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

NCT00212615 | Completed Phase 2

• 2 other identifiers: XELOX IIIKFE 03.17
• Study Type: interventional
• Target: 116
• Locations: 2 countries
• Sites: 8

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

Conditions

C04.588.274.476.411.307

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

• 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)

Study Arms (2)

A

ACTIVE COMPARATOR

Standard XELOX

Drug: Oxaliplatin (Eloxatin); Drug: Capecitabine (Xeloda)

B

ACTIVE COMPARATOR

Chronomodulated XELOX

Drug: Oxaliplatin (Eloxatin); Drug: Capecitabine (Xeloda)

Interventions

Oxaliplatin (Eloxatin) DRUG

A; B

Capecitabine (Xeloda) DRUG

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological proven adenocarcinoma of the colon or rectum
• Measurable or non-measurable disease
• Performance status 0-2
• Adequate renal and hepatic functions
• Written informed consent prior to randomization

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (8)

Department of Oncology, Esbjerg Hospital

Esbjerg, 6700, Denmark

Location

Department of Oncology, Herlev University Hospital

Herlev, 2730, Denmark

Location

Department of Oncology, Herning Hospital

Herning, 7400, Denmark

Location

Department of Oncology, Hillerød Hospital

Hillerød, 3400, Denmark

Location

Department of Oncology, Næstved Hospital

Næstved, 4700, Denmark

Location

Department of Oncology, Roskilde Hospital

Roskilde, 4000, Denmark

Location

Department of Oncology, Radiumhemmet

Stockholm, 100 26, Sweden

Location

Department of Oncology, Uppsala University Hospital

Uppsala, 751 85, Sweden

Location

Related Publications (2)

• 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.

  PMID: 14968944 BACKGROUND

• 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.

  PMID: 23864097 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Per Pfeiffer, MD

  Department of Oncology, Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, M.D.

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: February 1, 2004
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 6, 2020

Record last verified: 2020-11

Locations

DK (6); SE (2)