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

Primary Purpose

C04.588.274.476.411.307

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Oxaliplatin (Eloxatin)
Capecitabine (Xeloda)
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for C04.588.274.476.411.307 focused on measuring Colorectal neoplasm, Capecitabine (Xeloda), Oxaliplatin (Eloxatin), Advanced disease, Metastatic disease, First-line treatment, Phase II study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Oncology, Esbjerg Hospital
  • Department of Oncology, Herlev University Hospital
  • Department of Oncology, Herning Hospital
  • Department of Oncology, Hillerød Hospital
  • Department of Oncology, Næstved Hospital
  • Department of Oncology, Roskilde Hospital
  • Department of Oncology, Radiumhemmet
  • Department of Oncology, Uppsala University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

Standard XELOX

Chronomodulated XELOX

Outcomes

Primary Outcome Measures

Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event)

Secondary Outcome Measures

Physical examination: before treatment (each 3 weeks)
Performance status: before treatment (each 3 weeks)
Haematology: before treatment (each 3 weeks)
Tumor biology: after 1st treatment, every 9th weeks herafter
Biochemistry: after every 3rd treatment (each 9th weeks)
Tumor assesment: after every 3rd treatment (each 9th weeks)

Full Information

First Posted
September 13, 2005
Last Updated
November 4, 2020
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00212615
Brief Title
XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer
Official Title
XELOX III. Capecitabine (Xeloda) in Combination With Oxaliplatin (Eloxatin) as First-line Treatment of Patients With Advanced or Metastatic Colorectal Cancer. A Randomized Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 2004 (Actual)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
C04.588.274.476.411.307
Keywords
Colorectal neoplasm, Capecitabine (Xeloda), Oxaliplatin (Eloxatin), Advanced disease, Metastatic disease, First-line treatment, Phase II study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Standard XELOX
Arm Title
B
Arm Type
Active Comparator
Arm Description
Chronomodulated XELOX
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin (Eloxatin)
Intervention Type
Drug
Intervention Name(s)
Capecitabine (Xeloda)
Primary Outcome Measure Information:
Title
Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event)
Secondary Outcome Measure Information:
Title
Physical examination: before treatment (each 3 weeks)
Title
Performance status: before treatment (each 3 weeks)
Title
Haematology: before treatment (each 3 weeks)
Title
Tumor biology: after 1st treatment, every 9th weeks herafter
Title
Biochemistry: after every 3rd treatment (each 9th weeks)
Title
Tumor assesment: after every 3rd treatment (each 9th weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Pfeiffer, MD
Organizational Affiliation
Department of Oncology, Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, Esbjerg Hospital
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Department of Oncology, Herlev University Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Department of Oncology, Herning Hospital
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Department of Oncology, Hillerød Hospital
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Department of Oncology, Næstved Hospital
City
Næstved
ZIP/Postal Code
4700
Country
Denmark
Facility Name
Department of Oncology, Roskilde Hospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Department of Oncology, Radiumhemmet
City
Stockholm
ZIP/Postal Code
100 26
Country
Sweden
Facility Name
Department of Oncology, Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
14968944
Citation
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.
Results Reference
background
PubMed Identifier
23864097
Citation
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.
Results Reference
derived

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

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