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

Metastatic Colorectal Adenocarcinoma Clinical Trial

— Prodige20  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900717
• Other study ID #: Bedenne PHRC K 2010.
• Secondary ID: 2010-022080-34
• Status: Completed
• Phase: Phase 2
• Start date: July 2011
• Est. completion date: March 2016

Study information

• Verified date: December 2018
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Colorectal Adenocarcinoma

Intervention

Drug:
• LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified

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

Locations

Country	Name	City	State
France	CHU de Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	21 days before the first course of treatment
Secondary	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.	14 days before inclusion