Efficacy/Safety Study of Bevacizumab,Capecitabine,Oxaliplatin to Metastatic Colorectal Adenocarcinoma Elderly Patients.

• Status: Unknown status
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether bevacizumab, capecitabine and oxaliplatin are an effective and safe first line of treatment for elderly patients with metastatic colorectal adenocarcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo Espanol Multidisciplinario del Cancer Digestivo
• Treatments: Bevacizumab; Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• Written informed consent.

• ECOG 0-1.

• Age ≥ 70 years.

• Histologically confirmed carcinoma of the colon and/or rectum.

• Metastatic disease non suitable for radical surgery.

• At least one measurable metastatic lesion (as per RECIST criteria). The index lesion must not be in a previously irradiated area.

• Non prior chemotherapy for metastatic disease. Adjuvant (or neo-adjuvant for rectal cancer patients) chemotherapy allowed if completed ≥ 12 months before inclusion.

• Life expectancy more than 3 months.

• Adequate renal function: creatinine ≤ 1.5 x UL and calculated creatinine clearance ≥ 30 mL/min.

• Adequate level function: AST and ALT ≤ 2.5 x UL (≤ 5 x UL if liver metastases), bilirubin ≤ 1.5 x UL.

• Adequate haematological function: Hb ≥ 9 gr/dl, neutrophils ≥ 1,5 x 109 /l and platelets ≥ 100000 x 109/l.

• Urine dipstick for proteinuria < 2+. If urine dipstick is ≥ 2+, 24 hour urine must demonstrate ≤ 1 g of protein in 24 hours.

• No clinical evidence or history of metastatic CNS disease.

• No prior Bevacizumab treatment.

Exclusion Criteria:

• Patients who previously received bevacizumab.

• Prior chemotherapeutic treatment for metastatic CRC.

• Prior treatment with monoclonal antibodies.

• Clinical evidence of brain metastases or history or evidence upon physical examination of CNS disease unless adequately treated.

• Past or current history (within the last 5 years prior to treatment start) of other malignancies except metastatic colorectal cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible).

• Clinically significant cardiovascular disease, for example CVA (≤ 6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, NYHA ≥ grade 2, CHF, arrhythmia requiring medication, or uncontrolled hypertension.

• Intestinal occlusion/subocclusion.

• Chronic diarrhea.

• Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study.

• Known hypersensitivity to any of the study drugs.

• Current or recent (within 10 days of first dose of study treatment) daily use of aspirin (> 325 mg/day) or other NSAID.

• Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes. Patients receiving (or considered candidate to receive) anticoagulants agents as prophylaxis of cardiovascular risk, should continue (or start) the appropriate treatment at study entry.

• History of venous thromboembolic or haemorrhagic events within 6 months prior to treatment.

• Patients with previous of arterial thromboembolic event.

• Evidence of bleeding diathesis or coagulopathy.

• Serious, non healing wound, ulcer, or bone fracture.

• Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment, or anticipation of the need for major surgery during the course of the study.

• Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.

• Patients of childbearing potential not willing to use effective means of contraception.

• Positive HIV serology.

• Known addiction to alcohol or other drugs.

• Patients included in other clinical trial