Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
92

Inclusion Criteria

Cohort I: Histologically confirmed and definitively inoperable or irresectable metastatic colorectal cancer. Focus on patients with large tumor load at metastatic sites and/or symptomatic metastatic disease
Cohort II: Chance of secondary resection with curative intent defined and reviewed by expert panel
KRAS exon 4 (codons 117/146)
...
Cohort I: Histologically confirmed and definitively inoperable or irresectable metastatic colorectal cancer. Focus on patients with large tumor load at metastatic sites and/or symptomatic metastatic disease
Cohort II: Chance of secondary resection with curative intent defined and reviewed by expert panel
KRAS exon 4 (codons 117/146)
NRAS exon 4 (codons 117/146) assessed by an institution participating in and certified by the specific working group of the Deutsche Gesellschaft für Pathologie)
Male and female subjects > 18 years of age
Adult patients (≥ 18 years of age)
Performance status ECOG 0-1
At least one measurable lesion according to RECIST measured within 3 weeks prior to registration
NRAS exon 3 (codons 59/61)
Adequate haematological, hepatic, renal and metabolic function parameters:
NRAS exon 2 (codons 12/13)
KRAS exon 3 (codons 59/61)
KRAS exon 2 (codons 12/13)
No previous chemotherapy for metastatic disease (adjuvant chemotherapy for non-metastatic disease is allowed if terminated more than 6 months ago)

Exclusion Criteria

Allogeneic transplantation requiring immunosuppressive therapy.
Current or recent (within the 28 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
Subjects with known allergy to the study drugs or to any of its excipients.
...
Allogeneic transplantation requiring immunosuppressive therapy.
Current or recent (within the 28 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
Subjects with known allergy to the study drugs or to any of its excipients.
Pre-existing neuropathy > grade 1 (NCI CTCAE), except for loss of tendon reflex
Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 6 months before enrolment.
Other malignant disease without recurrence after at least 5 years of follow-up
Evidence of bleeding diathesis or coagulopathy.
Major surgical procedure, open biopsy, nor significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study except for surgery for colorectal cancer with curative intent and central venous line placement for chemotherapy administration.
Concomitant therapy with certain anti-viral medicines (sorivudine and brivudine or analogue compounds).
History of evidence upon physical examination of CNS disease unless adequately treated (e.g. primary brain tumour, seizure not controlled with standard medical therapy, brain metastases or history of stroke).
Known grade III/IV allergic reaction against monoclonal antibodies.
Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial.
Past or current history of malignancies except for the indication under this study and curatively treated:
Pregnancy or breastfeeding women.
Patients not receiving therapeutic anticoagulation must have an INR < 1,5 ULN and aPTT < 1,5 ULN within 7 days prior to randomization. The use of full dose anticoagulants is allowed as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least two weeks at the time of randomisation.
Severe non-healing wounds, ulcers or bone fractions.
Clinically relevant interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
Basal and squamous cell carcinoma of the skin
Known DPD deficiency.
In-situ carcinoma of the cervix

Summary

Conditions
Metastatic Colorectal Cancer
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criteria

Cohort I: Histologically confirmed and definitively inoperable or irresectable metastatic colorectal cancer. Focus on patients with large tumor load at metastatic sites and/or symptomatic metastatic disease
Cohort II: Chance of secondary resection with curative intent defined and reviewed by expert panel
KRAS exon 4 (codons 117/146)
...
Cohort I: Histologically confirmed and definitively inoperable or irresectable metastatic colorectal cancer. Focus on patients with large tumor load at metastatic sites and/or symptomatic metastatic disease
Cohort II: Chance of secondary resection with curative intent defined and reviewed by expert panel
KRAS exon 4 (codons 117/146)
NRAS exon 4 (codons 117/146) assessed by an institution participating in and certified by the specific working group of the Deutsche Gesellschaft für Pathologie)
Male and female subjects > 18 years of age
Adult patients (≥ 18 years of age)
Performance status ECOG 0-1
At least one measurable lesion according to RECIST measured within 3 weeks prior to registration
NRAS exon 3 (codons 59/61)
Adequate haematological, hepatic, renal and metabolic function parameters:
NRAS exon 2 (codons 12/13)
KRAS exon 3 (codons 59/61)
KRAS exon 2 (codons 12/13)
No previous chemotherapy for metastatic disease (adjuvant chemotherapy for non-metastatic disease is allowed if terminated more than 6 months ago)

Exclusion Criteria

Allogeneic transplantation requiring immunosuppressive therapy.
Current or recent (within the 28 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
Subjects with known allergy to the study drugs or to any of its excipients.
...
Allogeneic transplantation requiring immunosuppressive therapy.
Current or recent (within the 28 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
Subjects with known allergy to the study drugs or to any of its excipients.
Pre-existing neuropathy > grade 1 (NCI CTCAE), except for loss of tendon reflex
Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 6 months before enrolment.
Other malignant disease without recurrence after at least 5 years of follow-up
Evidence of bleeding diathesis or coagulopathy.
Major surgical procedure, open biopsy, nor significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study except for surgery for colorectal cancer with curative intent and central venous line placement for chemotherapy administration.
Concomitant therapy with certain anti-viral medicines (sorivudine and brivudine or analogue compounds).
History of evidence upon physical examination of CNS disease unless adequately treated (e.g. primary brain tumour, seizure not controlled with standard medical therapy, brain metastases or history of stroke).
Known grade III/IV allergic reaction against monoclonal antibodies.
Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial.
Past or current history of malignancies except for the indication under this study and curatively treated:
Pregnancy or breastfeeding women.
Patients not receiving therapeutic anticoagulation must have an INR < 1,5 ULN and aPTT < 1,5 ULN within 7 days prior to randomization. The use of full dose anticoagulants is allowed as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least two weeks at the time of randomisation.
Severe non-healing wounds, ulcers or bone fractions.
Clinically relevant interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
Basal and squamous cell carcinoma of the skin
Known DPD deficiency.
In-situ carcinoma of the cervix

Tracking Information

NCT #
NCT01328171
Collaborators
  • Amgen
  • ClinAssess GmbH
Investigators
  • Principal Investigator: Michael Geißler, MD, PhD Department of Oncology and Gastroenterology, Academic Teaching Hospital Esslingen
  • Michael Geißler, MD, PhD Department of Oncology and Gastroenterology, Academic Teaching Hospital Esslingen
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