Flavopiridol Plus Radiation Therapy Followed By Gemcitabine Hydrochloride in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer

Completed · Phase 1

Conditions studied: Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer

In brief

Drugs used in chemotherapy work different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Flavopiridol may make the tumor cells more sensitive to radiation therapy. Phase I trial to study the effectiveness of combining flavopiridol with radiation therapy followed by gemcitabine hydrochloride in treating patients who have locally advanced, unresectable pancreatic cancer.

Key facts

Study ID

NCT00047307

Run by

National Cancer Institute (NCI)

People needed

46

Starts

2002-08-01

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…

• Histologically or cytologically confirmed adenocarcinoma of the pancreas
• No non-adenocarcinoma of the pancreas (i.e., islet cell, lymphoma, or sarcoma)
• Locally advanced and unresectable disease defined as the following:
• Obvious encasement of the celiac, hepatic, or superior mesenteric artery
• Encasement of the portal or superior mesenteric vein not amenable to resection
• Extrapancreatic extension with or without regional lymph node involvement
• No distant metastases
• Measurable or evaluable disease
• Primary pancreatic tumor is considered evaluable, not measurable
• A lymph node mass is considered measurable
• Performance status - ECOG 0-2
• Performance status - Karnofsky 60-100%
• More than 12 weeks
• WBC at least 3,000/mm\^3
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Bilirubin no greater than 1.5 mg/dL
• AST and ALT no greater than 2.5 times upper limit of normal
• Creatinine no greater than 1.5 mg/dL
• Creatinine clearance at least 60 mL/min
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• No Crohn's disease or inflammatory bowel disease that would preclude study participation
• No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation

Where it is running

• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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