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RATIONALE: Monoclonal antibodies, such as ganitumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as gemcitabine hydrochloride and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy, such as 3-dimensional conformal radiation therapy, that delivers a high-dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of ganitumab when given together with gemcitabine hydrochloride followed by radiation therapy, ganitumab, capecitabine, and maintenance therapy in treating patients with locally advanced cancer of the pancreas.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of ganitumab followed by an expanded cohort study.
Induction therapy: Patients receive ganitumab IV over 1-2 hours on days 1 and 15 and gemcitabine hydrochloride IV over 30 minutes on days 1, 15, and 22. Treatment repeats every 28 days for 2 courses.
Concurrent therapy: Beginning 10-28 days later, patients undergo 3-dimensional conformal radiotherapy once daily, 5 days a week for 5.5 weeks beginning on day 1. Patients also receive concurrent ganitumab IV over 1-2 hours on days 1, 15, and 29 and capecitabine orally (PO) twice daily on days 1-5 weekly for 5.5 weeks.
Maintenance therapy: Beginning 21-42 days later, patients receive ganitumab IV over 1-2 hours on days 1 and 15 and gemcitabine hydrochloride IV over 30 minutes on days 1, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 2 years, every 4 months for 1 year, and then annually thereafter.
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Pathologically confirmed (histologic or cytologic) locally advanced adenocarcinoma of the pancreas
Patients with or without regional adenopathy are eligible
No distant metastases based upon the following minimum diagnostic workup:
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
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
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
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
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:
Primary purpose
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8 participants in 6 patient groups
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Data sourced from clinicaltrials.gov
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