FFCD 1605- OPTIPRIME: A phase II study evaluating FOLFOX + panitumumab according to a ‘stop-and-go’ strategy with a reintroduction loop after progression on fluoropyrimidine as maintenance treatment, as the first line in patients with metastatic colorectal adenocarcinoma without a RAS mutation

Phase 2

Not yet recruiting

• Conditions: metastatic colorectal adenocarcinoma

• Registration Number: 2024-518740-20-00
• Lead Sponsor: Fondation Franc.Cancerologie Digestive

Brief Summary

Evaluate the disease control duration

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-11-13
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 118

Inclusion Criteria

Histologically proven colorectal adenocarcinoma without RAS mutation

PT > 60%, albumin ≥ 25 g/L

Life expectancy ≥ 3 months

Patient affiliated to a social security scheme

Patient informed and informed consent form signed

Confirmed, non-resectable metastatic disease (Stage IV)

No prior chemotherapy except perioperative or adjuvant chemotherapy discontinued for more than 12 months

At least one measurable metastasis according to the RECIST v1.1 criteria

Age ≥ 18 years

WHO ≤ 2

Neutrophils > 1,500 /mm3, platelets > 100,000/mm3, Hb > 9 g/dL

Creatinine clearance > 50 mL/min according to the Cockcroft & Gault formula, 24h proteinuria < 1 g

Serum bilirubin < 25 µmol/L, AST, ALT, Alk Phos < 2.5 x ULN or < 5 x ULN in case of liver metastases

Exclusion Criteria

Presence of brain metastases unless controlled

Any known specific contraindication or allergy to the medicinal products used in the study (see SmPC Annex 7)

Association with the yellow fever vaccine

Patient simultaneously included in another clinical trial involving an investigational drug

High blood pressure not controlled by medical treatment (PAS > 160 mmHg and/or PAD >90 mmHg)

Any progressive disease not stabilised over the past 6 months: hepatic failure, renal failure, respiratory failure

The following conditions in the 6 months prior to inclusion: myocardial infarction, severe/unstable angina, coronary artery bypass surgery, congestive heart failure NYHA class II, III or IV, stroke or transient ischaemic attack

Patient who has received a transplant, is seropositive for HIV, hepatitis B or hepatitis C or has other immunodeficiency syndromes

History of malignant diseases during the past 5 years except basal cell carcinoma of the skin or cervical carcinoma in situ, properly treated

QT/QTc interval > 450 msec for men and > 470 msec for women

K+ < LLN, Mg2+ < LLN, Ca2+ < LLN

RAS mutation (KRAS or NRAS mutation) or BRAF mutation

Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women, women of childbearing age who have not had a pregnancy test. Women of childbearing potential should agree to use a method of contraception during treatment of the trial and at least 4 months after discontinuation of oxaliplatin therapy, at least 2 months after discontinuation of panitumumab therapy and at least 30 days after discontinuation of 5-fluorouracil or capecitabine. Men must agree to use a method of contraception during treatment and at least 6 months after stopping oxaliplatin therapy and at least 3 months after stopping 5-fluorouracil or capecitabine.

Persons in custody or under wardship

Impossibility of undergoing medical monitoring during the trial for geographical, social or psychological reasons

Patient taking warfarin. If treated with an anticoagulant at the indicated effective dose, this must be replaced with low molecular weight heparin before inclusion

Partial or complete DihydroPyrimidine Dehydrogenase (DPD) deficiency (defined as uracilemia ≥16 ng/ml)

Peripheral neuropathy > 1 (NCI CTCAE v4.0)

Patient with interstitial pneumonitis or pulmonary fibrosis

History of chronic diarrhoea or inflammatory disease of the colon or rectum, or obstruction or sub-obstruction during symptomatic treatment

Chronic skin disease poorly controlled

Treatment with sorivudine or its chemically related analogues such as brivudine

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease control duration.		Disease control duration.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival 1 (PFS1 or PFS)		Progression-free survival 1 (PFS1 or PFS)
Progression-free survival 2 (PFS 2)		Progression-free survival 2 (PFS 2)
Successive progression-free survivals (PFS3), 4 (PFS4), etc		Successive progression-free survivals (PFS3), 4 (PFS4), etc
The best tumour response		The best tumour response
The early response rate at 6 weeks		The early response rate at 6 weeks
The depth of response		The depth of response
Overall survival		Overall survival
Quality of life (EORTC QLQ C-30)		Quality of life (EORTC QLQ C-30)
The dose intensity		The dose intensity
The adverse events		The adverse events
The predictive value of early evolution		The predictive value of early evolution
The predictive value of the appearance of resistance mutation(s)		The predictive value of the appearance of resistance mutation(s)

Trial Locations

Locations (2)

Grand Hopital De Charleroi; 🇧🇪 Charleroi, Belgium

Hopitaux Universitaires Pitie Salpetriere; 🇫🇷 Paris, France

Grand Hopital De Charleroi

🇧🇪Charleroi, Belgium

Javier CARRASCO

Site contact

71104732

javier.carrasco@ghdc.be