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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Alvocidib; Gemcitabine

Criteria

Inclusion Criteria:

• 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

• No other uncontrolled concurrent illness that would preclude study participation

• No ongoing or active infection

• No psychiatric illness or social situation that would preclude study participation

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No prior chemotherapy for this disease except gemcitabine hydrochloride-based therapy for which no radiologic evidence of distant metastatic disease exists

• No prior flavopiridol or other cyclin-dependent kinase therapies

• No prior radiotherapy for this disease

• Prior curative surgery with local recurrence allowed

• No other concurrent investigational therapy

• No concurrent combination antiretroviral therapy for HIV-positive patients