Optimization of Bevacizumab Scheduling With Chemotherapy for Metastatic Colorectal Cancer

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate if giving bevacizumab prior to chemotherapy compared to giving bevacizumab at the same time as chemotherapy improves patient overall response to treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Bevacizumab; Capecitabine; Fluorouracil; Folic Acid; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• Histological diagnosis of colorectal adenoma carcinoma

• Stage IV disease

• Presence of at least one measurable target lesion (according to RECIST), and not previously radiated.

• Age ≥ 18 e ≤ 75 years

• ECOG Performance status 0-1

• Life expectancy >3 months

• Adequate recovery from surgery, with at least 28 days from surgery to date of pre-study biopsy.

• Adequate contraception for male and female patients of child bearing potential

• informed consent

Exclusion Criteria:

• More than one previous line of therapy for metastatic disease

• Prior treatment with bevacizumab or oxaliplatin (previous treatment with irinotecan,, cetuximab, fluoropyrimidine, folic acid are permitted)

• Primary tumor that is stenosing and/or that infiltrates the entire thickness of the intestinal wall

• Regular use of NSAIDs or aspirin

• Bleeding disorders or coagulopathy

• Concurrent anticoagulant therapy

• Suspected or cerebral metastases (to verify in the presence of symptoms)

• Neutrophils < 2000 / mm3, platelets < 100,000 / mm3, hemoglobin < 9g/dl

• Creatinine > 1.5 times the upper normal limit

• GOT and/or GPT > 2.5 times the upper normal limit, bilirubin > 1.5 times the upper normal limit in absence of liver metastases

• GOT and/or GPT > 5 times the upper normal limit, bilirubin > 3 times the upper normal limit in presence of liver metastases

• Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal and squamous cell carcinoma or cervical cancer in situ

• Congestive heart failure, ischemic coronary events within past 12 months, uncontrolled cardiac arrhythmia

• Uncontrolled hypertension

• Active or uncontrolled infection

• Any concomitant condition that, in the investigator's opinion, would contraindicate the use of any of the study drugs

• Pregnancy or lactation

• Central nervous system disorders or peripheral neuropathy > grade 1 (CTCAE v. 4.0)

• Inability to comply with follow up procedures of the study