Ganitumab and Gemcitabine Hydrochloride Followed by Radiation Therapy, Ganitumab, Capecitabine, and Maintenance Therapy in Treating Patients With Locally Advanced Cancer of the Pancreas
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage IIB pancreatic cancer, stage III pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Pathologically confirmed (histologic or cytologic) locally advanced adenocarcinoma of the pancreas
- Patients must have unresectable disease based on institutional standardized criteria of unresectability or medical inoperability
- Patients with or without regional adenopathy are eligible
No distant metastases based upon the following minimum diagnostic workup:
- History and/or physical examination, including collection of weight and vital signs, within 28 days prior to study entry
- Abdominal and/or pelvic CT scan with IV contrast or MRI scan within 21 days prior to study entry
- Chest CT scan or whole-body PET/CT within 21 days prior to study entry
- No second malignancy or peritoneal seeding
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- Absolute neutrophil count (ANC) ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin (Hgb) ≥ 10.0 g/dL (the use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dL is acceptable)
- Glycosylated hemoglobin (HgbA1c) ≤ 8%
- Serum creatinine ≤ 1.5 mg/dL
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 3 times upper limit of normal (ULN)
- Total bilirubin < 3.0 mg/dL
- Alkaline phosphatase < 3 times ULN
Fasting blood glucose < 160 mg/dL
- Patients with a non-fasting blood glucose > 160 mg/dL (8.9 mmol/L) must have a fasting blood glucose ≤ 160 mg/dL (8.9 mmol/L) in order to be eligible
- No grade 2 or worse hearing impairment
- Negative serum pregnancy test (if applicable)
- Women of childbearing potential and men who are sexually active must be willing/able to use medically acceptable forms of contraception during the course of the study, and for 3 months (6 months for men) after the last study drug administration
- Not pregnant or nursing
- Ability to swallow oral medications
- At least 3 years since prior malignancy except non-melanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
No severe active co-morbidity, defined as any of the following:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within 6 months prior to study entry
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization, or precluding study therapy within 30 days before registration
- Uncontrolled malabsorption syndrome significantly affecting gastrointestinal function
- Any unresolved bowel or bile duct obstruction
- Major resection of the stomach or small bowel that could affect the absorption of capecitabine
Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition
- HIV testing is not required for entry into this protocol
- Existing venous thromboembolism requiring anti-coagulation therapy
- No prior allergic reaction to capecitabine or gemcitabine hydrochloride
PRIOR CONCURRENT THERAPY:
No prior systemic chemotherapy for pancreatic cancer
- Prior chemotherapy for malignancies other than pancreatic cancer is allowed provided chemotherapy was completed > 3 years prior to study entry
- No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
More than 28 days since any prior major surgery
- Insertion of a vascular access device, insertion of a biliary stent, exploratory laparotomy, or laparoscopy are not considered major surgery
- No prior ganitumab
- Patients requiring concurrent oral anticoagulants (e.g., Coumadin, warfarin) are eligible provided there is increased vigilance with respect to monitoring international normalized ratio (INR)
- No concurrent participation in another clinical treatment trial
- No concurrent intensity-modulated radiotherapy
No other concurrent therapy including the following:
- Other investigational or approved chemotherapeutic agents
- Other monoclonal antibody
- Sorivudine or brivudine A
- Cimetidine
- G-CSF agents
Sites / Locations
- St. Joseph Hospital Regional Cancer Center - Orange
- CCOP - Christiana Care Health Services
- James Graham Brown Cancer Center at University of Louisville
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Summa Center for Cancer Care at Akron City Hospital
- McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
- Rhode Island Hospital Comprehensive Cancer Center
- Northmain Radiation Oncology
- M. D. Anderson Cancer Center at University of Texas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm A
Arm B
Arm C
Arm D
Arm E
Arm F
Dose level -1A (Ganitumab 6 mg/kg, Capecitabine 825mg/m2)
Dose level 1A (Ganitumab 12 mg/kg, Capecitabine 825mg/m2)
Dose level 2A (Ganitumab 20 mg/kg, Capecitabine 825mg/m2)
Dose level -1B (Ganitumab 6 mg/kg, Capecitabine 625mg/m2)
Dose level 1B (Ganitumab 12 mg/kg, Capecitabine 625mg/m2)
Dose level 2B (Ganitumab 20 mg/kg, Capecitabine 625mg/m2)