Phase I-II Study of the Combination of Bevacizumab (rhuMAb VEGF) and Erlotinib (EGFR TKI) plus Oxaliplatin and Capecitabine (XELOX) in Patients with Metastatic Colorectal Cancer: XELOX-TARAV study - XELOX-TARAV

Conditions: Patients with metastatic colorectal cancer, who have not previously received systemic treatment for metastatic disease.
MedDRA version: 12.0Level: LLTClassification code 10055114Term: Colon cancer metastatic

Registration Number: EUCTR2005-005548-21-IT

Lead Sponsor: CONSORZIO ONCOTECH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Histologically or cytologically proven diagnosis of colorectal cancer 2. Metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease 3. Age >= 18 4. ECOG Performance Status 0-1 (Appendix III) 5. Life expectancy of at least 12 weeks 6. Measurable and/or evaluable lesions according to RECIST criteria 7. Laboratory requirements: Neutrophils >=1.5 x 10(9)/L and Platelets >=100 x 10(9)/L Total bilirubin <=1.5 time the upper-normal limits (UNL) of the Institutional normal values and ASAT (SGOT) and/or ALAT (SGPT) <=2.5 x UNL, or <=5 x UNL in case of liver metastases, alkaline phosphatase <=2.5 x UNL, <=5 x UNL in case of liver metastases, <=10 x UNL in case of bone metastases.  Creatinine clearance >50 mL/min or serum creatinine <=1.5 x UNL)  Urine dipstick of proteinuria <2+. Patients discovered to have >=2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate <=1 g of protein/24 hr. 8. Written informed consent. 9. Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating center
Are the trial subjects under 18? no
Number of subjects for this age range:
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

Exclusion Criteria

1. Radiotherapy to any site within 4 weeks before the study. 2. Prior adjuvant chemotherapy with an oxaliplatin-containing regimen. 3. Symptomatic and/or unstable pre-existing brain metastases. 4. History of inflammatory bowel disease and/or acute/subacute bowel occlusion. 5. Serious non-healing wound or ulcer. 6. Evidence of bleeding diathesis or coagulopathy. 7. Uncontrolled hypertension. 8. Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤6 months), myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication. 9. Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes. 10. Chronic, daily treatment with high-dose aspirin (>325 mg/day) or other medications known to predispose to gastrointestinal ulceration.