Clareo Health | Maintenance Therapy With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction and Re-induction After Progress for 1st-line Treatment of Metastatic Colorectal Cancer
Maintenance Therapy With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction and Re-induction After Progress for 1st-line Treatment of Metastatic Colorectal Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AIO-Studien-gGmbH
With
ClinAssess GmbH
Amgen
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed written informed consent
Male or female ≥ 18 years of age
Histologically proven metastatic colorectal cancer
Molecular testing showing RAS wild-type in colorectal carcinoma cells
Life expectancy \> 12 weeks
At least one measurable lesion according to RECIST 1.1
Adequate bone marrow, liver, kidney, organ and metabolic function
Bone marrow function:
* leukocyte count ≥ 3.0 × 109/L
* ANC ≥ 1.5 × 109/L
* platelet count ≥ 100 × 109/L
* hemoglobin ≥ 9 g/dL or 5.59 mmol/L (may be transfused or treated with erythropoietin to maintain/ exceed this level)
Hepatic function:
* Total bilirubin ≤ 1.5 × UNL
* ALT and AST ≤ 2.5 × UNL (or ≤ 5 × UNL in presence of liver metastases)
* AP ≤ 5 × UNL
Renal function:
* Creatinine clearance ≥ 50 mL/min according to Cockcroft-Gault formula or serum creatinine ≤ 1.5 × UNL
Metabolic function:
* Magnesium ≥ lower limit of normal
* Calcium ≥ lower limit of normal
ECOG performance status 0 - 1
Women of child-bearing potential must have a negative pregnancy test
You may not be if
Previous treatment for colorectal cancer in the metastatic setting
Previous EGFR-targeting therapy \< 6 months after end of adjuvant therapy
Known brain metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids
Chronic inflammatory bowel disease
Peripheral neuropathy ≥ NCI-CTCAE V 4.03 grade 2
Other previous malignancies with the exception of a history of previous curatively treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix or other curatively treated malignant disease without recurrence after at least 5 years of follow-up
Significant disease that, in the investigator's opinion, would exclude the patient from the study
History of cardiac disease; defined as:
* Congestive heart failure \> New York Heart Association (NYHA) class 2
* Active coronary artery disease (myocardial infarction more than 6 months prior to start of study treatment is allowed)
* Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted)
* Uncontrolled hypertension (defined as blood pressure ≥ 160 mmHg systolic and/or ≥ 90 mmHg diastolic on medication)
Patients with interstitial lung disease, e.g., pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
Known HIV, hepatitis B or C infection
Known hypersensitivity reaction to any of the study components
Radiotherapy, major surgery or any investigational drug 30 days before registration
Pregnancy or lactation or planning to be pregnant during treatment and within 6 months after the end of treatment
Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for at least an additional 6 months after the end of treatment
Known alcohol or drug abuse
Any condition that is unstable or could jeopardize the safety of the patient and his compliance in the study
