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

Sponsor

Odense University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00212615

Collaborator

(none)

116

Enrollment

Locations

Arms

Actual Duration (Months)

14.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
C04.588.274.476.411.307	Drug: Oxaliplatin (Eloxatin) Drug: Capecitabine (Xeloda)	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 1, 2004

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A Standard XELOX	Drug: Oxaliplatin (Eloxatin) Drug: Capecitabine (Xeloda)
Active Comparator: B Chronomodulated XELOX	Drug: Oxaliplatin (Eloxatin) Drug: Capecitabine (Xeloda)

Arm

Intervention/Treatment

Active Comparator: A

Standard XELOX

Drug: Oxaliplatin (Eloxatin)

Drug: Capecitabine (Xeloda)

Active Comparator: B

Chronomodulated XELOX

Drug: Oxaliplatin (Eloxatin)

Drug: Capecitabine (Xeloda)

Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Department of Oncology, Esbjerg Hospital	Esbjerg	Denmark	6700
2	Department of Oncology, Herlev University Hospital	Herlev	Denmark	2730
3	Department of Oncology, Herning Hospital	Herning	Denmark	7400
4	Department of Oncology, Hillerød Hospital	Hillerød	Denmark	3400
5	Department of Oncology, Næstved Hospital	Næstved	Denmark	4700
6	Department of Oncology, Roskilde Hospital	Roskilde	Denmark	4000
7	Department of Oncology, Radiumhemmet	Stockholm	Sweden	100 26
8	Department of Oncology, Uppsala University Hospital	Uppsala	Sweden	751 85