Unresectable and metastatic colorectal cancer MedDRA version: 16.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Avastin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-75-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration ty
Sponsors
S.I.C.O.G. ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent Patients with histologic or cytologic diagnosis of metastatic colorectal cancer surgery is not likely to colorectal carcinoma metastatic or locally advanced unresectable At least one measurable lesion according to the RECIST (Response Evaluation Criteria in Solid Tumors) Adjuvant treatment should be completed = 6 months before study entry Age = 18 years ECOG performance status 0 or 1 Renal function, hepatic and haematological normal at the time of study entry and initiation of therapy, in accordance with the guidelines Using contraceptive methods during the study (for those of childbearing age and their partners) 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 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: Absence of written informed consent. Prior treatment with bevacizumab Hypersensitivity to any of the medications , or components of the study In recent treatment or treatment (up to 4 weeks before the starting of the infusion of study drug ) with other experimental drugs History of other malignancy (except squamous or basal cell carcinoma of the skin, in situ carcinoma of the cervix or in situ carcinoma of the colon or rectum treated effectively ) unless there has been a complete remission and both outside therapy for malignant disease from at least 5 years . Brain metastases or spinal cord compression Previous treatment for metastatic colorectal cancer Previous treatment with anti- angiogenetic agents as adjuvant or metastatic Concomitant use of anti-neoplastic agents being tested (up to 4 weeks prior to enrollment) Medical or psychiatric disorders that could interfere with the informed consent or patient compliance for participation in this study and its procedures for follow-up Active infections requiring antibiotic therapy on day 1 Severe cardiovascular disease grade II or greater according to the classification New York Heart Association (NYHA ) Evidence of bleeding diathesis or coagulopathy Peripheral neuropathy of grade > 1 (according to the NCI CTCAE , v3.0 ) Lack of physical integrity of the upper gastrointestinal tract , or history of malabsorption syndrome Blood pressure > 150/100 mmHg Major surgical procedures , biopsies open or significant trauma up to 30 days before compared to day 1 of therapy ; need to anticipate a major surgery during the study period Minor surgical procedures such as fine needle biopsy (FNA) biopsy or up to 7 days before the start of therapy Proteinuria , serum creatinine > = 1.0 at study entry History of abdominal fistula , gastrointestinal perforation or intra-abdominal abscess up to 6 months before the start of the study Serious wounds , ulcers or bone fractures History of myocardial infarction up to 6 months before the start of therapy Day 1 Unstable angina Peripheral vascular disease clinically important History of stroke up to 6 months before the first day of therapy Women pregnant ( positive pregnancy test ) or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression free survival;Secondary Objective: Time to treatment failure, response rate, response duration, safety, toxicity, 2-years and 5-yaers Overall survivall ;Primary end point(s): Progression free survival;Timepoint(s) of evaluation of this end point: PFS will be assessed according to RECIST criteria every 6 cycles (3 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Assuming that the average Time to Treatment Failure TTF is 6 months in regimens containing B-FOLFIRI, we determined that in the experimental arm we want to get a time to failure of the therapeutic strategy of 9 months Response rate: 45-50% in regimens containing FOLFIRI-B-, with the experimental arm we want to get a 15% increase Compliance and duration of treatment: historical average of 50% of patients performing 11-12 cycles in regimens containing B-FOLFIRI, we want to get in the ex perimental arm at least 75% of patients performing all 12 cycles expectedof induction treatment ; Safety: With the experimental arm we want to reduce by 50% the overall AEs of grade 3/4;Timepoint(s) of evaluation of this end point: TTF: continuous during the study Response rate and duration:every 3 months Safety and toxicity: evaluation every 2-3 weeks Overall survival: continuous during the study | — |
Countries
Italy
Contacts
Public ContactData Management
S.I.C.O.G. ONLUS
Outcome results
None listed