Randomized Phase II Trial Testing the Efficacy of Three Bevacizumab-Containing First-Line Regimens for Metastatic Colorectal Cancer.

Phase 1

• Conditions: First-line chemotherapy for patients with metastatic colorectal cancer; 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]

• Registration Number: EUCTR2005-000285-39-IT
• Lead Sponsor: ROCHE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-11
• Study Completion: 2012-11-02
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Histologically or cytologically proven diagnosis of colon or rectum with metastatic disease. 2. Patients must not have previously received systemic treatment for advanced disease. Adjuvant chemotherapy or neo-adjuvant treatment for non-metastatic disease (M0) is allowed if completed at least 6 months prior to initiation of the study treatment. If prior adjuvant therapy was received, patients must not have progressed during therapy or within 6 months of its completation. 3. Age >= 18 4. ECOG Performance Status 0-1 (Appendix I) 5. Life expectancy of at least 12 weeks 6. At least one target lesion with a minimum lesion size as per the RECIST criteria 7. Laboratory requirements: - Neutrophils >=1.5 x 109/L, Platelets >= 100 x 109/L, and Haemoglobin >= 10g/dL - Total bilirubin <= 1.5 time the upper-normal limits (UNL) of the Institutional normal values; 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; LDH <1500 U/L - 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 <= 1g 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: 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

Exclusion Criteria

1. Radiotherapy to any site within 4 weeks before the study. 2. Symptomatic and/or unstable pre-existing brain metastases or leptomeningeal metastases requiring medication. 3. History of inflammatory bowel disease and/or acute/subacute bowel occlusion. 4. Serious non-healing wound or ulcer. 5. Evidence of bleeding diathesis or coagulopathy. 6. Uncontrolled hypertension. 7. 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. 8. Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants for therapeutic purposes. 9. Chronic, daily treatment with high-dose aspirin (>325 mg/day) or other medications known to predispose to gastrointestinal ulceration. 10. Treatment with any investigational drug within 30 days prior to enrolment. 11. Patients with known allergy to Chinese hamster ovary cell proteins, or any of the components of the study medications 12. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ 13. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study. 14. Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication. 15. Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified