A phase II trial of paclitaxel and weekly 24 h infusion of 5-fluorouracil/folinic acid in patients with advanced gastric cancer

Bokemeyer, Carsten; Lampe, Christine; Clemens, Michael; Hartmann, Jörg T.; Quietzsch, Detlev; Forkmann, Lutz; Kollmannsberger, Christian; Kanz, Lothar

doi:10.1097/00001813-199704000-00014

Cited by 52 publications

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“…The median overall and progression-free survival of 14 and 9 months duration, respectively, in the current study are encouraging. The addition of cisplatin to our previous regimen consisting of paclitaxel and 5-FU/folinic acid appears to improve the overall response rate, in particular the number of complete responses and the median survival time (Bokemeyer et al, 1997b).…”

Section: Discussionmentioning

confidence: 95%

“…An additive cytotoxic effect has been reported in vitro for the sequence of paclitaxel followed by 5-FU whereas the exposure to 5-FU followed by paclitaxel showed subadditive effects (Kano et al, 1996). Based on these rationale we had previously performed a phase II trial examining the efficacy and toxicity of the combination of paclitaxel, 5-FU and folinic acid in 22 patients with chemonaive gastric cancer (Bokemeyer et al, 1997a). A response rate of 32% and a median overall survival of 11 months were achieved.…”

Section: Discussionmentioning

confidence: 98%

“…Studies investigating the combination of paclitaxel with 5-FU revealed response rates between 15 and 50%, associated with a rather low toxicity profile (Cascinu et al, 1997;Murad, 1999). We have reported the results for the combination of 5-FU given as a weekly 24-hour continuous infusion plus folinic acid for 6 consecutive weeks in combination with paclitaxel at 3 weekly intervals (Bokemeyer et al, 1997a). A response rate of 32% was observed in 22 chemonaive gastric cancer patients resulting in a progression-free and overall survival of 8 and 11 months, respectively.…”

mentioning

confidence: 99%

“…A response rate of 32% was observed in 22 chemonaive gastric cancer patients resulting in a progression-free and overall survival of 8 and 11 months, respectively. Toxicity was mild with neutropenia (14%), alopecia (45%) and nausea and vomiting (5%) being the most frequent WHO grade III/IV toxicities (Bokemeyer et al, 1997a).…”

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A phase II study of paclitaxel, weekly, 24-hour continuous infusion 5-fluorouracil, folinic acid and cisplatin in patients with advanced gastric cancer

et al. 2000

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SummaryTo evaluate the toxicity and efficacy of combination chemotherapy with paclitaxel, cisplatin and 24 h continuous infusion of 5-FU/folinic acid in patients (pts) with unresectable, locally advanced or metastatic gastric adenocarcinoma. Forty-five chemotherapy-naive pts (28 male and 17 female) with a median age of 60 years (range 35-74) were enrolled. 5-FU 2 g/m 2 was given weekly over 24 h i.v. preceded by folinic acid 500 mg/m 2 as a 2 h infusion. Paclitaxel 175 mg/m 2 was administered as a 3 h-infusion on days 1 and 22 and cisplatin 50 mg/m 2 as 1 h infusion on days 8 and 29. Six weeks of therapy (days 1, 8, 15, 22, 29, 36) followed by 2 weeks rest were considered one cycle. A median of 3 cycles (range 1-4) were administered to 45 pts assessable for response, survival and toxicity. Five pts (11%) obtained a CR and 18 pts (40%) a PR (ORR 51%; 95% Cl: 35.8-66.3%). Responses were achieved in the liver, lymph nodes, lungs and at the site of the primary tumour. Nine pts (20%) had stable disease. Thirteen pts (29%) were considered to have failed treatment, 8 pts (18%) due to progressive disease and 5 pts (11%) who did not receive one complete cycle of therapy due to acute non-haematologic toxicity. The median progression-free and overall survival times were 9 months (range 1-36+) and 14 months (range 2-36+), respectively. Neutropenia WHO III°/IV°occurred in 7 pts (15%) with only 1 pt having grade IV. Additional non-haematologic WHO III°/IV°toxicities included nausea/vomiting in 5 (11%), alopecia in 22 (49%), and diarrhoea in 1 patient each (2%). Dose reductions or treatment delays were necessary in 8 pts (17%), mainly due to neutropenia. All pts were treated on an outpatient basis. The combination of paclitaxel, cisplatin and continuously infused 5-FU/folinic acid appears to be a highly active regimen for the treatment of pts with advanced gastric cancer. While the overall acceptable toxicity allows its use in the palliative setting, it may also be an attractive option to be tested for neoadjuvant or adjuvant treatment.

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Section: Discussionmentioning

confidence: 95%

Section: Discussionmentioning

confidence: 98%

mentioning

confidence: 99%

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confidence: 99%

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A phase II study of paclitaxel, weekly, 24-hour continuous infusion 5-fluorouracil, folinic acid and cisplatin in patients with advanced gastric cancer

et al. 2000

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“…The second reason for combining paclitaxel with 5-FU is that their principal toxicities differ considerably. Neuropathy and neutropenia are the principal toxicities of paclitaxel, whereas stomatitis and diarrhoea are the predominant toxicities of fluoropyrimidines in most commonly used regimens (Bokemeyer et al, 1997;Cascinu et al, 1998). We therefore combined paclitaxel with S-1.…”

Section: Discussionmentioning

confidence: 99%

Phase I/II study of S-1 combined with paclitaxel in patients with unresectable and/or recurrent advanced gastric cancer

et al. 2006

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Both paclitaxel and S-1 are effective against gastric cancer, but the optimal regimen for combined chemotherapy with these drugs remains unclear. This phase I/II study was designed to determine the maximum tolerated dose (MTD), recommended dose (RD), dose-limiting toxicity (DLT), and objective response rate of paclitaxel in combination with S-1. S-1 was administered orally at a fixed dose of 80 mg m À2 day À1 from days 1 to 14 of a 28-day cycle. Paclitaxel was given intravenously on days 1, 8, and 15, starting with a dose of 40 mg m À2 day À1 . The dose was increased in a stepwise manner to 70 mg m À2 . Treatment was repeated every 4 weeks unless disease progression was confirmed. In the phase I portion, 17 patients were enrolled. The MTD of paclitaxel was estimated to be 70 mg m À2 because 40% of the patients given this dose level (two of five) had DLT. The RD was determined to be 60 mg m À2 . In the phase II portion, 24 patients, including five with assessable disease who received the RD in the phase I portion, were evaluated. The median number of treatment courses was six (range: 1 -17). The incidence of the worst-grade toxicity in patients given the RD was 28 and 8%, respectively. All toxic effects were manageable. The response rate was 54.1%, and the median survival time was 15.5 months. Our phase I/II trial showed that S-1 combined with paclitaxel is effective and well tolerated in patients with advanced gastric cancer.

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A randomized Phase II trial in patients with carcinoma of an unknown primary site

Dowell¹,

Garrett²,

Shyr

et al. 2001

Cancer

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BACKGROUND Current therapy for patients with carcinoma of an unknown primary site (CUP) is inadequate. To develop less toxic and more effective therapies for patients with CUP, a multicenter, randomized, Phase II study was conducted. Patients with CUP received either carboplatin and etoposide (CE) or a combination of paclitaxel, 5‐fluorouracil, and leucovorin (TFL). METHODS Patients randomized to Arm A received paclitaxel, 175 mg/m2, intravenously over 3 hours on Day 1 followed by leucovorin, 300 mg, over 30–60 minutes and 5‐fluorouracil, 350 mg/m2, both intravenously on Days 1–3. Patients randomized to Arm B received etoposide, 100 mg/m2, intravenously on Days 1–3 and carboplatin at an area under the curve of 6 on Day 1 only. The cycles in both treatment arms were repeated every 28 days. Patients were followed for tumor response, survival, and toxicity. RESULTS Thirty‐four patients were enrolled, 32 of whom were evaluable for response. An identical overall response rate of 19% (95% confidence interval, 4–45%) was noted in each treatment arm. The median survival for the entire study population was 194 days. The median survivals observed in Arm A and Arm B were 251 days and 194 days, respectively (P = 0.91 [difference not significant]). Hematologic toxicity on Arm B was considerable with 29% of the patients developing neutropenia and fever. Toxicity on Arm A was modest. CONCLUSIONS In this randomized Phase II trial, CE and TFL appeared to have modest activity in CUP patients, with response rates similar to those reported with previously described chemotherapy regimens. Toxicity with CE was more severe than expected, although TFL was found to be well tolerated. Cancer 2001;91:592–7. © 2001 American Cancer Society.

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A phase II trial of paclitaxel and weekly 24 h infusion of 5-fluorouracil/folinic acid in patients with advanced gastric cancer

Cited by 52 publications

References 0 publications

A phase II study of paclitaxel, weekly, 24-hour continuous infusion 5-fluorouracil, folinic acid and cisplatin in patients with advanced gastric cancer

A phase II study of paclitaxel, weekly, 24-hour continuous infusion 5-fluorouracil, folinic acid and cisplatin in patients with advanced gastric cancer

Phase I/II study of S-1 combined with paclitaxel in patients with unresectable and/or recurrent advanced gastric cancer

A randomized Phase II trial in patients with carcinoma of an unknown primary site

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