Loading clinical trials...

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

COMPLETEDPHASE2

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

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

NCT01900717•Centre Hospitalier Universitaire Dijon

View on ClinicalTrials.gov

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

Age

75 - No limit years

Sex

ALL

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
+2 more criteria

Locations (1)

CHU de Dijon

Dijon, France

Key Dates

Start Date

July 1, 2011

Primary Completion Date

May 1, 2015

Completion Date

March 1, 2016

Last Updated

December 27, 2018

Enrollment

102

ACTUAL participants

Conditions

Metastatic Colorectal Adenocarcinoma

Interventions

LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified

DRUG

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

DRUG

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

NCT06696768

Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

View study

RECRUITINGPHASE1

Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer

NCT04511039

Advanced Malignant Solid NeoplasmClinical Stage III Gastroesophageal Junction Adenocarcinoma+27 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 27, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer

Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer

CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen

Tucatinib Combined with Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study

A Vaccine (PolyPEPI1018 Vaccine) and TAS-102 for the Treatment of Metastatic Colorectal Cancer