A phase II trial of gemcitabine in combination with 5-fluorouracil (24-hour) and folinic acid in patients with chemonaive advanced pancreatic cancer

Oettle, Helmut; Arning, M.; Pelzer, Uwe; Arnold, Dirk; Stroszczyński, C.; Langrehr, Jan M.; Reitzig, P; Kindler, M.; Herrenberger, Julia; Musch, R; Korsten, F. W.; Huhn, D.; Riess, Hanno

doi:10.1023/a:1008364018881

Cited by 51 publications

(26 citation statements)

References 23 publications

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“…Based on the complementary pharmacology of their mechanisms of action, the combination of 5-FU and gemcitabine was evaluated in many phase I and II trials. The interpretation of results suggested a clinical activity of the association schedule with a good tolerability (19)(20)(21)(22).…”

Section: Gemcitabine-combined Regimensmentioning

confidence: 89%

Metastatic pancreatic cancer: Is gemcitabine still the best standard treatment? (Review)

Marco¹

2010

Oncol Rep

118

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Abstract. Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. Surgery remains the only treatment offering an advantage in terms of overall survival (5-year survival range, 15-25%), but unfortunately only 10-20% of patients present resectable disease at the time of diagnosis. Hence chemotherapy, possibly combined with radiation therapy, remains the only treatment option aimed at palliation of symptoms and ensuring a better quality of life. Notwithstanding the efforts to find more effective therapies for the treatment of pancreatic cancer, significant results have not yet been achieved. Increasing interest has focused on integrated treatments, i.e. chemotherapy combined with targeted therapies, and a better selection of patients. This study examines the principal clinical trials that will help give clinicians an overview of the progress made in the systemic therapy for advanced pancreatic cancer patients in recent years.

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Section: Gemcitabine-combined Regimensmentioning

confidence: 89%

Metastatic pancreatic cancer: Is gemcitabine still the best standard treatment? (Review)

Marco¹

2010

Oncol Rep

118

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“…The complete response has continued for 36 months after the initial surgery. , 1996), leucovorin (Oman, Blind, Naredi et al, 2001;Huguier, Barrier, Valinas et al, 2001;Oettle, Arning, Pelzer et al, 2000;Andre, Balosso, Louvet et al, 2000;Kornek, Schratter-Sehn, Marczell et al, 2000;Link, Formentini, Papachristov et al, 1997;Raderer, Kornek, Hejna et al, 1997) and interferons were used with 5-FU as biochemical modulators, and epirubicin (Raderer , Kornek, Hejna et al, 1997), mitomycin, cyclophosphamide and many other agents were used in an attempt to gain synergistic effects . Weekly 5-FU with leucovorin, daily dipyridamole and intermittent mitomycin-C was reported to be effective palliative, neoadjuvant and adjuvant chemotherapy for pancreatic cancer Todd, Gloor, Lane et al, 1998).…”

Section: Resultsmentioning

confidence: 99%

“…Systemic chemotherapy is an alternative treatment for patients with advanced and unresectable pancreatic cancer and many clinical trials have been performed in an attempt to find the optimal anti-cancer drug regimen. The combination of 5-FU and leucovorin has been shown to have some anti-cancer effect in patients with advanced gastrointestinal and pancreatic cancer (Oman, Blind, Naredi et al, 2001;Huguier, Barrier, Valinas et al, 2001;Oettle, Arning, Pelzer et al, 2000;Andre, Balosso, Louvet et al, 2000;Kornek, Schratter-Sehn, Marczell et al, 2000). However, the results for pancreatic cancer were far from satisfactory with a maximal response rate of 20-30% with either mono-or combination therapy.…”

Section: Introductionmentioning

confidence: 99%

Treatment of Non-Resectable Pancreatic Cancer With 5-Fluorouracil, Leucovorin and Mitomycin-C

Sata

Koizumi

Tsukahara

et al. 2003

ACRT

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Pancreatic cancer has a dismal prognosis because most lesions are unresectable where as adjuvant and palliative chemotherapy exhibits poor results.Six patients with locally unresectable pancreatic cancer were treated with mitomycin-C (MMC) 8mg/m2 on day 1 and 5-FU 375mg/m2 and LV 20mg/m2 on days 1 to 5. Treatment cycles were repeated every four weeks if the patient's general condition permitted. All patients had measurable, histologically proven adenocarcinoma and had not undergone prior chemotherapy.

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“…Clinical studies have reported activity of gemcitabine in pancreatic cancer patients with refractoriness to 5-FU [27], suggesting the lack of cross-resistance between the two agents. Several phase I and II studies of combination therapy with gemcitabine and 5-FU for advanced pancreatic cancer have demonstrated relatively good response rates of around 20% with acceptable toxicity profiles [14,15,16,17,18]. A phase III study comparing gemcitabine alone with gemcitabine plus weekly bolus 5-FU showed that median progression-free survival was significantly longer in the combination arm compared with gemcitabine alone (3.4 vs. 2.2 months, p = 0.022); however, median overall survival was not significantly prolonged (6.7 vs. 5.4 months, p = 0.09) [5].…”

Section: Discussionmentioning

confidence: 99%

A Phase I Study of Combination Chemotherapy with Gemcitabine and Oral S-1 for Advanced Pancreatic Cancer

et al. 2005

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Objective: The aim of this study was to determine the maximum-tolerated dose and dose-limiting toxicity (DLT) of combination therapy with gemcitabine and S-1 in patients with advanced pancreatic cancer. Methods: Chemotherapy-naive patients with histologically or cytologically proven unresectable or metastatic pancreatic cancer were enrolled. The patients received gemcitabine intravenously over 30 min on days 1 and 8 and S-1 orally twice daily from days 1 to 14. Cycles were repeated every 21 days until disease progression. Patients were scheduled to receive gemcitabine (mg/m²/week) and S-1 (mg/m²/day) at four dose levels: 800/60 (level 1), 1,000/60 (level 2), 1,000/70 (level 3) and 1,000/80 (level 4). Results: Eighteen patients were enrolled in this study. The maximum-tolerated dose was not reached even at the highest dose level (level 4) because only 2 of the 6 patients at this level experienced DLT. The DLTs were neutropenia and rash. Six (33%) of the 18 patients achieved a partial response and median overall survival time was 7.6 months. Conclusions: Combination chemotherapy with gemcitabine and S-1 was well tolerated and showed good antitumor activity in the treatment of pancreatic cancer. We recommend a gemcitabine dose of 1,000 mg/m²/week and an S-1 dose of 80 mg/m²/day in further studies with this schedule.

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A phase II trial of gemcitabine in combination with 5-fluorouracil (24-hour) and folinic acid in patients with chemonaive advanced pancreatic cancer

Abstract: The combination of gemcitabine and 5-FU-FA is active and well tolerated and seems to offer an improvement in progression-free interval over both gemcitabine monotherapy and 5-FU-FA therapy.

Cited by 51 publications

References 23 publications

Metastatic pancreatic cancer: Is gemcitabine still the best standard treatment? (Review)

Metastatic pancreatic cancer: Is gemcitabine still the best standard treatment? (Review)

Treatment of Non-Resectable Pancreatic Cancer With 5-Fluorouracil, Leucovorin and Mitomycin-C

A Phase I Study of Combination Chemotherapy with Gemcitabine and Oral S-1 for Advanced Pancreatic Cancer

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