Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma (Prodige20)

NCT01900717 | Completed Phase 2

• 2 other identifiers: Bedenne PHRC K 2010.2010-022080-34
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Initial examination

  thoraco-abdomino-pelvic tomodensitometry or thoracic tomodensitometry and abdomino-pelvic MRI with identification and measurement of the target tumors according to RECIST (Response Evaluation Criteria in Solid Tumors )criteria.

  21 days before the first course of treatment

Secondary Outcomes (1)

• Initial examination

  14 days before inclusion

Study Arms (2)

chimiotherapy alone

ACTIVE COMPARATOR

* LV5FU2 simplified, * 5-fluorouracil/leucovorin with oxaliplatin 4 (FOLFOX) simplified, * fluorouracil, leucovorin, and irinotecan(FOLFIRI) modified.

Drug: LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified

chemiotherapy + bevacizumab 5 mg/kg/ 2 weeks

EXPERIMENTAL

* LV5FU2 simplified, * FOLFOX 4 simplified, * FOLFIRI modified. * Bevacizumab 5 mg/kg/ 2 weeks

Drug: LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks

Interventions

LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified DRUG

chimiotherapy alone

LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks DRUG

chemiotherapy + bevacizumab 5 mg/kg/ 2 weeks

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU de Dijon

Dijon, 21079, France

Location

Related Publications (1)

• 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.

  PMID: 31101691 DERIVED

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: July 16, 2013
• Study Start: July 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: March 1, 2016
• Last Updated: December 27, 2018

Record last verified: 2018-12

Locations

FR (1)