colorectal cancer MedDRA version: 20.0 Level: PT Classification code 10009944 Term: Colon cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Zaltrap
Product Name: Zaltrap
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Universitätsklinikum Ulm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histologically confirmed diagnosis of colorectal cancer presenting with unresectable stage IV (UICC) disease (primary tumor may be present) 2. Patients with at least one measurable lesion, with size > 1 cm (RECIST v1.1) 3. ECOG Performance status = 1 4. Life expectancy > 3 months 5. Age =18 years. 6. Haematologic function: ANC = 1.5 x 109/L, platelets = 100 x109/L, hemoglobin = 9 g/dl or 5.59 mmol/l 7. Patients not receiving therapeutic anticoagulation must have an INR =65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
Exclusion criteria: 1. Treatment with any other investigational agent within 30 days prior to entering this study. 2. Prior systemic or local treatment of metastatic disease. 3. Prior adjuvant or neo-adjuvant chemotherapy/radiotherapy completed less than 6 months prior to study entry. 4. Pre History or evidence upon physical/neurological examination of CNS disease (unrelated to cancer) (unless adequately treated with standard medical therapy) e.g. uncontrolled seizures. 5. Fertile women ( 4 loose stools per day) 12. History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) haemoptoe or evidence of interstitial lung disease on baseline chest X-ray or CT scan. 13. Serious, non-healing wound, ulcer or bone fracture. 14. Thrombosis or severe bleeding within 6 months prior to entry into the study (except for bleeding of the tumor before its surgical resection) and no evidence of bleeding diathesis or coagulopathy. 15. Urine dipstick for proteinuria = 2+. If urine dipstick is = 2+, 24-hour urine must demonstrate = 1 g of protein in 24 hours for patient to be eligible. 16. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment. 17. Clinically significant cardiovascular disease, for example CVA, myocardial infarction (= 12 months before treatment start), unstable angina, NYHA Class II CHF, arrhythmia requiring medication, or uncontrolled hypertension. 18. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications. 19. Known hypersensitivity or contraindication to the drugs used in the trial (eg: aflibercept, 5-FU, folinic acid/ leucovorin, oxaliplatin, bevacizumab, irinotecan). 20. Concomitant treatment with ASS > 325 mg or NSAIDs, known to inhibit platelet function, sorivudin or analog compounds or preparations of St. John’s wort. 21. Inability or unwillingness to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluation of the impact of a personalized marker-driven treatment approach with early detection of progression and modification of treatment on cytokines and angiogenetic factors(CAF) and efficacy;Secondary Objective: prognostic and predictive value of CAF at baseline and the changes during treatment, efficacy, tolerability and patient related outcome.;Primary end point(s): Progression free survival (PFS1) of first line treatment The primary endpoint of the randomized part with marker-driven switch of antiangiogenic agent and maintenance of chemotherapy is: Progression free survival rate at 6 months (PFSR@6) after randomization. ;Timepoint(s) of evaluation of this end point: 6 months after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Predictive value of cytokines and angiogenic factor (CAF) for early detection of progression during treatment with chemotherapy and bevacizumab - Determination and validation of a CAF profile predicting tumor progression before radiologic progression - PFS1, after randomization (PFSr) and of second line treatment (PFS2) - Time to randomization (TTR) - Overall survival (OS) - Overall response rate (RR) according to RECIST v1.1 - Secondary resection rate (sRR) - Toxicity (Safety assessments will include physical examinations (blood pressure, heart rate, respiratory rate), vital signs, ECOG, clinical laboratory profile and monitoring of adverse events, according to NCI CTCAE v4.03) - Quality of life using the EORTC QLQ-C30 and the modules CR29 - Changes in CAF during early marker-driven switch and conventional treatment approach - Prognostic value of CAF at baseline and/or during treatment ;Timepoint(s) of evaluation of this end point: 1. After all patients had first progression 2. After completion of run-in phase and after all patients had first progression 3. After all patients had second progression 4. after all patients in randomization part changed treatment 5. at end of study 6. After all patients had second progression 7. at end of study 8. End of study 9. End of treatment 10. after all patients in randomization part changed treatment 11. End of treatment | — |
Countries
Australia, Austria, Germany
Contacts
Public ContactCoordinating Investigator
Universitätsklinikum Ulm
Outcome results
None listed