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XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer

NCT ID: NCT00212615

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2008-10-31

Brief Summary

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XELOX (Capecitabine and Oxaliplatin) is an effective and convenient regimen for patients with metastatic colorectal cancer. Chronomodulated therapy may reduce toxicity. Patients will be randomized to standard XELOX (Capecitabine 1000 mg/m² in the morning and 1000 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes) or chronomodulated XELOX (Capecitabine 400 mg/m² in the morning and 1600 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes).

Bloodsamples will be collected and frozen and later examined for potential predictive factors

Detailed Description

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Conditions

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C04.588.274.476.411.307

Keywords

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Colorectal neoplasm Capecitabine (Xeloda) Oxaliplatin (Eloxatin) Advanced disease Metastatic disease First-line treatment Phase II study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Standard XELOX

Group Type ACTIVE_COMPARATOR

Oxaliplatin (Eloxatin)

Intervention Type DRUG

Capecitabine (Xeloda)

Intervention Type DRUG

B

Chronomodulated XELOX

Group Type ACTIVE_COMPARATOR

Oxaliplatin (Eloxatin)

Intervention Type DRUG

Capecitabine (Xeloda)

Intervention Type DRUG

Interventions

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Oxaliplatin (Eloxatin)

Intervention Type DRUG

Capecitabine (Xeloda)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histological proven adenocarcinoma of the colon or rectum
* Measurable or non-measurable disease
* Performance status 0-2
* Adequate renal and hepatic functions
* Adjuvant chemotherapy must have ended 180 days before inclusion
* Written informed consent prior to randomization

Exclusion Criteria

* Prior treatment with Eloxatin or Xeloda
* Peripheral neuropathy
* Evidence of CNS metastasis
* Other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months)
* Past history of malignant neoplasm within the past five years, except curatively treated non melanoma skin cancer
* Administration of any other experimental drug under investigation within 2 weeks before randomisation
* Pregnant or breast feeding women
* Fertile patients must use adequate contraceptives
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Per Pfeiffer

Professor, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Per Pfeiffer, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, Odense University Hospital

Locations

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Department of Oncology, Esbjerg Hospital

Esbjerg, , Denmark

Site Status

Department of Oncology, Herlev University Hospital

Herlev, , Denmark

Site Status

Department of Oncology, Herning Hospital

Herning, , Denmark

Site Status

Department of Oncology, Hillerød Hospital

Hillerød, , Denmark

Site Status

Department of Oncology, Næstved Hospital

Næstved, , Denmark

Site Status

Department of Oncology, Roskilde Hospital

Roskilde, , Denmark

Site Status

Department of Oncology, Radiumhemmet

Stockholm, , Sweden

Site Status

Department of Oncology, Uppsala University Hospital

Uppsala, , Sweden

Site Status

Countries

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Denmark Sweden

References

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Pfeiffer P, Hahn P, Jensen HA. Short-time infusion of oxaliplatin (Eloxatin) in combination with capecitabine (Xeloda) in patients with advanced colorectal cancer. Acta Oncol. 2003;42(8):832-6. doi: 10.1080/02841860310015894.

Reference Type BACKGROUND
PMID: 14968944 (View on PubMed)

Boisen MK, Johansen JS, Dehlendorff C, Larsen JS, Osterlind K, Hansen J, Nielsen SE, Pfeiffer P, Tarpgaard LS, Hollander NH, Keldsen N, Hansen TF, Jensen BB, Jensen BV. Primary tumor location and bevacizumab effectiveness in patients with metastatic colorectal cancer. Ann Oncol. 2013 Oct;24(10):2554-2559. doi: 10.1093/annonc/mdt253. Epub 2013 Jul 17.

Reference Type DERIVED
PMID: 23864097 (View on PubMed)

Other Identifiers

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KFE 03.17

Identifier Type: -

Identifier Source: secondary_id

XELOX III

Identifier Type: -

Identifier Source: org_study_id