A Randomised, Double-blind, Multicentre Phase II/III Study to Compare the Efficacy of AZD2171 in Combination with 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX), to the Efficacy of Bevacizumab in Combination with FOLFOX in Patients with Previously Untreated Metastatic Colorectal Cancer - D8480C00013
- Conditions
- MedDRA version: 14.1Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]Patients with Previously Untreated Metastatic Colorectal Cancer
- Registration Number
- EUCTR2005-003440-66-IT
- Lead Sponsor
- ASTRAZENECA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1805
1. Provision of written informed consent. 2. Males or females aged 18 years and older. 3. Histological or cytological confirmation of carcinoma of the colon or rectum. 4. Stage IV (metastatic) disease with one or more measurable lesions at least 10 mm in the longest diameter by spiral computed tomography scan or 20 mm with conventional techniques (RECIST criteria). 5. Patients must have received no prior systemic therapy for metastatic disease, except adjuvant therapy >12 months prior to study entry. 6. World Health Organisation (WHO) Performance score inferior to 2. 7. Life expectancy of major or equal to 12 weeks. Genetic research For inclusion in the genetic research component of the study, patients must fulfil the following criterion: 1. Provision of informed consent for genetic research. If a patient declines to participate in the genetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Any of the following is regarded as a criterion for exclusion from the study:
1.Adjuvant therapy within 12 months of study entry.
2.Any unresolved toxicity >CTC grade 2 from previous treatments.
3.Prior therapy with monoclonal antibodies or small molecule inhibitors against VEGF or VEGF receptors, including bevacizumab and AZD2171.
4.Prior therapy with oxaliplatin within 12 months of study entry.
5.Untreated brain or meningeal metastases. Patients with treated and radiological or clinical evidence of stable brain metastases are eligible if asymptomatic and corticosteroids are not required (patients must have discontinued steroids at least 4 weeks prior to registration).
6.Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count ≤1.5 x 109/L or platelet count ≤100 x 109/L or requiring regular blood transfusions to maintain haemoglobin >9 g/dL.
7.Serum bilirubin ≥1.5 x upper limit of reference range (ULRR).
8.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.5 x ULRR. If liver metastases are present, ALT or AST ≥5 x ULRR.
9.Serum creatinine ≥1.5 x ULRR or a creatinine clearance of ≤50 mL/min calculated by Cockroft-Gault formula (see Section 4.7.2.2).
10.Greater than +1 proteinuria on 2 consecutive dipsticks taken no less than 1 week apart unless urinary protein, <1.5 g in a 24 hour urine collection.
11.Patients with a history of poorly controlled hypertension with resting BP >150/100 mmHg in the presence or absence of a stable regimen of anti hypertensive therapy. Measurements will be made after the patient has been resting supine for a minimum of 5 minutes. Two or more readings should be taken at 2 minute intervals and averaged. If the first 2 diastolic readings differ by more than 5mmHg, then an additional reading should be obtained, and averaged.
Please see Protocol for other criteria
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method