FRAIL PATIENTS WITH UNTREATED METASTATIC COLORECTAL CANCER MedDRA version: 9.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer
Conditions
Sponsors
ICORG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients > 18 years 2.Histologically or cytologically proven adenocarcinoma of the colon at first diagnosis 3.Stage IV disease, with at least one measurable lesion according to the RECIST criteria 4.ECOG performance status 2 or over the age of 70 and ECOG1 5.No prior chemotherapy for metastatic colorectal cancer 6.Prior adjuvant chemotherapy is permitted. 7.At least 28 days since prior surgery 8.If female of childbearing potential, pregnancy test is negative and willing to use effective contraception while on treatment and for at least 3 months thereafter. 9.Patient is accessible and willing to comply with treatment and follow-up 10.Patient is willing to provide written informed consent prior to the performance of any study-related procedures 11.Required laboratory values a.Absolute neutrophil count > 1.5 x 10 9/L b.Hemoglobin > 9.0 g/dL c.Platelet count > 100 x 10 9/L d.Creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Prior chemotherapy for metastatic colorectal cancer 2.Prior treatment with an anti-angiogenic agent 3.Concurrent therapy with any other non-protocol anti-cancer therapy 4.Current or prior history of central nervous system or brain metastases 5.Presence of neuropathy > grade 2 (NCI-CTC version 3.0) at baseline 6.Presence of any non-healing wound, fracture, or ulcer, or the presence of clinically significant (> grade 2) peripheral vascular disease 7.History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix 8.Clinically significant cardiovascular disease (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100mmHg on antihypertensive medications, myocardial infarction or stroke within the past 6 months, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication or any prior history of hypertensive crisis or hyertensive encephalopathy 9.Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning therapy 10.Active infection requiring parenteral antimicrobials 11.The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications 12.Inability to comply with the study protocol or follow-up procedures 13.Pregnancy or lactation 14.A history of a severe hypersensitivity reaction to bevacizumab, or capecitabine or 5Fu or other drugs formulated with polysorbate 80. 15.Evidence of bleeding diathesis or coagulopathy, history or presence of esophageal varices. 16.Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of the need for a major surgical procedure during the course of the study; minor surgical procedure, fine needle aspiration or core biopsy within 7 days prior to Day 0 17.Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study 18.Unstable angina 19.Urine protein creatinine ratio greater than or equal to 1. 20.Therapeutic anticoagulation with oral anticoagulation medications, specifically Coumarins 21. Known dihydropyrimidine dehydrogenase (DPD) deficiency. 22. Severe renal impairment (creatinine clearance below 30 mL/min [Cockroft and Gault]). 23. Life expectancy of less than 12 weeks. 24. Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To determine the anti-tumor activity of bevacizumab plus capecitabine based on time to disease progression •To evaluate the tolerability of bevacizumab plus capecitabine treatment in a patient population that is elderly or frail (poor performance) ;Secondary Objective: •To determine response rates and duration of response •To evaluate the effect of bevacizumab plus capecitabine treatment on the quality of life of patients •To evaluate cost-effectiveness •To measure the rate of the functional decline ;Primary end point(s): •Response Evlauation Criteria in Solid Tumors (RECIST) will be used to evaluate the anti-tumor activity and disease progression of bevacizumab plus capecitabine •National Cancer Institute Common Toxicity Criteria will be used to assess the tolerability, safety and toxicity of the treatments •Progression Free Survival (PFS) will be used to assess primary endpoint for bevacizumab trials | — |
Countries
Ireland
Outcome results
None listed