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NCT Number: NCT01900717

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

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.

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Key information

Conditions

Metastatic Colorectal Adenocarcinoma

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Dijon

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified

Drug

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

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: Prodige20

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Jul 16, 2013
Registry last updated
Dec 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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