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

Primary Purpose

Metastatic Colorectal Adenocarcinoma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified
LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metastatic Colorectal Adenocarcinoma

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Dijon

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

chimiotherapy alone

chemiotherapy + bevacizumab 5 mg/kg/ 2 weeks

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Initial examination
Medical history, clinical examination (HR, arterial blood pressure , temperature, weight, height, Eastern Cooperative Oncology Group performance status), measurement of body surface area, ECG completion of questionnaire by the patient (annexe 1), completion of geriatric questionnaire "team" (annexe 2) biological examination including: full blood count-platelets blood electrolyte panel, creatinemia Albumin ASAT, ALAT, PAL, GGT, total and conjugated bilirubin CEA, CA 19.9, LDH markers balanced INR for patients on AVK Urinary dip with 24-hour proteinuria if > 1+ Measurement of creatinine clearance using the Cockcroft formula (in men: (140-age) x weight (kg)/0.814 x creatinemia (μmol), in women: (140-age) x weight (kg)/0.85 x creatinemia (μmol)), In the absence of a cardiological examination in the year before or in the case of a history of severe cardiovascular disease: consultation in cardiology.

Full Information

First Posted
July 12, 2013
Last Updated
December 26, 2018
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT01900717
Brief Title
Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma (Prodige20)
Acronym
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
July 2011 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Adenocarcinoma

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
chimiotherapy alone
Arm Type
Active Comparator
Arm Description
LV5FU2 simplified, 5-fluorouracil/leucovorin with oxaliplatin 4 (FOLFOX) simplified, fluorouracil, leucovorin, and irinotecan(FOLFIRI) modified.
Arm Title
chemiotherapy + bevacizumab 5 mg/kg/ 2 weeks
Arm Type
Experimental
Arm Description
LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified. Bevacizumab 5 mg/kg/ 2 weeks
Intervention Type
Drug
Intervention Name(s)
LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified
Intervention Type
Drug
Intervention Name(s)
LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks
Primary Outcome Measure Information:
Title
Initial examination
Description
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.
Time Frame
21 days before the first course of treatment
Secondary Outcome Measure Information:
Title
Initial examination
Description
Medical history, clinical examination (HR, arterial blood pressure , temperature, weight, height, Eastern Cooperative Oncology Group performance status), measurement of body surface area, ECG completion of questionnaire by the patient (annexe 1), completion of geriatric questionnaire "team" (annexe 2) biological examination including: full blood count-platelets blood electrolyte panel, creatinemia Albumin ASAT, ALAT, PAL, GGT, total and conjugated bilirubin CEA, CA 19.9, LDH markers balanced INR for patients on AVK Urinary dip with 24-hour proteinuria if > 1+ Measurement of creatinine clearance using the Cockcroft formula (in men: (140-age) x weight (kg)/0.814 x creatinemia (μmol), in women: (140-age) x weight (kg)/0.85 x creatinemia (μmol)), In the absence of a cardiological examination in the year before or in the case of a history of severe cardiovascular disease: consultation in cardiology.
Time Frame
14 days before inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31101691
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.
Results Reference
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Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma (Prodige20)

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