Sunitinib in Treating Patients With Metastatic Pancreatic Cancer That Progressed After First-Line Therapy With Gemcitabine

Completed · Phase 2

Conditions studied: Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer

In brief

This phase II trial is studying how well sunitinib works in treating patients with metastatic pancreatic cancer that progressed after first-line therapy with gemcitabine. Sunitinib may stop the growth of pancreatic cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT00397787

Run by

National Cancer Institute (NCI)

People needed

64

Starts

2006-11-01

Last updated by the study team

2013-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic or cytologic documentation of pancreatic adenocarcinoma with evidence of disease progression following first-line therapy is required
• No brain metastases
• Patients with measurable disease
• Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded as >= 20 mm with conventional techniques or as>= 10 mm with spiral computed tomography (CT) scan; of particular note, the primary pancreatic tumor does not constitute measurable disease; therefore, patients with locally advanced pancreatic cancer as the sole site of disease are not eligible
• Patients must have received one of the following prior therapies containing gemcitabine:
• One and only one prior therapy for metastatic disease with gemcitabine, or a gemcitabine-containing cytotoxic combination, or
• One prior chemoradiation therapy containing gemcitabine for inoperable locally advanced pancreatic cancer, as long as the patient has subsequently progressed and has measurable disease outside a radiation port, or
• One prior adjuvant chemotherapy regimen or chemoradiation therapy containing gemcitabine if the patient subsequently progressed within 3 months of completion of adjuvant therapy; patients who have received chemoradiation in the adjuvant setting must have measurable disease outside the radiation port
• No prior therapy with any other antiangiogenic agent (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, PTK787, VEGF Trap, etc.)
• At least 4 weeks must have elapsed prior to initiation of treatment since the completion of chemotherapy and/or radiation therapy
• At least 4 weeks must have elapsed prior to registration since any major surgery
• Prior erlotinib is permitted; the last dose must have been administered 14 or more days prior to initiation of treatment; all erlotinib related side effects must have resolved to < grade 1 prior to registration
• No significant cardiac disease including:
• QTc prolongation (defined as a QTc interval equal to or greater than 500 msec) or other significant EKG abnormalities
• History of myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within 12 months prior to registration
• History of class III or IV heart failure within 12 months prior to registration as defined by the NYHA functional classification system
• In addition, patients with history of hypertension must be well controlled (< 140/90) on a regimen of anti-hypertensive therapy
• Patients with a history of hypothyroidism are eligible, provided they are currently euthyroid
• The use of inhibitors and inducers of CYP3A4 is not permitted:
• The following inhibitors of CYP3A4 is prohibited within 7 days before beginning and during treatment with sunitinib:
• Azole antifungals (ketoconazole, itraconazole)
• Diltiazem
• Clarithromycin
• Erythromycin
• Verapamil

Where it is running

• Cancer and Leukemia Group B — Chicago, Illinois, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.