OPTIMOX-aflibercept as First-line Therapy in Patients With Unresectable Metastatic Colorectal Cancer
This trial is active, not recruiting.
|Condition||unresectable metastatic colorectal cancer|
|Sponsor||Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)|
|Start date||May 2013|
|End date||March 2016|
|Trial size||49 participants|
|Trial identifier||NCT01802684, 2012-003521-25, VELVET C12-1|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Bordeaux, France||Polyclinique de Bordeaux Nord||no longer recruiting|
|Créteil, France||Hôpital Henri Mondor||no longer recruiting|
|Limoges, France||CHU Dupuytren||no longer recruiting|
|Lyon, France||Hôpital Privé Jean Mermoz||no longer recruiting|
|Paris, France||CH Mont de Marsan||no longer recruiting|
|Paris, France||Hôpital Pitié Salpêtrière||no longer recruiting|
|Paris, France||Hôpital Saint-Antoine||no longer recruiting|
|Paris, France||Institut Mutualiste Montsouris||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Progression free survival at 6 months
time frame: time interval from inclusion to the date of first documented disease progression or death from any cause, whichever occurs first. Assessed at 6 months.
Median Progression Free Survival
time frame: time interval from inclusion to the date of first documented disease progression or death from any cause, whichever occurs first. Assessed up to 3 years after the beginning of the study
duration of disease control (DDC)
time frame: sum of PFS of each active treatment course. Assessed up to 3 years after the beginning of the study
time frame: time interval from inclusion to the date of death from any cause. Assessed up to 3 years after the beginning of the study.
tumor Response Rate (RR)
time frame: Assessed every 2 months during treatment period (- Estimated treatment duration per patient : 16 months).
Health related Quality of life
time frame: Assessed from study entry to 1 month after last study drug administration and up to 3 years after the beginning of the study.
time frame: Assessed from study entry to 1 month after last study drug administration, assessed up to 3 years after the beginning of the study
Curative salvage surgery
time frame: assessed up to 3 years after the beginning of the study
Male or female participants at least 18 years old.
- Signed and dated informed consent, and willing and able to comply with protocol requirements,
- Histologically proven adenocarcinoma of the colon and/or rectum,
- Metastatic disease confirmed,
- No prior therapy for metastatic disease (in case of previous adjuvant therapy, interval from end of chemotherapy to relapse must be >6 months for fluoropyrimidine alone or >12 months for oxaliplatin-based, bevacizumab-based, cetuximab-based therapy,
- Duly documented inoperable metastatic disease, ie not suitable for complete carcinological surgical resection,
- At least one measurable or evaluable lesion as assessed by CT-scan or MRI (Magnetic Resonance Imaging) according to RECIST v1.1,
- Age ≥18 years,
- ECOG Performance status (PS) 0-2,
- Hematological status: neutrophils (ANC) ≥1.5x109/L; platelets ≥100x109/L; haemoglobin ≥9g/dL,
- Adequate renal function: serum creatinine level <150µM,
- Adequate liver function: serum bilirubin ≤3 x upper normal limit (ULN), alkaline phosphatase <5xULN,
- Proteinuria <2+ (dipstick urinalysis) or ≤1g/24hour,
- Baseline evaluations: clinical and blood evaluations performed no more than 2 weeks (14 days) prior to confirmation of eligibility, tumor assessment (chest X ray, CT-scan or MRI, evaluation of non-measurable lesions) no more than 3 weeks (21 days) prior to confirmation of eligibility,
- For female patients of childbearing potential, negative serum or urine pregnancy test within 1 week (7 days) prior of starting study treatment,
- Female patients of childbearing potential must commit to using reliable and effective methods of contraception during the trial and until at least six months after the end of study treatment. Females are neither pregnant nor in breastfeeding. Male patients with a partner of childbearing potential must agree to use effective contraception in addition to the contraceptive method used by their partner during the trial and until at least six months after the end of study treatment.
- Registration in a national health care system (CMU included for France).
- History or evidence upon physical examination of CNS metastasis unless adequately treated (e.g. non irradiated CNS metastasis, seizure not controlled with standard medical therapy),
- Exclusive bone metastasis,
- Uncontrolled hypercalcemia,
- Pre-existing permanent neuropathy (NCI grade ≥2),
- Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg despite optimal medical therapy), or history of hypertensive crisis, or hypertensive encephalopathy,
- Concomitant unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy/ radio-immunotherapy),
- Treatment with any other investigational medicinal product within 28 days prior to study entry,
- Other serious and uncontrolled non-malignant disease,
- Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for >5 years,
- Any other serious and uncontrolled non-malignant disease, major surgery or traumatic injury within the last 28 days
- Patients with known allergy to any excipient to study drugs,
- History of myocardial infarction and/or stroke within 6 months prior to study entry,
- Bowel obstruction.
|Official title||OPTIMOX-aflibercept as First-line Therapy in 49 Patients With Unresectable Metastatic Colorectal Cancer. A GERCOR Feasibility Single-arm Phase II Study.|
|Principal investigator||Benoist Chibaudel, MD|
|Description||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.|
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