Phase I study with a weekly 1 h infusion of paclitaxel in heavily pretreated patients with metastatic breast and ovarian cancer

Klaassen, U.; Wilke, H.; Strumberg, Dirk; Eberhardt, W; Korn, Michael; Seeber, S.

doi:10.1016/0959-8049(95)00641-9

Cited by 65 publications

(21 citation statements)

References 3 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Therefore, the efficacy of shorter infusion schedules of paclitaxel (TXL) has been investigated, and some phase I/II studies have reported that 1-h infusion of TXL at doses of 60 to 90 mg/m 2 weekly yielded low toxicity profiles. [14][15][16][17][18][19] The decreased leukocyte toxicity associated with short infusion times allows for reduced intertreatment periods, from the standard 3-week to a 1-week interval. Moreover, the response rate with weekly TXL administration appears to be comparable to that of the 3-week schedule.…”

Section: Introductionmentioning

confidence: 99%

Weekly 1-h paclitaxel infusion in patients with recurrent endometrial cancer: a preliminary study

Nishio

Ota

Sugiyama

et al. 2003

International Journal of Clinical Oncology

View full text Add to dashboard Cite

show abstract

Section: Introductionmentioning

confidence: 99%

Weekly 1-h paclitaxel infusion in patients with recurrent endometrial cancer: a preliminary study

Nishio

Ota

Sugiyama

et al. 2003

International Journal of Clinical Oncology

View full text Add to dashboard Cite

show abstract

“…In a phase II trial of PTX administration by 3-h infusion every 3 weeks for patients with gastric cancer, a 23% response rate was observed [8]. Weekly administration of PTX has been demonstrated to be well-tolerated and feasible in patients with ovarian cancer [10], breast cancer [11], and lung cancer [12]. Furthermore, PTX exerts its cytotoxic effects through a mechanism different from that of cisplatin and 5-FU, and shows no cross-resistance with cisplatin [13][14][15].…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetic study of weekly administration dose of paclitaxel in patients with advanced or recurrent gastric cancer in Japan

et al. 2007

View full text Add to dashboard Cite

Background. We aimed to clarify the relationship between the maximum tolerated dose and plasma concentration of paclitaxel in Japanese patients with gastric cancer on a weekly paclitaxel administration regimen. Methods. Thirty-three patients with advanced or recurrent gastric cancer were treated with escalating doses of paclitaxel, administered weekly, along with a fi xed dose of 5-fl uorouracil or cisplatin. Results. The plasma concentration of paclitaxel remained above 8.5 ng/ml for 24 h after administration. The mean area under the curve increased signifi cantly with escalating dosage levels (R = 0.63; P < 0.001). At level 4, patients showing doselimiting toxicity had a signifi cantly higher plasma paclitaxel concentration than patients without it. Conclusion. The weekly administration of paclitaxel, for which a single dose is about one-third of the dose for a triweekly treatment regimen, is clinically feasible and appropriate in terms of toxicity and the maintenance of an effective plasma concentration.

show abstract

“…Considering the cellular mode of action of paclitaxel, which is predominantly cytotoxic for dividing cells, repeated doses should show added benefits. Weekly administration of paclitaxel has been demonstrated to be well tolerated and feasible in patients with ovarian (9) and breast cancers (10).…”

Section: Introductionmentioning

confidence: 99%

Phase I Evaluation of Continuous 5-Fluorouracil Infusion Followed by Weekly Paclitaxel in Patients with Advanced or Recurrent Gastric Cancer

Kondo

Kobayashi²,

Kojima³

et al. 2005

Japanese Journal of Clinical Oncology

View full text Add to dashboard Cite

Objective: We conducted a phase I trial of escalating doses of weekly paclitaxel (Taxol) in combination with a fixed systemic administration of 5-fluorouracil (5-FU) in patients with advanced or metastatic gastric cancer. Methods: Patients with advanced or recurrent gastric cancer were treated with escalating doses of weekly paclitaxel as a 60 min intravenous (i.v.) infusion, along with a fixed dose of continuous 5-FU infused over 5 days. Plasma sampling was performed to characterize the pharmacokinetics and pharmacodynamics of paclitaxel. Results: Eighteen patients received combination therapy at four dose levels of weekly Taxol, ranging from 60 to 90 mg/m 2 /week. Dose-limiting toxicities >grade 3 were observed at the 90 mg/m 2 /week dose level. Toxicities included anemia, neutropenia, thrombocytopenia, nausea and alopecia. Two episodes of grade 4 neutropenia occurred in two of the three patients receiving this dose. At each dose level, pharmacological studies documented the persistence of significant serum paclitaxel levels over 24 h after drug administration. The maximum tolerated dose (MTD) for this regimen was 90 mg/m 2 /week of paclitaxel for 3 weeks plus 600 mg/m 2 /day of continuous 5-FU for 5 days. Conclusions: The combination of weekly paclitaxel and 5-FU demonstrated an acceptable toxicity profile and feasible pharmacokinetic results suggesting its practical applicability. Based on these findings, the recommended dose and schedule for phase II study of combination chemotherapy is paclitaxel 80 mg/m 2 /week · 3 over 4 weeks, and continuous 5-FU 600 mg/m 2 /day · 5 days every 4 weeks.

show abstract

Phase I study with a weekly 1 h infusion of paclitaxel in heavily pretreated patients with metastatic breast and ovarian cancer

Cited by 65 publications

References 3 publications

Weekly 1-h paclitaxel infusion in patients with recurrent endometrial cancer: a preliminary study

Weekly 1-h paclitaxel infusion in patients with recurrent endometrial cancer: a preliminary study

Pharmacokinetic study of weekly administration dose of paclitaxel in patients with advanced or recurrent gastric cancer in Japan

Phase I Evaluation of Continuous 5-Fluorouracil Infusion Followed by Weekly Paclitaxel in Patients with Advanced or Recurrent Gastric Cancer

Contact Info

Product

Resources

About