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NCT00182715

Combination Chemotherapy With or Without Cetuximab as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

Last Updated: 2013-09-17

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

2421 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy and cetuximab are more effective than combination chemotherapy alone in treating colorectal cancer.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and cetuximab to see how well they work compared to combination chemotherapy alone as first-line therapy in treating patients with metastatic colorectal cancer.

Detailed Description

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OBJECTIVES:

Primary

* Compare the overall survival of patients with metastatic colorectal adenocarcinoma treated with continuous combination chemotherapy comprising oxaliplatin, leucovorin calcium, and fluorouracil (OxMdG) or oxaliplatin and capecitabine (XELOX) with vs without cetuximab vs intermittent combination chemotherapy with OxMdG or XELOX as first-line therapy.

Secondary

* Compare time of disease control and progression- and failure-free survival of patients treated with these regimens.
* Compare response in patients treated with these regimens.
* Compare the toxicity of these regimens in these patients.
* Compare the cost effectiveness of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a multicenter, open label, randomized, controlled study. Patients are randomized to 1 of 3 treatment arms.

* Arm I (continuous chemotherapy): Patients receive 1 of the following combination chemotherapy regimens of their choice (or as per participating center):

* OxMdG: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1 and 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
* XELOX: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
* Arm II (continuous chemotherapy and cetuximab): Patients receive OxMdG or XELOX as in arm I. Patients also receive cetuximab IV over 1-2 hours on days 1 and 8 (for patients receiving OxMdG) OR days 1, 8, and 15 (for patients receiving XELOX). Treatment with OxMdG and cetuximab repeats every 14 days in the absence of disease progression or unacceptable toxicity. Treatment with XELOX and cetuximab repeats every 21 days in the absence of disease progression or unacceptable toxicity.
* Arm III (intermittent chemotherapy): Patients receive OxMdG or XELOX as in arm I. Treatment with OxMdG repeats every 14 days for up to 6 courses (12 weeks). Treatment with XELOX repeats every 21 days for up to 4 courses (12 weeks). Patients with disease progression after 12 weeks of therapy are removed from study treatment. Patients with stable or responding disease after 12 weeks of therapy stop treatment and undergo clinical evaluation at least every 6 weeks (treatment break) until disease progression or clinical deterioration. Upon evidence of disease progression or clinical deterioration, patients restart treatment with OxMdG or XELOX as before and continue to alternate 12 weeks of treatment with treatment breaks in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline, 6 weeks, 12 weeks, and then every 12 weeks thereafter.

After completion of study treatment, patients are followed every 12 weeks for survival.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 2,421 patients (807 per treatment arm) will be accrued for this study within 3.5 years.

Conditions

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Colorectal Cancer

Keywords

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adenocarcinoma of the colon stage IV colon cancer adenocarcinoma of the rectum stage IV rectal cancer

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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cetuximab

Intervention Type BIOLOGICAL

capecitabine

Intervention Type DRUG

fluorouracil

Intervention Type DRUG

leucovorin calcium

Intervention Type DRUG

oxaliplatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* No brain metastases

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* WHO 0-2

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* Bilirubin ≤ 1.25 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 5 times ULN
* AST or ALT ≤ 2.5 times ULN

Renal

* Creatinine clearance or glomerular filtration rate ≥ 50 mL/min

Cardiovascular

* No poorly controlled angina
* No myocardial infarction within the past 3 months

Other

* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* Must be considered fit to undergo combination chemotherapy
* No psychiatric or neurological condition that would preclude study compliance or giving informed consent
* No partial or complete bowel obstruction
* No other malignant disease that would preclude study treatment
* No preexisting neuropathy \> grade 1
* No known hypersensitivity reaction to any of the components of study drugs
* No known DPD deficiency or personal or family history suggestiv of DPD deficiency
* No other severe uncontrolled medical illness that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior systemic palliative chemotherapy for metastatic disease
* No prior oxaliplatin
* More than 1 month since prior adjuvant fluorouracil (5-FU) (with or without leucovorin calcium), capecitabine, or irinotecan
* More than 1 month since prior rectal chemoradiotherapy with 5-FU (with or without leucovorin calcium) or capecitabine

Endocrine therapy

* Not specified

Radiotherapy

* See Chemotherapy

Surgery

* Not specified

Other

* No concurrent brivudine or sorivudine (for patients receiving capecitabine on study)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

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Timothy Maughan, MD

Role: STUDY_CHAIR

Velindre NHS Trust

Locations

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Mercy University Hospital

Cork, , Ireland

Site Status

Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital

Dublin, , Ireland

Site Status

St. Vincent's University Hospital

Dublin, , Ireland

Site Status

Mater Misericordiae University Hospital

Dublin, , Ireland

Site Status

Mater Private Hospital

Dublin, , Ireland

Site Status

St. James's Hospital

Dublin, , Ireland

Site Status

Beaumont Hospital

Dublin, , Ireland

Site Status

Galway University Hospital

Galway, , Ireland

Site Status

Mid-Western Cancer Centre at Mid-Western Regional Hospital

Limerick, , Ireland

Site Status

Waterford Regional Hospital

Waterford, , Ireland

Site Status

North Hampshire Hospital

Basingstoke, England, United Kingdom

Site Status

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, United Kingdom

Site Status

Blackpool Victoria Hospital

Blackpool, England, United Kingdom

Site Status

Royal Bournemouth Hospital NHS Trust

Bournemouth, England, United Kingdom

Site Status

Bradford Royal Infirmary

Bradford, England, United Kingdom

Site Status

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, United Kingdom

Site Status

Bristol Haematology and Oncology Centre

Bristol, England, United Kingdom

Site Status

Queen's Hospital

Burton-on-Trent, England, United Kingdom

Site Status

West Suffolk Hospital

Bury St Edmunds, England, United Kingdom

Site Status

Addenbrooke's Hospital

Cambridge, England, United Kingdom

Site Status

Cumberland Infirmary

Carlisle, England, United Kingdom

Site Status

Cheltenham General Hospital

Cheltenham, England, United Kingdom

Site Status

Essex County Hospital

Colchester, England, United Kingdom

Site Status

Derbyshire Royal Infirmary

Derby, England, United Kingdom

Site Status

Dorset County Hospital

Dorchester, England, United Kingdom

Site Status

Eastbourne District General Hospital

Eastbourne, England, United Kingdom

Site Status

Princess Alexandra Hospital

Essex, England, United Kingdom

Site Status

St. Luke's Cancer Centre at Royal Surrey County Hospital

Guildford, England, United Kingdom

Site Status

Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, United Kingdom

Site Status

Princess Royal Hospital at Hull and East Yorkshire NHS Trust

Hull, England, United Kingdom

Site Status

Hinchingbrooke Hospital

Huntingdon, England, United Kingdom

Site Status

Cookridge Hospital

Leeds, England, United Kingdom

Site Status