Status:
NOT_YET_RECRUITING
Optimal Anti-EGFR Treatment of mCRC Patients With Low-Frequency RAS Mutation
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Collaborating Sponsors:
Amgen
ClinAssess GmbH
Conditions:
Treatment Related Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The present hypothesis is that anti-EGFR agents are active in tumors with low-level RAS mutation when the majority of tumor cells is still sensitive. While response rate may be high and may reflect se...
Eligibility Criteria
Inclusion
- Histologically confirmed, UICC stage IV metastatic adenocarcinoma of the colon or rectum
- Primarily non-resectable metastases or surgical resection refused by the patient
- RAS mutation determined by the local pathology
- Age ≥18
- ECOG performance status 0-2
- Patients suitable for chemotherapy administration
- Patient's written declaration of consent obtained
- Estimated life expectancy \> 3 months
- Presence of at least one measurable reference lesion according to the RECIST 1.1 criteria
- Primary tumor tissue available and patient consents to storage and molecular and genetic profiling of tumor material. Molecular profiling of blood samples is optionally performed.
- Adequate bone marrow function:
- Leukocytes ≥ 3.0 x 109/L with neutrophils ≥ 1.5 x 109/L
- Thrombocytes ≥ 100 x 109/L
- Haemoglobin ≥ 5.6 mmol/L (equivalent to 9 g/dL)
- Adequate hepatic function:
- Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
- ALAT and ASAT ≤ 2.5 x ULN (in the presence of hepatic metastases, ALAT and ASAT ≤ 5 x ULN)
- Adequate renal function:
- ▫ Creatinine clearance (calculated according to Cockcroft and Gault) ≥ 50 mL/min
- No previous chemotherapy for metastatic disease. Patient with need of immediate treatment (high tumor load, symptoms) may have received one application of FOLFIRI prior to study treatment.
Exclusion
- Previous chemotherapy for metastatic disease with the exception of one cycle of FOLFIRI (e.g. while waiting for the result of RAS mutation frequency).
- Patients planned to be treated with FOLFOX or another oxaliplatin-based regimen as first-line treatment
- Primarily resectable metastases and the patient agrees to resection
- Grade III or IV heart failure (NYHA classification)
- Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study
- Previous chemotherapy for the colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before entering the study
- Participation in an investigational clinical study or experimental drug treatment within 30 days prior to study inclusion or within a period of 5 half-lives of the substances administered in the investigational clinical study or during an experimental drug treatment prior to inclusion in the study, depending on which period is longest
- Known hypersensitivity or allergic reaction to any of the following substances: 5-fluorouracil, folinic acid, panitumumab, irinotecan, and chemically related substances and/or hypersensitivity to any of the excipients of any of the aforementioned substances including known hypersensitivity reactions to monoclonal antibodies NCI CTCAE Grade ≥ 3.
- Known hypersensitivity to Chinese hamster ovary cell (CHO) - cellular products or other recombinant human or humanised monoclonal antibodies
- History of uncontrolled bronchial asthma
- Patients with interstitial pneumonitis or pulmonary fibrosis
- Patients with known brain metastasis
- History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea
- Symptomatic peritoneal carcinomatosis
- Severe, non-healing wounds, ulcers or bone fractures
- Patients with acute or chronic infection requiring systemic therapy
- Known history of positive testing for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- Active or chronic Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive; serologic tests required in patients who receive study treatment).
- Known DPD deficiency (specific screening not required)
- Known glucuronidation deficiency (Gilbert's syndrome);(specific screening not required
- Treatment with sorivudine or brivudine within 28 days before study enrollment or requirement for concomitant antiviral treatment with sorivudine or brivudine
- History of a second primary malignancy during the past 5 years before inclusion in the study or during participation in the study, with the exception of a basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ, if these were treated curatively.
- Known previous or ongoing alcohol or drug abuse
- Pregnant or breast-feeding patients
- Any other severe concomitant disease or disorder which, in the investigator's opinion, could influence the patient's ability to participate in the study or influence his/her safety during the study or interfere with interpretation of study results
- Both, absent and restricted legal capacity
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04034173
Start Date
August 1 2019
End Date
August 1 2026
Last Update
July 26 2019
Active Locations (1)
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1
Ludwigs Maximialians University
Munich, Germany, 81377