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

December 26, 2018 updated by: Centre Hospitalier Universitaire Dijon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU de DIJON

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: chimiotherapy alone
  • LV5FU2 simplified,
  • 5-fluorouracil/leucovorin with oxaliplatin 4 (FOLFOX) simplified,
  • fluorouracil, leucovorin, and irinotecan(FOLFIRI) modified.
Drug: LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified
Experimental: chemiotherapy + bevacizumab 5 mg/kg/ 2 weeks
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial examination
Time Frame: 21 days before the first course of treatment

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial examination
Time Frame: 14 days before inclusion

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.
14 days before inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2011

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

July 12, 2013

First Submitted That Met QC Criteria

July 12, 2013

First Posted (Estimate)

July 16, 2013

Study Record Updates

Last Update Posted (Actual)

December 27, 2018

Last Update Submitted That Met QC Criteria

December 26, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bedenne PHRC K 2010.
  • 2010-022080-34 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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