Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy

Phase 2

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Drug: Bevacizumab; Drug: Capecitabine; Drug: Irinotecan

• Registration Number: NCT01677884
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-30
• Study First Submitted QC: 2012-08-30
• Study First Posted: 2012-09-03
• Study Start: 2012-11
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-08
• Last Update Posted: 2016-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with metastatic CRC	Bevacizumab	-
Patients with metastatic CRC	Capecitabine	-
Patients with metastatic CRC	Irinotecan	-

Primary Outcome Measures

Name	Time	Method
Efficiency of treatment based on objective response rate	Every 9 weeks from the start to tumoral progression

Secondary Outcome Measures

Name	Time	Method
Treatment toxicity based on NCI-CTC v4.0	Every 3 weeks from the start to tumoral progression or toxicity preventing further processing
Progression Free Survival	Every 9 weeks form the start to tumoral progression
Hepatic metastasis resection rate	Assessed up 6 months after the end of treatment

Trial Locations

Locations (1)

Institut Gustave Roussy; 🇫🇷 Villejuif, Val de Marne, France