None listed
Conditions
Interventions
This group will receive: Gemeitabine in a dose of 1000 mg / m2 for 30 minutes on days 1, 8, 15, 22, 29, 36, 43 of a cycle of 8 weeks and beginning on day 57, on days 1, 8 and 15 of the consecutive 4-week cycles. Bevacizumab at a dose of 5 mg / kg on days 1, 15, 29 and 43 of cycle 1, and then beginning on day 57, on days 1 and 15 of each consecutive 4-week cycle. Erlotinib in a daily dose of 100 mg at least one hour before or two hours after the ingestion of food.
Group name:ARM 2 Type of gro
This group will receive: Gemeitabine in a dose of 1000 mg / m2 for 30 minutes on days 1, 8, 15, 22, 29, 36, 43 of a cycle of 8 weeks and beginning on day 57, on days 1, 8 and 15 of the consecutive 4-week cycles. Bevacizumab PLACEBO on days 1, 15, 29 and 43 of cycle 1, and then starting on day 57, on days 1 and 15 of each consecutive 4-week cycle. Erlotinib in a daily dose of 100 mg at least one hour before or two hours after the ingestion of food.
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age> 18 years. 2. Able to comply with the protocol. 3. Kamofsky Performance Status> 60%. 4. Life expectancy of> 8 weeks. 5. Free and informed consent in writing. 6. Pancreatic cancer (adenocarcinoma) histologically or cytologically documented with metastatic disease (stage IV) measurable or not measurable according to the sixth edition of the TNM classification. 7. Function of proper bone marrow 8. INR <1.5 and aPTT <1.5 x ULN within 7 days prior to randomization. 9. Adequate liver function. 10. Adequate renal function.
Exclusion criteria
Exclusion criteria: 1. Local pancreatic cancer (Stage IA to IIB) and locally advanced pancreatic cancer (stage III). 2. Previous adjuvant radiotherapy for pancreatic cancer. 3. Less than (or equal to) six months from the last adjuvant chemotherapy. 4. Previous systemic therapy for metastatic pancreatic cancer. 5. Another primary tumor (including primary brain tumors) within the last 5 years prior to randomization. 6. Evidence of compression of the spinal column or current evidence of CNS metastasis. 7. History or evidence, in the neurological examination, of other CNS diseases. 8. Evidence based on CT scan of tumor invading main blood vessels. 9. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the start of study treatment. 10. Current or newly used chronic aspirin. 11. Current or recently used chronic full therapeutic dose of oral or parenteral anticoagulants or thrombolytic agents. 12. Uncontrolled hypertension or clinically significant cardiovascular disease. 13. History or evidence of inherited blood diathesis or coagulopathy with the risk of bleeding. 14. Wound not healing, ulcer, or bone fracture, patients with esophageal varices. 15. Any significant known ophthalmological abnormalities of the eye surface. 16. Inability to take medication orally. 17. Pregnant women or breastfeeding. 18. Men and women of maternity potential not using effective means of contraception. 19. Current or newly treated with another investigational drug or participation in another research study. 20. Evidence of any other disease, metabolic dysfunction, result of physical examination or clinical laboratory result giving reasonable suspicion of a disease or condition that contraindicates the use of a research drug or patient at high risk of treatment complications. 21. Known hypersensitivity to any of the study drugs or their ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:1) Global survival. Tumor evaluations. Tumor marker: RECIST criteria: Based on CT scans, MRI, radiography, bone scan and clinical examination. 2) Tumor marker: Serum tumor marker (CA19.9). 3) Clinical benefit response: Based on the evaluation of the analog pain scale VAS 100, the consumption of analgesic therapy (daily pain chart), combined with the evaluation of the Kanofsky Performance Status (KPS) and weight measurements. Measure:Primary efficiency: Global survival. Tumor evaluations. Tumor marker Clinical benefit response (CBR). Timepoints:1) RECIST criteria: During the selection and every 8 weeks until week 40, followed by evaluations every 12 weeks until disease progression is confirmed. 2) CA-19.9: During the selection and every 8 weeks until week 40, followed by evaluations every 12 weeks until disease progression is confirmed. 3) VAS scale and analgesic therapy consumption: Daily throughout the study. 4) KPS and body weight evaluation: Weekly throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) Laboratory tests: Hematological (hemoglobin, hematocrit, platelet count, red blood cell count, white blood cell count with differential, INR, aFIT), biochemistry (Na, K, Ca, Ct, urea, uric acid, total protein , albumin, alkaline phosphatase, ALT, AST, GGT, LDH, direct and total bilirubin, creatinine, CRP), pregnancy test, urinalysis 2) Rod test and / or urine collection for 24 hours in case of> + 2 / + 3 proteinuria. Measure:Primary safety of the treatment Timepoints:1) Blood tests: Weekly until the end of the study 2) Biochemical tests: Every 2 weeks until the end of the study. 3) Rod test and / or urine collection for 24 hours in case of> + 2 / + 3 proteinuria: Prior to each administration of Bevacizumab. ; Outcome name:Demographic characteristics, height, weight and medical history. Measure:Population characteristics Timepoints:1) Demographic characteristics and medical history: At the time of selection. 2) Height and body weight: Weekly throughout the study. ; Outcome name:1) Physical examination and vital signs. 2) ECG. 3) Pulmonary radiography. 4) Brain CT / MRI. 5) Counting of adverse events, intercurrent diseases and concomitant treatments Measure:Secondary treatment safetry Timepoints:1) Physical examination and vital signs: Every 4 weeks. 2) ECG: At the time of selection 3) Pulmonary radiography: At the time of selection. 4) CT / brain MRI: During the selection and every 8 weeks until week 40, followed by evaluations every 12 weeks until disease progression is confirmed. 5) Counting of adverse events, intercurrent diseases and concomitant treatments: Every 4 weeks. ; Outcome name:Evaluation of proteins associated with pancreatic cancer and profiling of the expression of messenger RNA. Measure:Biological markers. Timepoints:Week 9 and when disease progression is confirmed. ; Outcome name:They will be evaluated in a subgroup of patients | — |
Countries
Australia, Austria, Belgium, Canada, China, Czech Republic, Finland, France, Germany, Israel, Italy, Netherlands, New Zealand, Poland, Singapore, South Africa, Spain, Sweden, Taiwan, United Kindgdom
Outcome results
None listed