Last updated on March 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Metastatic Colorectal Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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