Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01900717
Recruitment Status : Completed
First Posted : July 16, 2013
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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.


Condition or disease Intervention/treatment Phase
Metastatic Colorectal Adenocarcinoma Drug: LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified Drug: LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma
Actual Study Start Date : July 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01900717


Locations
Layout table for location information
France
CHU de Dijon
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01900717     History of Changes
Other Study ID Numbers: Bedenne PHRC K 2010.
2010-022080-34 ( EudraCT Number )
First Posted: July 16, 2013    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Leucovorin
Bevacizumab
Fluorouracil
Oxaliplatin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients