Clinical trial NCT01900717: Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma (Prodige20)
Official title: Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colorectal Adenocarcinoma
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-07-16
Enrollment: 102
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To evaluate tolerance to and efficacy of bevacizumab in the treatment of MCRC in elderly patients, we propose a phase II randomised study comparing a chemotherapy + bevacizumab arm with a chemotherapy alone arm in the first-line treatment of MCRC in patients aged 75 years and older.

This study is destined to continue as a phase III trial if both arms meet the selection criteria to show or not the benefits of treatment with bevacizumab combined with chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients aged 75 years or older
* ECOG ≤2
* histologically proven unresectable metastatic colorectal adenocarcinoma
* Measurable lesion according to RECIST criteria
* Absence of prior chemotherapy for metastatic disease. Adjuvant chemotherapy following resection of the primary tumor is authorized if completed more than 6 months previously
* Patients treated with anticoagulants (coumadin, warfarin) can be included if close surveillance of the INR can be ensured. A change to low-molecular-weight heparin is preferable as long as the indications are respected
* Completed geriatric self-questionnaire
* Completed "Team" geriatric questionnaire (including Spitzer QoL Index)
* Written informed consent

Exclusion Criteria:

* Estimated life expectancy \< 3 months
* Non-resolved intestinal occlusion or sub-occlusion
* Cerebral metastasis
* Other evolutive malignant tumor (non-stabilized cancer for less than 2 years)
* Evolutive gastroduodenal ulcer, wound or bone fracture
* Active heart disease: uncontrolled hypertension, myocardial infarction In the previous 6 months, angina, non-compensated congestive heart failure
* Major surgery, except for biopsy, or irradiation in the 4 weeks preceding the start of treatment
* Polynuclear neutrophils \<1500/mm3, platelets \<100 000/mm3 or 24-h proteinuria \> 1g
* History of arterial thromboembolic event (cerebrovascular accident, transient ischemic attack, subarachnoid hemorrhage) in the 12 months preceding the first dose of bevacizumab
* History of distal or visceral ischemia ≥ grade 2 in the 12 months preceding the first dose of bevacizumab
* History of life-threatening pulmonary embolism in the 6 months preceding the first dose of bevacizumab
* Impossibility to ensure regular follow-up

Primary outcomes:
measure: Initial examination
timeFrame: 21 days before the first course of treatment
Secondary outcomes:
measure: Initial examination
timeFrame: 14 days before inclusion
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de Dijon
Study officials:
References:
citation: Dohan A, Gallix B, Guiu B, Le Malicot K, Reinhold C, Soyer P, Bennouna J, Ghiringhelli F, Barbier E, Boige V, Taieb J, Bouche O, Francois E, Phelip JM, Borel C, Faroux R, Seitz JF, Jacquot S, Ben Abdelghani M, Khemissa-Akouz F, Genet D, Jouve JL, Rinaldi Y, Desseigne F, Texereau P, Suc E, Lepage C, Aparicio T, Hoeffel C; PRODIGE 9 Investigators and PRODIGE 20 Investigators. Early evaluation using a radiomic signature of unresectable hepatic metastases to predict outcome in patients with colorectal cancer treated with FOLFIRI and bevacizumab. Gut. 2020 Mar;69(3):531-539. doi: 10.1136/gutjnl-2018-316407. Epub 2019 May 17.