Clinical trial NCT00475293 (phase 2, status: completed)
Conditions: metastatic colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: panitumumab and cpt-11
SMILES: CCC1=C2CN3C(=CC4=C(COC(=O)[C@]4(O)CC)C3=O)C2=NC2=CC=C(OC(=O)N3CCC(CC3)N3CCCCC3)C=C12
Eligibility criteria:

        Inclusion Criteria:

          -  Man or woman > 18 years of age

          -  Competent to comprehend, sign, and date an IEC-approved informed consent form

          -  Histologically or cytologically-confirmed metastatic adenocarcinoma of the colon or
             rectum.

          -  Radiographically documented disease progression per modified RECIST criteria either
             while receiving or ≤ 6 months after the last dose of prior first-line chemotherapy for
             mCRC

          -  At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST
             criteria.

          -  If subject has prior history of cancer other than colorectal carcinoma, basal cell
             carcinoma, or cervical carcinoma in situ, then subject must not have had treatment or
             active disease within 5 years.

          -  Prior radiotherapy is acceptable.

          -  One and only one prior chemotherapy regimen for mCRC consisting of first-line
             fluoropyrimidine-based chemotherapy.

          -  ECOG performance status of 0, 1 or 2

          -  Life expectancy ≥ 3 months

          -  Hematologic function:ANC > 1.5 x 109/L, Platelet count > 100 x 109/L, Hemoglobin > 10
             g/dL

          -  Renal function: Creatinine < 1.5 mg/dL

          -  Hepatic function: AST and ALT < 3 x ULN (if liver metastases < 5 x ULN)

          -  Bilirubin < 2 x ULN

        Exclusion Criteria:

          -  No more than one prior chemotherapy regimen for mCRC consisting of first-line
             fluoropyrimidine-based chemotherapy. (Prior adjuvant fluoropyrimidine-based
             chemotherapy is allowed)

          -  Prior systemic therapy for the treatment of metastatic colorectal carcinoma with the
             exception of adjuvant fluoropyrimidine-based chemotherapy given at least 6 months
             prior to enrolment.

          -  Systemic chemotherapy, hormonal therapy, immunotherapy or experimental or approved
             proteins/antibodies (eg, bevacizumab) ≤ 30 days before inclusion

          -  Unresolved toxicities from prior systemic therapy that, in the opinion of the
             investigator, does not qualify the patient for inclusion

          -  Central nervous system/brain metastases

          -  Significant cardiovascular disease including unstable angina or myocardial infarction
             within 6 months before initiating study treatment or a history of ventricular
             arrhythmia

          -  Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment small molecule EGFr
             tyrosine kinase inhibitors (eg, erlotinib)

          -  History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial
             pneumonitis or pulmonary fibrosis on baseline chest CT scan

          -  Treatment for systemic infection within 14 days before initiating study treatment

          -  Radiotherapy ≤ 14 days prior to inclusion. Patients must have recovered from all
             radiotherapy-related toxicities

          -  Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea
             (defined as > 4 loose stools per day)

          -  History of Gilbert's syndrome or dihydropyrimidine deficiency

          -  History of any medical condition that may increase the risks associated with study
             participation or may interfere with the interpretation of the study results

          -  Known positive test for human immunodeficiency virus infection, hepatitis C virus,
             chronic active hepatitis B infection

          -  subject allergic to the ingredients of the study medication or to Staphylococcus
             protein A

          -  Any co-morbid disease that would increase risk of toxicity

          -  Any kind of disorder that compromises the ability of the subject to give written
             informed consent and/or comply with the study procedures

          -  Any investigational agent within 30 days before enrolment

          -  Must not have had a major surgical procedure within 28 days of randomization

          -  Subject who is pregnant or breast feeding

          -  Woman or man of childbearing potential not consenting to use adequate contraceptive
             precautions i.e. double barrier contraceptive methods

          -  Subject unwilling or unable to comply with study requirements