Combination Chemotherapy Plus Radiation Therapy With or Without Tipifarnib in Treating Patients With Locally Advanced Pancreatic Cancer

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

Summary

Randomized phase II trial to compare the effectiveness of gemcitabine, paclitaxel, and radiation therapy with or without tipifarnib in treating patients who have locally advanced pancreatic cancer. Drugs used in chemotherapy use 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. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy and radiation therapy with tipifarnib may be an effective treatment for pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Collaborator: NRG Oncology
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel; Tipifarnib

Criteria

Inclusion Criteria:

• Histologically confirmed unresectable, locally advanced adenocarcinoma of the pancreas

• Residual disease after resection (R1 or R2, microscopic or macroscopic) allowed

• No metastases in major viscera

• No peritoneal seeding or ascites

• Biliary or gastroduodenal obstruction must have drainage before starting study therapy

• Radiographically assessable disease encompassable within a single irradiation field (15 by 15 cm maximum)

• Performance status - Zubrod 0-1

• Granulocyte count at least 1,800/mm^3

• Platelet count at least 100,000/mm^3

• ALT less than 3 times upper limit of normal

• Bilirubin less than 2.0 mg/dL

• Creatinine less than 3.0 mg/dL

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 2 years except non-melanoma skin cancer or carcinoma in situ of the cervix, uterus, or bladder

• No significant infection or other medical condition that would preclude study

• No prior chemotherapy (including gemcitabine or paclitaxel) for pancreatic cancer

• No other concurrent cytotoxic agents

• See Disease Characteristics

• No prior radiotherapy to the planned field

• No other concurrent radiotherapy

• See Disease Characteristics

• No other concurrent investigational agents