2nd-line Treatment of Metastatic Colorectal Cancer (BEVATOMOX)

Institut du Cancer de Montpellier - Val d'Aurelle

Status and phase

Terminated

Phase 2

Conditions

Metastatic Colorectal Cancer

Treatments

Drug: Bevacizumab, oxaliplatin and raltitrexed combination

Drug: bevacizumab, oxaliplatin and 5FU combination

Study type

Interventional

Funder types

Other

Identifiers

NCT01532804

2010-023447-15 (EudraCT Number)

BEVATOMOX

Details and patient eligibility

About

This phase 2 trial aims to evaluate the continued use of bevacizumab with raltitrexed and oxaliplatin combination versus FOLFOX6 plus bevacizumab in patients with metastatic colorectal cancer whose disease has progressed after irinotecan-based chemotherapy.

Full description

Eligible patients are randomly allocated to receive either bevacizumab with raltitrexed and oxaliplatin combination or bevacizumab with FOLFOX 6 combination. Random allocation schedule is performed using a minimization technique for the following stratification factors:

Center
Number of metastatic sites: 1 versus > 1
Bevacizumab-based first-line therapy: Yes versus No

Enrollment

83 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically proven colorectal cancer
Resected or asymptomatic primary tumor
Metastatic colorectal cancer not eligible for curative surgery
No major surgery within four weeks of the start of study treatment
At least one target lesion unidimensionally measurable on cross-sectional imaging according to RECIST criteria (v1.1)
Disease progression after failure of irinotecan-based chemotherapy
Bone metastases are allowed if there is at least one other measurable metastatic site
CT scan of the abdomen, chest and pelvis within 3 weeks of the start of study treatment
WHO PS ≤ 2
Platelet count >= 100,000 mm3
Hemoglobin > 10g/dl
Bilirubin < 1.5 ULN, AST/ALT < 5 ULN
Serum creatinine < 1.5 ULN, creatinine clearance > 60 ml/min (Cockcroft)
A time period of 4 weeks should be respected between the end of previous treatments and study enrollment
Negative pregnancy test in women of childbearing potential
Male or female using an effective contraceptive method
Absence of known or symptomatic brain metastases
Life expectancy > 3 months
Informed consent signed prior any study specific procedures

Exclusion criteria

Prior raltitrexed-based chemotherapy
Prior oxaliplatin-based chemotherapy (except for adjuvant treatment completed for more than 6 months)
Uncontrolled arterial hypertension defined as systolic pressure > 150 mm Hg or diastolic pressure > 100 mm Hg
Malignant hypertension or hypertensive encephalopathy
Myocardial infarction, pulmonary embolism, or severe vascular disease within 6 months prior to study entry
Hemorrhagic diathesis or significant pathology of coagulation
Peripheral neuropathy grade>2 (NCI-CTC v4.0)
Hemoptysis < 1 month
Venous access device (PAC) or any other minor surgery such as a biopsy within the last 7 days
Symptomatic brain metastases or carcinomatous meningitis
History or presence of other cancer within the past 5 years (except curatively treated nonmelanoma skin cancer and in situ cervical cancer)
Severe bacterial or fungal infection (Grade > 2 NCI-CTCAE v.4.0)
Known or suspected sensitivity to one of the study drugs
Pregnant or breastfeeding women
Previous enrollment in an investigational drug study within the last 4 weeks
Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment administration and study follow-up)