Oxaliplatin combined with irinotecan and 5-fluorouracil/leucovorin (OCFL) in metastatic colorectal cancer: a phase I-II study

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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
Author(s)
Seium  Y., Stupp  R., Ruhstaller  T., Gervaz  P., Mentha  G., Philippe  M., Allal  A., Trembleau  C., Bauer  J., Morant  R., Roth  A. D.
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
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
25/09/2019 6:08
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