Status:
UNKNOWN
Combination Chemotherapy With or Without Cetuximab as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Velindre NHS Trust
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ch...
Detailed Description
OBJECTIVES: Primary * Compare the overall survival of patients with metastatic colorectal adenocarcinoma treated with continuous combination chemotherapy comprising oxaliplatin, leucovorin calcium, ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of colorectal adenocarcinoma, defined by 1 of the following:
- Histologically confirmed primary adenocarcinoma of the colon or rectum with clinical or radiological evidence of advanced and/or metastatic disease
- Histologically or cytologically confirmed metastatic adenocarcinoma with clinical or radiological evidence of primary colorectal tumor
- Unidimensionally measurable disease
- Inoperable metastatic or locoregional disease
- Ineligible for hepatic resection after first-line combination chemotherapy
- 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)
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
2421 Patients enrolled
Trial Details
Trial ID
NCT00182715
Start Date
March 1 2005
Last Update
September 17 2013
Active Locations (82)
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1
Mercy University Hospital
Cork, Ireland
2
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, Ireland, 24
3
St. Vincent's University Hospital
Dublin, Ireland, 4
4
Mater Misericordiae University Hospital
Dublin, Ireland, 7