scholarly journals A phase 1 study of fixed dose rate gemcitabine and irinotecan in patients with advanced pancreatic and biliary cancer

Cancer ◽  
2007 ◽  
Vol 110 (12) ◽  
pp. 2768-2774 ◽  
Author(s):  
Weijing Sun ◽  
Maureen R. Hewitt ◽  
Marry R. Theobald ◽  
Diane Hershock ◽  
Daniel G. Haller
Keyword(s):  
Dose Rate ◽  
Phase 1 ◽  
Fixed Dose ◽  
Biliary Cancer ◽  
Phase 1 Study ◽  
Fixed Dose Rate

Fixed dose rate infusion of gemcitabine and UFT combination chemotherapy in patients with advanced biliary cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15581-e15581
Author(s):  
S. Lee ◽  
H. Ryoo ◽  
S. Bae ◽  
H. Song ◽  
M. Kim ◽  
...  
Keyword(s):  
Dna Repair ◽  
Dose Rate ◽  
Combination Chemotherapy ◽  
Advanced Pancreatic Cancer ◽  
Fixed Dose ◽  
Biliary Cancer ◽  
Repair Gene ◽  
Dna Repair Gene ◽  
Fixed Dose Rate ◽  
Grade 3

e15581 Background: Biliary cancer is diagnosed at advanced stage and recurrence is common after surgical resection. Gemcitabine and UFT combination chemotherapy showed promising results in advanced pancreatic cancer(APC) and fixed dose- rate(FDR) infusion(10mg/m2/min) of gemcitabine is more effective than 30min-infusion in APC patients. We conducted a prospective multicenter phase II study to evaluate the efficacy and toxicity of FDR gemcitabine and UFT combination chemotherapy in advanced biliary cancer(ABC) patients. We evaluated the quality of life(QOL) and relationship between treatment outcome and polymorphisms of DNA repair gene such as RecQ1, RAD54L, XRCC1 and ATM. Methods: We included the chemo-naive patients with measurable metastatic or recurrent biliary adenocarcinoma except gall bladder cancer. Patients received gemcitabine infusion of rate of 10mg/m2/min on day 1, 8, and 15 plus oral UFT (400mg/m2) on day 1 to 21. We used modified PCR-RFLP method to evaluate the polymorphism of DNA repair gene. The primary endpoint was response rate. Results: From October 2006 to March 2008, 47 patients were enrolled and 33 of them were included in this analysis. Median age was 58 years(range 33–73 years) and 18 patients were male. Partial response was 24.2% and disease control rate was 51.5%. The estimated median time to progression(TTP) was 87 days(95% CI 51–123). Median overall survival was 243 days(95% CI 114–372). Grade 3/4 neutropenia was observed in 12 of 33 patients(36.4%) and 17 times of 114 cycles of chemotherapy(14.9%). No febrile neutropenia was observed. Grade 3/4 thrombocytopenia occurred in 5 patients(15.2%). Non-hematologic toxicities were mild. Polymorphism of XRCC1 was related to TTP(TTP of wild, heterozygous variant and homozygous variant type was 162, 71 and 25 days, respectively. p=0.0039). QOL as a secondary endpoint was not analyzed at this time. Conclusions: FDR infusion of gemcitabine and UFT combination chemotherapy in chemo-naïve patients with ABC is a well-tolerated and effective regimen. No significant financial relationships to disclose.

Fixed dose-rate infusion of gemcitabine in combination with cisplatin and UFT in advanced carcinoma of the pancreas

2006 ◽  
Vol 58 (4) ◽  
pp. 419-426 ◽  
Author(s):  
J. Feliu ◽  
J. García Sáenz ◽  
A. Rodríguez Jaráiz ◽  
C. Castañón ◽  
M. Cruz ◽  
...  
Keyword(s):  
Dose Rate ◽  
Fixed Dose ◽  
Advanced Carcinoma ◽  
Carcinoma Of The Pancreas ◽  
Fixed Dose Rate ◽  
Fixed Dose Rate Infusion ◽  
Rate Infusion

Randomized Phase II Comparison of Dose-Intense Gemcitabine: Thirty-Minute Infusion and Fixed Dose Rate Infusion in Patients With Pancreatic Adenocarcinoma

2003 ◽  
Vol 21 (18) ◽  
pp. 3402-3408 ◽  
Author(s):  
Margaret Tempero ◽  
William Plunkett ◽  
Veronique Ruiz van Haperen ◽  
John Hainsworth ◽  
Howard Hochster ◽  
...  
Keyword(s):  
Treatment Failure ◽  
Dose Rate ◽  
Pancreatic Adenocarcinoma ◽  
Median Survival ◽  
Phase Ii ◽  
Fixed Dose ◽  
Time To Treatment ◽  
Randomized Phase Ii ◽  
Fixed Dose Rate ◽  
Time To Treatment Failure

Purpose: To conduct a randomized phase II trial of dose-intense gemcitabine using a standard 30-minute infusion or the fixed dose rate (FDR) infusion (10 mg/m2/min) in patients with pancreatic adenocarcinoma. Patients and Methods: In this prospective trial, patients with locally advanced and metastatic pancreatic adenocarcinoma were treated with 2,200 mg/m2 gemcitabine over 30 minutes (standard arm) or 1,500 mg/m2 gemcitabine over 150 minutes (FDR arm) on days 1, 8, and 15 of every 4-week cycle. The primary end point of this trial was time to treatment failure. Secondary end points included time to progression, median survival, safety, and pharmacokinetic studies of gemcitabine. Results: Ninety-two patients were enrolled onto this study; 91% of the patients had metastatic disease. Time to treatment failure was comparable in both treatment groups; however, the median survival for all patients was 5.0 months in the standard arm and 8.0 months in the FDR arm (P = .013). For patients with metastases, the median survival was 4.9 months in the standard arm and 7.3 months in FDR arm (P = .094). The 1- and 2-year survival rates for all patients were 9% (standard arm) versus 28.8% (FDR; P = .014) and 2.2% (standard arm) versus 18.3% (FDR; P = .007), respectively. Patients in the FDR infusion arm experienced consistently more hematologic toxicity. Pharmacokinetic analyses demonstrated a two-fold increase in intracellular gemcitabine triphosphate concentration in the FDR arm (P = .046). Conclusion: Pharmacokinetic and clinical data in this trial supports the continued evaluation of the FDR infusion strategy with gemcitabine.

EFFICACY AND FEASIBILITY OF A FIXED-DOSE RATE INFUSION OF LOW-DOSE GEMCITABINE IN PANCREATIC CANCER

Pancreas ◽  
2005 ◽  
Vol 31 (4) ◽  
pp. 431-432
Author(s):  
T Aimoto ◽  
E Uchida ◽  
Y Nakamura ◽  
A Katsuno ◽  
K Cho ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Dose Rate ◽  
Low Dose ◽  
Fixed Dose ◽  
Fixed Dose Rate ◽  
Fixed Dose Rate Infusion ◽  
Rate Infusion
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