Colon Cancer - panitumumab - BRAF wild-type

Association details:

Biomarker:	BRAF wild-type
Cancer:	Colon Cancer
Drug:	Vectibix (panitumumab) (EGFR inhibitor)
Direction:	Sensitive

Evidence:

Evidence Level:

Sensitive: A2 - Guideline

New

Source:

NCCN

Excerpt:

Colon Cancer...SYSTEMIC THERAPY FOR ADVANCED OR METASTATIC DISEASE - CHEMOTHERAPY REGIMENS...FOLFIRI + panitumumab (KRAS/NRAS/BRAF WT and left-sided tumors only)...Irinotecan + panitumumab (KRAS/NRAS/BRAF WT and left-sided tumors only)...FOLFOX + panitumumab (KRAS/NRAS/BRAF WT and left-sided tumors only)...FOLFIRINOX or mFOLFIRINOX + panitumumab (KRAS/NRAS/BRAF WT and left-sided tumors only)

Secondary therapy:

FOLFIRINOX; irinotecan; FOLFIRI; FOLFOX

Evidence Level:

Sensitive: C2 – Inclusion Criteria

New

Source:

clinicaltrials.gov

Title:

PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) Tumors

Excerpt:

...Overall Survival`Percentage of Participants With an Objective Response`Duration of Response`Time to Disease Progression`Time to Initial Objective Response`Resection Rate`Progression-free Survival (PFS) in Participants With Wild-type Rat Sarcoma Viral Oncogene Homolog (RAS)`Progression-free Survival (PFS) in Participants With Wild-type RAS / V-raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF)`Overall Survival in Participants With Wild-type RAS`Overall Survival in Participants With Wild-type RAS / BRAF`Percentage of Participants With an Objective Response for Participants With Wild-type RAS`Percentage of Participants With an Objective Response for Participants With Wild-type RAS / BRAF`Number of Participants With Adverse Events (AEs)...

Trial ID:

NCT00819780

Evidence Level:

Sensitive: C2 – Inclusion Criteria

New

Source:

clinicaltrialsregister.eu

Title:

MONARCC: A randomised phase II study of Panitumumab monotherapy and panitumumab plus 5 fluorouracil as first line therapy for RAS and BRAF wild type metastatic colorectal cancer.

Excerpt:

...BRAF wild type as assessed by the investigator’s choice of testing laboratory. ...

Trial ID:

ACTRN12618000233224

More C2 evidence

Evidence Level:

Sensitive: C2 – Inclusion Criteria

New

Source:

clinicaltrialsregister.eu

Title:

The purpose of this clinical research is to compare two different treatments to assess whether the use of a single chemotherapy (5-FU) in combination with panitumumab may provide better results in terms of safety and efficacy compared to treatment with two chemotherapy drugs (5 -fluorouracile and oxaliplatin) in combination with panitumumab as first-line therapy in elderly patients (aged =70 years) with cancer without mutations of RAS and BRAF. Lo scopo di questa ricerca clinica è confrontare due diversi trattamenti per valutare se l’utilizzo di un solo chemioterapico (5-fluorouracile) in associazione a panitumumab possa fornire risultati migliori in termini di tollerabilità ed efficacia rispetto ad un trattamento con due farmaci chemioterapici (5-fluorouracile e oxaliplatino) in associazione a panitumumab come terapia di prima linea nei pazienti anziani (età =70 anni) con neoplasia senza mutazioni dei geni RAS e BRAF.

Excerpt:

...ECOG PS 1 or 2 for patients aged 70 to 75 years; ECOG PS 0 or 1 for patients aged > 75 years.Life expectancy of at least 12 weeks.Previous adjuvant chemotherapy allowed only if with fluoropyrimidine monotherapy and more than 6 months elapsed between the end of adjuvant and first relapse.RAS and BRAF status wild-type of primary colorectal cancer or related metastasis, centrally assessed.Neutrophils =1.5 x 109/L, Platelets =100 x 109/L, Hgb =9 g/dl.Total bilirubin =1.5 time the upper-normal limits (UNL) of the normal values and ASAT (SGOT) and/or ALAT (SGPT) =2.5 x UNL (or <5 x UNL in case of liver metastases) alkaline phosphatase =2.5 x UNL (or <5 x UNL in case of liver metastases).Creatinine clearance =50 mL/min or serum creatinine =1.5 x UNL.Male subjects with female partners of childbearing potential must be willing to use adequate contraception as approved by the investigator (barrier contraceptive measure or oral contraception).Geriatric assessment by means of G8 screening and CRASH score. ...

Trial ID:

2015-003888-10