Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy (BEVIAC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT01677884
First received: August 30, 2012
Last updated: November 19, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Colorectal Neoplasms
Drug: Bevacizumab
Drug: Capecitabine
Drug: Irinotecan
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • Efficiency of treatment based on objective response rate [ Time Frame: Every 9 weeks from the start to tumoral progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment toxicity based on NCI-CTC v4.0 [ Time Frame: Every 3 weeks from the start to tumoral progression or toxicity preventing further processing ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: Every 9 weeks form the start to tumoral progression ] [ Designated as safety issue: No ]
  • Hepatic metastasis resection rate [ Time Frame: Assessed up 6 months after the end of treatment ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Total area under the curve of contrast-enhanced liver ultrasound [ Time Frame: Assessed up in baseline, D7, D14, W4, W7 and every 9 weeks up to progression ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: November 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bevacizumab
    Every 3 weeks : 7.5 mg/kg intra arterial in 2 hours at D1
    Drug: Capecitabine
    Every 3 weeks: 2000 mg/m²/d in 2 times/d from D1 to D4
    Drug: 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)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677884

Locations
France
Institut Gustave Roussy
Villejuif, Val de Marne, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Michel Ducreux, MD-PhD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01677884     History of Changes
Other Study ID Numbers: 2011-005559-15, CSET 2011/1827
Study First Received: August 30, 2012
Last Updated: November 19, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Capecitabine
Bevacizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 14, 2014