Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy (BEVIAC)

Gustave Roussy

Status and phase

Completed

Phase 2

Conditions

Colorectal Neoplasms

Treatments

Drug: Capecitabine

Drug: Irinotecan

Drug: Bevacizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT01677884

CSET 2011/1827 (Other Identifier)

2011-005559-15

Details and patient eligibility

About

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

Enrollment

10 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.