Actively Recruiting
Intermittent or Continuous Panitumumab Plus FOLFIRI for Left Sided RAS/B-RAF Wild-type Metastatic Colorectal Cancer
Led by National Cancer Institute, Naples · Updated on 2024-07-19
500
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The investigators hypothesize that intermittent first-line Panitumumab plus FOLFIRI is effective in first line as the same regimen given continuously, resulting in a Time to Treatment Failure (TTF) not inferior to that obtained with standard continuous regimen of Panitumumab plus FOLFIRI, in the treatment of metastatic left sided RAS/B-RAF wild-type colorectal cancer patients. Correlative mechanistic studies on tissue and blood samples, liquid biopsies, could identify potential biomarkers of efficacy and help understanding the evolutionary dynamics of tumors in response to therapy thus optimizing the treatment approach with a personalized anti-EGFR treatment strategy.
CONDITIONS
Official Title
Intermittent or Continuous Panitumumab Plus FOLFIRI for Left Sided RAS/B-RAF Wild-type Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent for study participation and correlative studies
- Have histologically confirmed left sided metastatic colorectal cancer
- Confirm RAS/BRAF wild-type and pMMR and/or MSS status by a validated local test
- Disease must be considered unresectable by a multidisciplinary team
- Be eligible to receive induction treatment with FOLFIRI plus panitumumab
- Have not received prior treatments for metastatic colorectal cancer; prior surgery for primary tumor allowed
- Be aged 18 years or older
- Have an ECOG Performance Status of 0 or 1 at study entry
- Have measurable disease documented by imaging according to RECIST 1.1
- Known activity of dihydropyrimidine dehydrogenase (DPYD) enzyme
- Adequate bone marrow function with ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, and hemoglobin ≥ 9 g/dL
- Adequate liver function with bilirubin ≤ 1.5 x ULN (or ≤ 2 with biliary stent) and AST/ALT ≤ 5 x ULN
- Adequate renal function with serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min (males) or ≥ 50 mL/min (females)
- Electrolytes within normal laboratory ranges (magnesium, calcium, sodium, potassium)
You will not qualify if you...
- Prior malignancy within the last 5 years except for treated basal or squamous cell skin cancer or in situ cervical cancer
- Prior chemotherapy or medical treatment for metastatic colorectal cancer (except adjuvant chemotherapy completed > 6 months ago)
- Major surgery within 4 weeks prior to enrollment
- Pregnancy or breastfeeding
- Presence of brain metastases
- Complete deficiency of DPYD activity or known UGT1A1 homozygosity
- Previous dose reductions of 5-fluorouracil due to toxicity
- Severe or uncontrolled systemic diseases or conditions that would impair study participation or compliance
- History of poor cooperation, non-compliance, or inability to understand informed consent
- Participation in another interventional drug or device study within 30 days prior to treatment
- Sexually active males or females of childbearing potential unwilling to use contraception during and for 6 months after the study
- History of interstitial pneumonitis or pulmonary fibrosis
- History of corneal perforation or ulcerative keratitis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale
Naples, Italy, 80131
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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