Oxaliplatin combined with irinotecan and 5-fluorouracil/leucovorin (OCFL) in metastatic colorectal cancer: a phase I-II study
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State: Public
Version: Final published version
License: Not specified
It was possible to publish this article open access thanks to a Swiss National Licence with the publisher.
State: Public
Version: Final published version
License: Not specified
It was possible to publish this article open access thanks to a Swiss National Licence with the publisher.
Serval ID
serval:BIB_2C2ACD8CD0E9
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Oxaliplatin combined with irinotecan and 5-fluorouracil/leucovorin (OCFL) in metastatic colorectal cancer: a phase I-II study
Journal
Annals of Oncology
ISSN
0923-7534 (Print)
Publication state
Published
Issued date
05/2005
Volume
16
Number
5
Pages
762-6
Notes
Clinical Trial
Clinical Trial, Phase I
Clinical Trial, Phase II
Journal Article
Multicenter Study --- Old month value: May
Clinical Trial, Phase I
Clinical Trial, Phase II
Journal Article
Multicenter Study --- Old month value: May
Abstract
BACKGROUND: A phase I-II multicenter trial was conducted to define the maximal tolerated dose and describe the activity of an OCFL combination using oxaliplatin (OHP), irinotecan (CPT-11) and 5-fluorouracil (FU)/leucovorin (LV) in metastatic colorectal cancer (CRC). PATIENTS AND METHODS: CRC patients not pretreated with palliative chemotherapy, with performance status < or =1 and adequate haematological, kidney and liver function, were eligible. Treatment consisted in weekly 24-h infusion 5-FU (2300 mg/m(2))/LV (30 mg) and alternating OHP (70-85 mg/m(2), days 1 and 15) and CPT-11 (80-140 mg/m(2), days 8 and 22) repeated every 5 weeks. OHP and CPT-11 were escalated in cohorts of three to six patients. RESULTS: Thirty patients received a median of five cycles. Dose-limiting toxicity occurred at dose level 3, and the recommended dose was OHP 70 mg/m(2), CPT-11 100 mg/m(2), LV 30 mg and 5-FU 2300 mg/m(2)/24 h. Grade > or =3 toxicities were diarrhea 23%, neutropenia 20%, fatigue 7%, and neurologic 7%. Two febrile neutropenia episodes (one fatal) were recorded. Among 28 patients with measurable disease (90%), we observed two complete and 20 partial responses; overall RR was 78% (95% CI, 59% to 92%). Median time to progression and overall survival were 9.5 and 25.4 months, respectively. Seven patients underwent liver metastases resection. CONCLUSION: OCFL is an overall well tolerated regimen with very high efficacy, which makes it most suitable for tumour control before surgery of metastatic disease.
Keywords
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols/adverse
effects/*therapeutic use
Camptothecin/adverse effects/analogs & derivatives/therapeutic use
Colorectal Neoplasms/*drug therapy/*mortality/pathology
Dose-Response Relationship, Drug
Drug Administration Schedule
Female
Fluorouracil/adverse effects/therapeutic use
Humans
Leucovorin/adverse effects/therapeutic use
Liver Neoplasms/drug therapy/*secondary
Lung Neoplasms/drug therapy/*secondary
Male
Maximum Tolerated Dose
Middle Aged
Neoplasm Metastasis
Neoplasm Staging
Organoplatinum Compounds/adverse effects/therapeutic use
*Palliative Care
Prognosis
Survival Analysis
Treatment Outcome
Pubmed
Web of science
Open Access
Yes
Create date
28/01/2008 8:39
Last modification date
14/02/2022 7:54