Unresectable or metastatic pancreatic cancer MedDRA version: 9.1 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic MedDRA version: 9.1 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable
Conditions
Sponsors
Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection. Radiologically measurable disease is not required. Patients with documented invasion of adjacent organs (eg, colon, duodenum, stomach) by MRI/CT scan are not eligible. 2. Adequate hepatic and renal function documented within 14 days prior to treatment as documented by: - AST and ALT =2.5 x upper limit of normal (ULN), unless there are liver metastases in which case AST and ALT =5.0 x ULN - Total bilirubin =1.0 x ULN - Serum creatinine =1.5 x ULN or calculated creatinine clearance =60 mL/min - Urinary protein =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior treatment with any systemic chemotherapy for metastatic disease. 2. Prior adjuvant chemotherapy or radiotherapy ½ tsp of bright red blood per day within past 1 week. 7. Gastrointestinal abnormalities including: - inability to take oral medication - requirement for intravenous alimentation - prior surgical procedures affecting absorption including gastric resection - treatment for active peptic ulcer disease in the past 6 months - active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy - malabsorption syndromes 8. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, clarithromycin, ergot derivatives, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, and delavirdine). 9. Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, primidone, rifabutin, rifampin, and St. John’s wort). Patients who need to be on anticoagulant therapy during treatment should be treated with low molecular weight heparin as the preferred therapy. The administration of coumadin may be allowed; however, due to possibility of inhibition of CYP1A2-mediated metabolism of coumadin by AG-013736, appropriate monitoring of prothrombin time/international normalized ratio (PT/INR) should be performed for any potential increased coumadin effect. 10. Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis. 11. A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment. 12. Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, deep vein thrombosis or pulmonary embolism. 13. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. 14. History of a malignancy (other than pancreatic cancer) except those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years 15. Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks of treatment. (Also
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Compare the Overall Survival (OS) of patients receiving gemcitabine plus AG-013736 versus gemcitabine plus placebo;Secondary Objective: - Compare the Progression Free Sursvival (PFS) of patients in each arm - Compare the Objective Response Rate (ORR) of patients in each arm - Estimate the Duration of Objective Response (DR) of patients in each arm - Evaluate the safety and tolerability of AG-013736 plus gemcitabine - Compare the health related quality of life (HRQOL), pain ratings, and health status of patients in each arm as measured by the European Organization for the Research and Treatment of Cancer, EORTC QLQ-C30, PAN26, BPI-sf, and EQ-5D - Conduct population pharmacokinetic analysis using AG-013736 plasma concentrations;Primary end point(s): Primary endpoint: Overall Survival Seondary endpoints: 1. Progression Free Survival 2. Objective Response Rate 3. Duration of Objective Response 4. Type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Version 3.0), timing, seriousness, and relatedness of adverse events, and laboratory abnormalities 5. Patient Reported Ooutcomes: EORTC QLQ C30, QLQ PAN26, BPI sf, EQ 5D 6. AG-013736 population pharmacokinetic analysis | — |
Countries
Austria, Belgium, Czech Republic, France, Germany, Hungary, Ireland, Italy, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed