Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Fluorouracil

Aflibercept

Angiogenesis Inhibitors

Growth Inhibitors

Induction therapy (sequence #1)

* Regimen : aflibercept + modified FOLFOX7
* Duration : 6 cycles (3 months) Maintenance after induction (sequence #2) First phase (sequence #2A)
* Regimen : aflibercept + fluoropyrimidine (simplifed LV5FU2 or capecitabine)
* Duration : 6 cycles (3 months) Second phase (sequence #2B)
* Regimen : aflibercept +/- fluoropyrimidine (simplifed LV5FU2 or capecitabine) according to eligibility criteria for chemotherapy-free interval)
* Duration : until PD or limiting toxicity Reintroduction (sequence #3)
* Regimen : aflibercept + modified FOLFOX7
* Duration : 6 cycles (3 months) Maintenance after reintroduction (sequence #4)
* Regimen : aflibercept + fluoropyrimidine
* Duration : until PD or limiting toxicity

Aflibercept (VEGF Trap) Recombinant human protein, at 25 mg/ml Dose : 4 mg/Kg -Day 1, q2w Route of administration: Intravenous (60 min infusion)

aflibercept

Benoist Chibaudel, MD

Evaluation of feasibility of adding aflibercept to an oxaliplatin-based regimen rather than a continuous administration of chemotherapy until progression, in order to decrease the risk of severe toxicities.

The addition of aflibercept to the standard FOLFIRI regimen as second-line therapy was evaluated in a large phase III study (EFC10262-VELOUR). This new combination significantly improved both PFS (4.7 to 6.9 months, HR=0.76; P=.00007) and OS (12.1 to 13.5 months, HR=0.82; P=.0032). In the evaluable population (86.5%), the tumor response rate was also improved when adding aflibercept (ORR=19.8% \[16.4-23.2\]) to the FOLFIRI regimen (ORR=11.1% \[8.5-13.8\]).

This trial will evaluate the feasibility of adding aflibercept to an oxaliplatin-based regimen as a first-line therapy , using the OPTIMOX strategy rather than a continuous administration of chemotherapy until progression, in order to decrease the risk of severe toxicities.

OPTIMOX-aflibercept as First-line Therapy in Patients With Unresectable Metastatic Colorectal Cancer

OPTIMOX-aflibercept as First-line Therapy in 49 Patients With Unresectable Metastatic Colorectal Cancer. A GERCOR Feasibility Single-arm Phase II Study.

DDC excludes:

* Intervals between disease progression and re-initiation of treatment,
* PFS of inactive treatment if PD occurs at first evaluation after treatment re-initiation

assessed using RECIST version 1.1 per sequence of therapy.

The study will take into account all adverse events observed during and after drug administration, with a particular interest for:

* Any AE
* Any AE related to study treatment
* Any serious AE
* Any serious AE related to study treatment
* Any NCI-CTC grade 3 or 4 AE
* Any NCI-CTC grade 3 or 4 AE related to study treatment
* Any AE causing discontinuation of study treatment
* Any AE causing discontinuation of selected treatment only
* Any AE related to study treatment causing discontinuation
* Any AE causing a dose reduction of study medication
* Any AE leading to death
* Any AE related to study treatment leading to death.

The number of patient with R0 and R1 curative salvage surgery will be assessed globally and per sequence of therapy.

Spots Global Cancer Trial Database for optimox

Every month we try and update this database with for optimox cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for optimox

Every month we try and update this database with for optimox cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for optimox cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.