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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Colorectal Neoplasms

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficiency of treatment based on objective response rate

Outcome Time Frame:

Every 9 weeks from the start to tumoral progression

Safety Issue:

No

Principal Investigator

Michel Ducreux, MD-PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

2011-005559-15

NCT ID:

NCT01677884

Start Date:

November 2012

Completion Date:

November 2016

Related Keywords:

  • Colorectal Neoplasms
  • Neoplasms
  • Colorectal Neoplasms

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