Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assessed the efficiency of treatment based on the objective response rate (RECIST 1.1)

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

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Treatments: Bevacizumab; Capecitabine; Irinotecan

Criteria

Inclusion Criteria:

• Liver metastases of colon cancer or rectal predominant (histological evidence obtained on the primary tumor or liver metastases)

• Isolated (no extra-hepatic metastasis, primary tumor resected)

• No access to curative hepatectomy (R0 resection foreseeable or not leaving less than 30% residual non-tumor liver normally vascularized), or requiring complex hepatectomy, very large (5 or more segments) and / or risked (class II CPP)

• which at least one measurable by RECIST (>2 cm, or >1 cm if Computed tomography (CT) spiraled)

• Or extra-hepatic disease of small size potentially accessible to a resection (one or two lung metastases, lymphadenopathy localized accessible to curative resection)

• colon or rectal primary tumor : resected or asymptomatic

• Progression after first line chemotherapy to treat the metastatic disease, all types of treatment allowed except intra-arterial Bevacizumab

• Age >18 years <75 years

• Performance status WHO 0 or 1

• Life expectancy >3 months

• Bilirubin <1.5 times the upper limit of normal (N), ASAT and ALAT <5N, creatinine <1.5 N neutrophils >1.5 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin >9g/dL. Patients may be included even if they were transfused

• CT (or MRI) reference for the measurement of metastases performed within 28 days before the first treatment cycle

• Information of the patient or legal representative signing the informed consent

• Affiliated to a social security system

Exclusion Criteria:

• Symptomatic colon or rectal primary tumor (sub-occlusion, significant hemorrhage, major rectal syndrome)

• Extra-hepatic metastases other than small size disease potentially accessible after resection

• Grade 3-4 allergy to one of the treatment compounds

• Two lines of prior chemotherapy. One line is allowed for metastatic disease but must have been started more than 6 months after completion of adjuvant treatment.

• Participation during or within 30 days before study to another therapeutic trial with an experimental molecule

• Concomitant cancer systemic treatment using immunotherapy, chemotherapy or hormone

• Symptomatic CHD or myocardial infarction within 6 months prior entry into the study, cardiac arrhythmia uncontrolled despite treatment

• Uncontrolled hypertension (blood pressure >150/100 mm Hg despite hypertensive treatment)

• Heart Failure >Grade II of the New York Heart Association (NYHA) (class II-III-IV)severe renal failure

• History and / or presence of bleeding disorders and/or thrombotic <6 months

• Uncontrolled Serious illness, uncontrolled active infection or other serious underlying condition which may prevent the patient to receive treatment

• Pregnancy (or positive pregnancy test at baseline), lactation or no contraception effective for men or women of childbearing age

• Occlusion or sub-bowel obstruction or history of inflammatory bowel disease

• Other cancer within 5 years prior to entry into the trial or concomitant (except in situ cancer of the cervix or skin basal-cell carcinoma properly treated)

• Legal inability (persons deprived of liberty or under guardianship)

• Inability to sign the consent or submit to medical test for geographical, social or psychological reasons.