patients with metastatic colorectal cancer MedDRA version: 14.1 Level: PT Classification code 10010035 Term: Colorectal cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: AVASTIN*INFUS 1FL 400MG 16ML
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-75-3
Current Sponsor code: NA
Other descriptive name: NA
Concent
Sponsors
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE "G. PASCALE"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Histological diagnosis of adenocarcinoma of the colon or rectum ? Stage IV of disease ? Presence at least one measurable target lesion (according to the RECIST criteria) not previously treated with radiotherapy. ? Ages > 18 and 3 months ? Adequate recovery from recent surgery (at least 28 days after a major surgery or a biopsy). ? Effective contraception both for male and female patients, if the risk of conception exists. ? Signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: ? More than one line of treatment for metastatic disease. ? Previous treatment with bevacizumab or oxaliplatin (a previous treatment with fluoropirymidines, folic acid, irinotecan or cetuximab is allowed). ? Presence of primary colorectal cancer that produces stenosis or full-thickness wall infiltration. ? Regular use of NSAID or aspirin (more than 325 mg/die). ? Bleeding diathesis or pre-existing coagulopathy. ? Use of anticoagulants at therapeutic dose. ? Known or suspected brain metastases ( determined exclusively in the presence of at least one clinical symptom) ? Neutrophils 1.5 time the upper normal limit (UNL). ? GOT and/or GPT > 2.5 time the UNL and/or bilirubin >1.5 time the UNL in absence of liver metastasis. ? GOT and/or GPT > 5 time the UNL and/or bilirubin > 3 time the UNL in presence of liver metastasis ? Any concurrent malignancy other than non-melanomatous skin cancer, or carcinoma in situ of the cervix. Patients with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial. ? Congestive heart failure, recent ischemic coronary disease (in the last 12 months), uncontrolled arrhythmia. ? Uncontrolled hypertension. ? Active or uncontrolled infection. ? A serious uncontrolled medical disorder that in the opinion of the investigator would impair the ability of the subject to receive protocol therapy. ? Pregnancy (absence to be confirmed by B-HCG test) or lactation period. ? History or current evidence on physical examination of central nervous system disease or Peripheral Neuropathy > Grade 1 (CTCAE v. 4.0) ? Unable to comply with follow-up
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Progression free survival (PFS) - Overall survival (OS). - Toxicity. - Quality of life;Timepoint(s) of evaluation of this end point: na | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To assess whether an experimental schedule of bevacizumab, given in sequence instead of in combination with oxaliplatin regimen (mFOLFOX/mOXXEL), can improve treatment activity (in terms of objective response rate) in patients with metastatic colorectal cancer;Secondary Objective: •To evaluate the impact of the experimental schedule on: - Progression free survival (PFS) - Overall survival (OS). - Toxicity. - Quality of life. •To evaluate prognostic and predictive value of : -Circulating endothelial cells (CEC) and Circulating endothelial precursor cells (CEP) count on patient blood samples. -Cytokine and circulating angiogenic factors plasma levels on patient blood samples. -Single nucleotide polymorphisms (SNPs) of VEGF on patient blood samples. -WBC counts at 24 hours after the 1st administration of bevacizumab on patient blood samples. -microRNAs (miRNAs) on patient blood samples.;Primary end point(s): Primary end point is objective response rate (RR) according to RECIST criteria;Timepoint(s) of evaluation of this end point: at week 12 and 24 | — |
Countries
Italy
Contacts
Public ContactUnita' Sperimentazioni Cliniche
Istituto Nazionale Tumori di Napoli
Outcome results
None listed