Pemetrexed and gemcitabine for biliary tract and gallbladder carcinomas: A north central cancer treatment group (NCCTG) phase i and II trial, N9943

Steven R. Alberts, Jonathan R. Sande, Nathan R. Foster, Fernando J. Quevedo, Robert R. McWilliams, John W. Kugler, Tom R. Fitch, Anthony J. Jaslowski

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Purpose: To determine the maximum tolerated dose (MTD) and efficacy of pemetrexed and gemcitabine in patients with either biliary tract or gallbladder carcinoma. Patients and Methods: Patients with unresectable previously untreated biliary tract cancers were eligible for participation. An initial phase I trial was performed to determine the MTD using an every-2-weeks schedule. The MTD was then used in the phase II portion of the trial. The primary end point for the phase II portion was 6-month survival with a planned accrual of 59 patients. Results: Overall, 63 eligible patients were enrolled. The MTD was established as pemetrexed 500 mg/m2 IV over 10 min and gemcitabine 800 mg/m 2 IV at 10 mg/m2 per minute on days 1 and 15 of an every-4-weeks schedule with vitamin B12 and folate supplementation. Fifty-eight patients were included in the phase II portion. Median age was 61 and median follow-up was 18.2 months. A median of three cycles of treatment was given. Six-month survival was 55% and the median survival was 6.6 months (95% confidence interval 5.4-8.7 months) with a median time to progression of 3.8 months (2.4-5.4). Forty-seven (81%) experienced at least one grade 3+ adverse event, and 28 patients (48%) experienced at least one grade 4 adverse event, most of which were due to grade 4 neutropenia. Conclusion: The addition of pemetrexed to fixed-dose-rate gemcitabine, in a biweekly schedule, did not enhance the activity of gemcitabine in patients with biliary tract or gallbladder carcinoma.

Original languageEnglish (US)
Pages (from-to)87-94
Number of pages8
JournalJournal of Gastrointestinal Cancer
Volume38
Issue number2-4
DOIs
StatePublished - Dec 2007

Fingerprint

gemcitabine
Pemetrexed
Biliary Tract
Gallbladder
Carcinoma
Maximum Tolerated Dose
Neoplasms
Appointments and Schedules
Therapeutics
Survival
Biliary Tract Neoplasms
Vitamin B 12
Neutropenia
Folic Acid

Keywords

  • Biliary tract cancer
  • Clinical trial
  • Gallbladder cancer
  • Gemcitabine
  • Pemetrexed

ASJC Scopus subject areas

  • Gastroenterology
  • Oncology

Cite this

Pemetrexed and gemcitabine for biliary tract and gallbladder carcinomas : A north central cancer treatment group (NCCTG) phase i and II trial, N9943. / Alberts, Steven R.; Sande, Jonathan R.; Foster, Nathan R.; Quevedo, Fernando J.; McWilliams, Robert R.; Kugler, John W.; Fitch, Tom R.; Jaslowski, Anthony J.

In: Journal of Gastrointestinal Cancer, Vol. 38, No. 2-4, 12.2007, p. 87-94.

Research output: Contribution to journalArticle

Alberts, Steven R. ; Sande, Jonathan R. ; Foster, Nathan R. ; Quevedo, Fernando J. ; McWilliams, Robert R. ; Kugler, John W. ; Fitch, Tom R. ; Jaslowski, Anthony J. / Pemetrexed and gemcitabine for biliary tract and gallbladder carcinomas : A north central cancer treatment group (NCCTG) phase i and II trial, N9943. In: Journal of Gastrointestinal Cancer. 2007 ; Vol. 38, No. 2-4. pp. 87-94.
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abstract = "Purpose: To determine the maximum tolerated dose (MTD) and efficacy of pemetrexed and gemcitabine in patients with either biliary tract or gallbladder carcinoma. Patients and Methods: Patients with unresectable previously untreated biliary tract cancers were eligible for participation. An initial phase I trial was performed to determine the MTD using an every-2-weeks schedule. The MTD was then used in the phase II portion of the trial. The primary end point for the phase II portion was 6-month survival with a planned accrual of 59 patients. Results: Overall, 63 eligible patients were enrolled. The MTD was established as pemetrexed 500 mg/m2 IV over 10 min and gemcitabine 800 mg/m 2 IV at 10 mg/m2 per minute on days 1 and 15 of an every-4-weeks schedule with vitamin B12 and folate supplementation. Fifty-eight patients were included in the phase II portion. Median age was 61 and median follow-up was 18.2 months. A median of three cycles of treatment was given. Six-month survival was 55{\%} and the median survival was 6.6 months (95{\%} confidence interval 5.4-8.7 months) with a median time to progression of 3.8 months (2.4-5.4). Forty-seven (81{\%}) experienced at least one grade 3+ adverse event, and 28 patients (48{\%}) experienced at least one grade 4 adverse event, most of which were due to grade 4 neutropenia. Conclusion: The addition of pemetrexed to fixed-dose-rate gemcitabine, in a biweekly schedule, did not enhance the activity of gemcitabine in patients with biliary tract or gallbladder carcinoma.",
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T2 - A north central cancer treatment group (NCCTG) phase i and II trial, N9943

AU - Alberts, Steven R.

AU - Sande, Jonathan R.

AU - Foster, Nathan R.

AU - Quevedo, Fernando J.

AU - McWilliams, Robert R.

AU - Kugler, John W.

AU - Fitch, Tom R.

AU - Jaslowski, Anthony J.

PY - 2007/12

Y1 - 2007/12

N2 - Purpose: To determine the maximum tolerated dose (MTD) and efficacy of pemetrexed and gemcitabine in patients with either biliary tract or gallbladder carcinoma. Patients and Methods: Patients with unresectable previously untreated biliary tract cancers were eligible for participation. An initial phase I trial was performed to determine the MTD using an every-2-weeks schedule. The MTD was then used in the phase II portion of the trial. The primary end point for the phase II portion was 6-month survival with a planned accrual of 59 patients. Results: Overall, 63 eligible patients were enrolled. The MTD was established as pemetrexed 500 mg/m2 IV over 10 min and gemcitabine 800 mg/m 2 IV at 10 mg/m2 per minute on days 1 and 15 of an every-4-weeks schedule with vitamin B12 and folate supplementation. Fifty-eight patients were included in the phase II portion. Median age was 61 and median follow-up was 18.2 months. A median of three cycles of treatment was given. Six-month survival was 55% and the median survival was 6.6 months (95% confidence interval 5.4-8.7 months) with a median time to progression of 3.8 months (2.4-5.4). Forty-seven (81%) experienced at least one grade 3+ adverse event, and 28 patients (48%) experienced at least one grade 4 adverse event, most of which were due to grade 4 neutropenia. Conclusion: The addition of pemetrexed to fixed-dose-rate gemcitabine, in a biweekly schedule, did not enhance the activity of gemcitabine in patients with biliary tract or gallbladder carcinoma.

AB - Purpose: To determine the maximum tolerated dose (MTD) and efficacy of pemetrexed and gemcitabine in patients with either biliary tract or gallbladder carcinoma. Patients and Methods: Patients with unresectable previously untreated biliary tract cancers were eligible for participation. An initial phase I trial was performed to determine the MTD using an every-2-weeks schedule. The MTD was then used in the phase II portion of the trial. The primary end point for the phase II portion was 6-month survival with a planned accrual of 59 patients. Results: Overall, 63 eligible patients were enrolled. The MTD was established as pemetrexed 500 mg/m2 IV over 10 min and gemcitabine 800 mg/m 2 IV at 10 mg/m2 per minute on days 1 and 15 of an every-4-weeks schedule with vitamin B12 and folate supplementation. Fifty-eight patients were included in the phase II portion. Median age was 61 and median follow-up was 18.2 months. A median of three cycles of treatment was given. Six-month survival was 55% and the median survival was 6.6 months (95% confidence interval 5.4-8.7 months) with a median time to progression of 3.8 months (2.4-5.4). Forty-seven (81%) experienced at least one grade 3+ adverse event, and 28 patients (48%) experienced at least one grade 4 adverse event, most of which were due to grade 4 neutropenia. Conclusion: The addition of pemetrexed to fixed-dose-rate gemcitabine, in a biweekly schedule, did not enhance the activity of gemcitabine in patients with biliary tract or gallbladder carcinoma.

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KW - Clinical trial

KW - Gallbladder cancer

KW - Gemcitabine

KW - Pemetrexed

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