced pancreatic cancer. For further phase II studies, the recommended dose of oxaliplatin is 85 mg/m2.

AB - Objectives: To evaluate the feasibility and maximal tolerated dose (MTD) of oxaliplatin of a triplet regimen consisting of gemcitabine, oxaliplatin and infusional fluorouracil (5-FU)/leucovorin (LV) (GOFL) for advanced pancreatic cancer. Patients and Methods: Patients with histologically proven metastatic or unresectable, locally advanced pancreatic adenocarcinoma were eligible to take part in the study. The treatment consisted of fixed-rate infusion (10 mg/m 2/minute) of 800 mg/m2 gemcitabine followed by 2-h infusion of oxaliplatin and then 48-h infusion of 5-FU/LV day 1 and day 15 every 4 weeks. The oxaliplatin would be evaluated at three dose levels, 65, 75 and 85 mg/m2. Results: A total of 15 patients were enrolled at three dose levels. Dose-limiting toxicity of neutropenic fever and grade 4 thrombocytopenia occurred in one of each six patients at oxaliplatin dose level of 65 mg/m 2 and 85 mg/m2, respectively. The MTD of oxaliplatin for this combination was 85 mg/m2. After a median four cycles of treatment, grade 3/4 neutropenia occurred in 46.7% of patients and thrombocytopenia in 13.3%. Non-hematological toxicities were generally of grade 1/2. Objective tumor response was observed in five patients (33.3%, 95% confidence interval, 6.3-60.4%). Conclusion: Biweekly GOFL is a feasible regimen for advanced pancreatic cancer. For further phase II studies, the recommended dose of oxaliplatin is 85 mg/m2.

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