Patients with actionable target identified in metastatic cancer for palliative systemic treatment. MedDRA version: 16.1 Level: PT Classification code 10053548 Term: Gastrointestinal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.1 Level: PT Classification code 10050017 Term: Lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA ver
Conditions
Interventions
Trade Name: Vectibix (Panitumumab)
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Erbitux (Cetuximab)
Pharmaceutical Form: Solution for infusion
Trade Name: Iressa (Gefitini
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclution in this study have to meet all of the following cititeria: a. Metastatic cancer and progression by RECIST (verified by study radiologist) on at least one prior regimen of established palliative systemic therapies for advanced disease and eligibility for repeat biopsy sampling. The patient must have received =6 weeks of the previous treatment b. The last radiological evaluation interval in period A must have been within 6 to 10 weeks. c. Age = 18 years. d. Eastern Cooperative Oncology Group (ECOG) performance status 1 or lower. e.Life expectancy of more than 3 months. f. Adequate bone marrow function without current use of colony-stimulating factors: Neutrophils =1.5 x109/l; Platelets =100 x109/l; Hb >10 g/dl, INR within normal level. g. Adequate liver function: AST/ALT 30 g/l. h. Adequate renal function: Creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Drug-specific exclusion criteria may exist and will be specified in the relevant drug specific protocol. Additionally, patients will be excluded from the study if they meet any of the following criteria: a. Metastatic disease from more than one malignancy. b. Untreated or symptomatic brain metastasis (patients must be symptom-free without the use of corticosteroids). c. Any reason why, in the opinion of the investigator, the patient should not participate. d. Pregnancy. e. Anticoagulation with coumarine derivatives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Metastatic tumors harboring actionable molecular targets or signaling pathways may respond to inhibitory agents directed against the specific aberrations irrespective of tumor origin. ;Secondary Objective: Feasibility of ATI-based therapy (personalized cancer treatment).;Primary end point(s): The Primary Endpoint is to compare the PFS using therapy selected by ATI (Actionable Tumor Identification) in a patient’s tumor (period B) with the PFS for the most recent therapy on which the patient had just experienced progression (period A). If the PFS of period B/PFS of period A ratio is =1.3, the ATI-selected therapy is defined as having benefit for the patient.;Timepoint(s) of evaluation of this end point: Tumor response and PFS will be evaluated by regular physical examination and CT/MR-scan every 8 week during treatment period and at the 3 month FU visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall survival (OS) - Overall response rate (Partial response [PR] + complete response [CR]) according to RECIST 1.0;Timepoint(s) of evaluation of this end point: Survival data will be collected from time of study treatment start. Date of death will be obtained by written information. | — |
Countries
Norway
Contacts
Public ContactKjersti Flatmark
Oslo University Hospital, Institute for Cancer Research, Department of Tumor Biology
Outcome results
None listed