A multicentre randomized phase II study to assess the safety and resectability in patients with primarily unresectable liver metastases secondary to colorectal cancer receiving treatment with 5-FU, leucovorin, oxaliplatin and bevacizumab with or without irinotecan as first line treatment
- Conditions
- Colorectal cancer with primarily unresectable liver metastasesMedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancer
- Registration Number
- EUCTR2007-007863-26-FR
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 80
- Histologically confirmed carcinoma of the colon and/or rectum with evidence of liver
metastases (Note: if time interval from last histological diagnosis to enrolment
exceeds 3 years, new histological confirmation of metastatic disease is required).
- Male and female patients aged greater than or equal to 18 years and less than or
equal to 70 years.
- ECOG performance score of 0 or 1.
- Written informed consent.
- General condition considered feasible for major abdominal surgery after first line
treatment.
- Unresectability of hepatic metastases at randomization (at least one of the
following criteria):
- No upfront R0 resection of all hepatic lesions possible
- Less than 30% estimated residual liver after resection
- Disease in contact with major vessels of the remnant liver.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Diagnosis of metastatic disease more than 3 months prior to study entry.
- Evidence of extrahepatic metastatic disease (excluded by FDG-PET).
- Evidence of diffuse peritoneal carcinosis or involvement of celiac lymph nodes.
- Prior systemic or local treatment of metastatic disease.
- Prior adjuvant or neo-adjuvant chemotherapy/radiotherapy completed less than 6
months prior to study entry.
- Concomitant use with St John's Wort.
- Treatment with any other investigational agent, or participation in another clinical
trial within 30 days prior to entering this study.
- Current or recent (within 10 days of first dose of study treatment) chronic use of
aspirin (> 325 mg/day) or clopidrogel (> 75 mg/day).
- Current or recent (within 10 days prior to study treatment start) use of full-dose
oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed
to prophylactic) purposes.
- History or evidence upon physical/neurological examination of CNS disease
(unrelated to cancer) (unless adequately treated with standard medical therapy)
e.g. uncontrolled seizures.
- Past or current history (within the last 2 years prior to treatment start) of other
malignancies except metastatic colorectal cancer (patients with curatively treated
basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are
eligible).
- Clinically significant cardiovascular disease, for example CVA, myocardial infarction
(less than or equal to 12 months before treatment start), unstable angina, New
York Heart Association (NYHA) greater than or equal to Class II, congestive heart
failure (CHF), arrhythmia requiring medication, or uncontrolled hypertension.
- Evidence of bleeding diathesis or coagulopathy.
- Known hypersensitivity to any of the study drugs.
- Serious, non-healing wound, ulcer or bone fracture.
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days
prior to treatment.
- Central venous access device (CVAD) for chemotherapy administration inserted
within 2 days prior to study treatment start.
- Evidence of any other disease, metabolic dysfunction, physical examination finding
or laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or puts the patient at high risk
for treatment-related complications.
- Life expectancy less than 3 months.
- Inability or unwillingness to comply with the protocol.
- Inadequate haematological function: ANC < 1.5 x 1000000000/L; platelets < 100 x
1000000000/L, Hemoglobin (Hb) < 9 g/dL (may be transfused prior to enrolment).
- INR >1.5 within 7 days prior to starting study treatment. aPTT > 1.5 x ULN within 7
days prior to starting study treatment.
- Liver function: Serum bilirubin > 1.5 x ULN; alkaline phosphatase and
transaminases > 5 x ULN (liver metastases).
- Serum Creatinine > 1.5 x ULN.
- Urine dipstick for proteinuria grater than or equal to 2+. If urine dipstick is greater
than or equal to 2+, 24-hour urine must demonstrate less than or equal to 1 g of
protein in 24 hours for patient to be eligible.
- Pregnancy or lactation.
- Positive serum pregnancy test within 7 days of starting study treatment in
pre-menopausal women and women < 2 years after the onset of menopause.
Note: a negative test has to be reconfirmed by a urine test, should the 7-day
window be exceeded.
- Fertile women (< 2 years after last menstruation) and men of ch
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method