Randomized phase 3 study on the optimization of the combination of bevacizumab with FOLFOX/OXXEL in the treatment of patients with metastatic colorectal cancer

• Conditions: patients with metastatic colorectal cancer; MedDRA version: 14.1Level: PTClassification code 10010035Term: Colorectal cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-004997-27-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-08
• Last Update Posted: 17 December 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 < 75 years
? ECOG performance status 0 or 1 at study entry
? Life expectancy > 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

?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 < 2000/mm3 or platelets < 100.000/ mm3 or haemoglobin <9 gr/dl.
?Creatinine >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified