Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy

NCT01677884 | Completed Phase 2 DMC

• 2 other identifiers: 2011-005559-15CSET 2011/1827
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Efficiency of treatment based on objective response rate

  Every 9 weeks from the start to tumoral progression

Secondary Outcomes (3)

• 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

Other Outcomes (1)

• 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

Study Arms (1)

Patients with metastatic CRC

EXPERIMENTAL

Drug: Bevacizumab; Drug: Capecitabine; Drug: Irinotecan

Interventions

Bevacizumab DRUG

Every 3 weeks : 7.5 mg/kg intra arterial in 2 hours at D1

Patients with metastatic CRC

Capecitabine DRUG

Every 3 weeks: 2000 mg/m²/d in 2 times/d from D1 to D4

Patients with metastatic CRC

Irinotecan DRUG

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)

Patients with metastatic CRC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Institut Gustave Roussy

Villejuif, Val de Marne, 94805, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Capecitabine; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Camptothecin; Alkaloids

Study Officials

• Michel Ducreux, MD-PhD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 3, 2012
• Study Start: November 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 9, 2016

Record last verified: 2016-06

Locations

FR (1)