Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy

Colorectal Neoplasms Clinical Trial

— BEVIAC  

Official title:

Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy in Hepatic Metastases of Metastatic Colorectal Cancer: a Phase II Multicentric Study With Patients in Progression After First Line Systemic Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677884
• Other study ID #: 2011-005559-15
• Secondary ID: CSET 2011/1827
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2012
• Last updated: June 8, 2016
• Start date: November 2012
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Drug:
• Bevacizumab
Every 3 weeks : 7.5 mg/kg intra arterial in 2 hours at D1
• Capecitabine
Every 3 weeks: 2000 mg/m²/d in 2 times/d from D1 to D4
• Irinotecan
Every 3 weeks: 200mg/m² in 30mn IV at D1 (if oxaliplatin in first line) or oxaliplatin 130mg/m² in 2h IV at D1 (if irinotecan in first line)

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif	Val de Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total area under the curve of contrast-enhanced liver ultrasound		Assessed up in baseline, D7, D14, W4, W7 and every 9 weeks up to progression	No
Primary	Efficiency of treatment based on objective response rate		Every 9 weeks from the start to tumoral progression	No
Secondary	Treatment toxicity based on NCI-CTC v4.0		Every 3 weeks from the start to tumoral progression or toxicity preventing further processing	No
Secondary	Progression Free Survival		Every 9 weeks form the start to tumoral progression	No
Secondary	Hepatic metastasis resection rate		Assessed up 6 months after the end of treatment	No