Status:
COMPLETED
Xeloda and Bevacizumab to Treat Rectal Cancer
Lead Sponsor:
Institut Català d'Oncologia
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The project objective is to evaluate the efficacy of the neoadjuvant treatment with bevacizumab, capecitabine and radiotherapy, in patients with rectal adenocarcinoma resectable locally advanced (stag...
Eligibility Criteria
Inclusion
- The patient has given written informed consent prior to any study related procedure
- Male and female aged 18 to 75 years
- ECOG performance status 0 or 1
- Histologically confirmed diagnostic of adenocarcinoma of the rectum \< 15 cm from anal verge
- Clinical stage of T3, T4 with/without regional lymph node metastases, without metastatic disease
- Disease evaluable by imaging techniques
- No tumour haemorrhage in the week prior to start of study treatment
- External derivation in symptomatic occlusive tumours
- Not prior cancer treatment
- Adequate bone marrow, hepatic and renal function, defined as:
- White blood cells ≥ 4 x 109 /l
- Absolute neutrophil count ≥ 1.5 x 109 /l
- Platelets ≥ 100 x 109 /l
- Haemoglobin ≥10 g/dl
- Bilirubin \< 1.25 x upper limit of normal
- Aspartate transaminase and alanine transaminase \< 2.5 x upper limit of normal
- Serum creatinine ≤ 106 µmol/l
- Less than 10% weight loss
Exclusion
- Rectal cancer no amenable to resection
- Any other malignancy which has been active or treated within the past 5 years , with the exception of in situ carcinoma of the cervix and non-melanoma skin lesions adequately treated
- Pregnant or breast-feeding women
- Women oh childbearing potential unless effective methods of contraception are used
- No prior or concurrent significant medical conditions, including any of the following:
- Cerebrovascular disease (including transient ischemic attack and stroke) within the past year
- Cardiovascular disease, including the following:
- Myocardial infarction within the past year
- Uncontrolled hypertension while receiving chronic medication
- Unstable angina
- New York Heart Association class II-IV congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Major trauma within the past 28 days
- Serious nonhealing wound, ulcer, or bone fracture
- Evidence of bleeding diathesis or coagulopathy
- No lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication
- No evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug
- No known dihydropyrimidine dehydrogenase deficiency
- Major surgery in the 4 weeks prior to the start of study treatment
- No concurrent chronic, daily treatment with aspirin (\> 325 mg/day)
- More than 10 days since prior use of full-dose oral or parenteral anticoagulants for therapeutic purposes
- No participation in another clinical trial with any investigational drug within 30 days prior to randomization or during study participation
- No other medical history or condition that, in the opinion of the investigator, would preclude study participation
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00847119
Start Date
September 1 2007
End Date
February 1 2015
Last Update
August 29 2017
Active Locations (1)
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1
Institut Català d'Oncologia-L'Hospitalet
L'Hospitalet Del Llobregat, Barcelona, Spain, 08907