Bevacizumab-based Chemotherapy Adapted to Bevacizumab Pharmacokinetics in 1st-line Treatment
NCT ID: NCT06642844
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
244 participants
INTERVENTIONAL
2024-10-30
2029-10-30
Brief Summary
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Detailed Description
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This project is a multicenter, double-blind, randomized trial in two parallel groups.
The primary endpoint is progression-free survival (PFS)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
The dose of bevacizumab will be administered in 2 preparations and in the following order:
* 1\. Preparation at 5 mg/kg, open label;
* 2\. Preparation at 5 mg/kg or placebo, blinded.
Study Groups
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Experimental: Group A
Patients randomized to the experimental group of the trial will receive bevacizumab as an IV infusion at a dose of 10 mg/kg, administered in 2 preparations of 5 mg/kg, every 2 weeks. Patients will receive treatment until progression, patient refusal, or unacceptable toxicity.
Avastin, 25 Mg/mL Intravenous Solution
Experimental group/ Patients randomized to the experimental group of the trial will receive bevacizumab as an IV infusion at a dose of 10 mg/kg, administered in 2 preparations of 5 mg/kg, every 2 weeks. Patients will receive treatment until progression, patient refusal, or unacceptable toxicity.
Control group: Patients randomized to the control group of the trial will receive bevacizumab at a dose of 5 mg/kg and placebo (NaCl) every two weeks. Patients will receive treatment until progression, patient refusal, or unacceptable toxicity.
Active comparator: Group B
Patients randomized to the control group of the trial will receive bevacizumab at a dose of 5 mg/kg and placebo (NaCl) every two weeks. Patients will receive treatment until progression, patient refusal, or unacceptable toxicity.
Avastin, 25 Mg/mL Intravenous Solution
Experimental group/ Patients randomized to the experimental group of the trial will receive bevacizumab as an IV infusion at a dose of 10 mg/kg, administered in 2 preparations of 5 mg/kg, every 2 weeks. Patients will receive treatment until progression, patient refusal, or unacceptable toxicity.
Control group: Patients randomized to the control group of the trial will receive bevacizumab at a dose of 5 mg/kg and placebo (NaCl) every two weeks. Patients will receive treatment until progression, patient refusal, or unacceptable toxicity.
Interventions
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Avastin, 25 Mg/mL Intravenous Solution
Experimental group/ Patients randomized to the experimental group of the trial will receive bevacizumab as an IV infusion at a dose of 10 mg/kg, administered in 2 preparations of 5 mg/kg, every 2 weeks. Patients will receive treatment until progression, patient refusal, or unacceptable toxicity.
Control group: Patients randomized to the control group of the trial will receive bevacizumab at a dose of 5 mg/kg and placebo (NaCl) every two weeks. Patients will receive treatment until progression, patient refusal, or unacceptable toxicity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically proven metastatic colorectal adenocarcinoma (on primary tumor and/or metastases) inoperable, well documented, i.e. not compatible with complete oncological resection at inclusion.
* For whom treatment with bevacizumab is indicated.
* For women of childbearing age: effective contraception.
* ECOG Performance status (PS) 0-2.
* No prior treatment of metastatic disease (in the case of adjuvant treatment, interval between the end of chemotherapy and relapse \> 6 months if fluoropyrimidine alone or \> 12 months if FOLFOX).
* At least one evaluable or measurable lesion assessed by computed tomography (CT) according to RECIST v1.1 criteria.
* Life expectancy greater than 3 months.
* Adequate hematological, renal and hepatic biological parameters: neutrophils ≥ 1.5x109/L; platelets ≥ 100x109/L; hemoglobin ≥ 9 g/dL; serum creatinine \<150 μmol/L; bilirubinemia ≤ 1.5 x upper limit of normal (ULN), alkaline phosphatase \< 5xULN; proteinuria \< 2+ (urine dipstick) or ≤ 1 g/24h.
* Written informed consent signed by the patient.
* Patient affiliated to a French social security system.
Randomization criteria in the experimental phase:
\- Serum concentration of bevacizumab on D14 ≤ 15.5 mg/L (measured just before the 2nd infusion of bevacizumab).
Exclusion Criteria
* Patient with a known non-indication or contraindication to first-line chemotherapy based on bevacizumab.
* Cardiovascular contraindication to the prescription of bevacizumab: heart failure, cardiovascular event within 6 months, NYHA ≥ 2 (New York Heart Association), poorly controlled arterial hypertension, history of hypertensive crisis or hypertensive encephalopathy; Grade 3/4 anterior venous thromboembolism (NCI-CTCAE)
* Inadequate hematological, hepatic and renal function
* Urine test strip for proteinuria ≥ 2+ unless proteinuria \< 1 g / 24 hours is demonstrated.
* Current or recent (within 10 days of study enrollment) use of aspirin (\>325 mg/day) or clopidogrel (\>75 mg/day).
* Current or recent use (within 10 days before the first dose of bevacizumab) of oral or parenteral therapeutic anticoagulants or thrombolytic agents for therapeutic purposes.
* Untreated CNS metastases or treatment of brain metastases, either by surgical or radiological techniques, must have been completed more than 4 weeks before the first study treatment.
* Surgical procedure (including open biopsy, surgical resection, wound revision, or other major surgery involving entry into a body cavity) or significant traumatic injury within 28 days prior to study enrollment or anticipation of study need for major surgery during the study.
* Serious non-healing wound, active ulcer or untreated bone fracture.
* Other neoplasias (previous or current), except:
* i/ carcinoma in situ of the cervix adequately treated,
* ii/ basal cell or squamous cell carcinoma of the skin,
* iii/ cancer in complete remission for more than 5 years.
* Other illnesses, which, according to the doctor, are life-threatening to the patient and/or which are uncontrolled.
* Primary tumor in place and symptomatic (occlusion, hemorrhage).
* Pregnant or breastfeeding women.
* Patients unable to give consent.
* Patients under guardianship, curatorship or legal protection.
18 Years
99 Years
ALL
No
Sponsors
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CHU DE BESANCON
UNKNOWN
Gustave Roussy, Cancer Campus, Grand Paris
OTHER
CHU de Clermont-Ferrand
UNKNOWN
CHU de Reims
OTHER
CHU de Brest
UNKNOWN
AP-HP, Hôpital Pitié- Salpétrière
UNKNOWN
University Hospital, Rouen
OTHER
Poitiers University Hospital
OTHER
Institut Paoli-Calmettes
OTHER
Rennes University Hospital
OTHER
University Hospital, Toulouse
OTHER
AP-HP, Hôpital Saint-Louis
UNKNOWN
HCL Hôpital Edouard Hériot
UNKNOWN
Centre Hospitalier Universitaire Dijon
OTHER
Nantes University Hospital
OTHER
Centre Hospitalier Universitaire, Amiens
OTHER
Hôpital Privé Jean Mermoz
UNKNOWN
AP-HP, Hôpital Henri Mondor
UNKNOWN
AP-HP, Hôpital Paul Brousse
UNKNOWN
CHG de St-Malo
UNKNOWN
Polyclinique de Blois
UNKNOWN
University Hospital, Caen
OTHER
Central Hospital, Nancy, France
OTHER
University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Christophe Borg
Role: PRINCIPAL_INVESTIGATOR
Besançon, FRANCE
Michel Ducreux
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, FRANCE
Caroline Petorin
Role: PRINCIPAL_INVESTIGATOR
Clermont-Ferrand, FRANCE
Olivier Bouché
Role: PRINCIPAL_INVESTIGATOR
Reims, FRANCE
Jean-Philippe Metges
Role: PRINCIPAL_INVESTIGATOR
Brest, FRANCE
Jean-Baptiste Bachet
Role: PRINCIPAL_INVESTIGATOR
Pitié- Salpétrière, FRANCE
Frédéric Di Fiore
Role: PRINCIPAL_INVESTIGATOR
Rouen, FRANCE
David Tougeron
Role: PRINCIPAL_INVESTIGATOR
Poitiers, FRANCE
Astrid Lièvre
Role: PRINCIPAL_INVESTIGATOR
Rennes, FRANCE
Rosine Guimbaud
Role: PRINCIPAL_INVESTIGATOR
Toulouse , FRANCE
Thomas Aparicio
Role: PRINCIPAL_INVESTIGATOR
St Louis , FRANCE
Thomas Walter
Role: PRINCIPAL_INVESTIGATOR
Edouard Hériot, FRANCE
Côme Lepage
Role: PRINCIPAL_INVESTIGATOR
Dijon, FRANCE
Yann Touchefeu
Role: PRINCIPAL_INVESTIGATOR
Nantes, FRANCE
Vincent Hautefeuille
Role: PRINCIPAL_INVESTIGATOR
Amiens, FRANCE
Pascal Artru
Role: PRINCIPAL_INVESTIGATOR
Jean Mermoz, FRANCE
Christophe Tournigand
Role: PRINCIPAL_INVESTIGATOR
Henri Mondor, France
Pascal Hammel
Role: PRINCIPAL_INVESTIGATOR
Paul Brousse, FRANCE
Romain Desgrippes
Role: PRINCIPAL_INVESTIGATOR
St-Malo, FRANCE
Philippe Laplaige
Role: PRINCIPAL_INVESTIGATOR
Blois, FRANCE
Karine Bouhier-Leporrier
Role: PRINCIPAL_INVESTIGATOR
Caen, FRANCE
Marie Muller
Role: PRINCIPAL_INVESTIGATOR
Nancy, france
Central Contacts
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Other Identifiers
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DR230009
Identifier Type: -
Identifier Source: org_study_id
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