Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

OBJECTIVES: I. Compare the 1-year survival rate in patients with locally advanced pancreatic cancer treated with paclitaxel, gemcitabine, and radiotherapy with or without tipifarnib. II. Determine the toxicity and loco-regional activity of this chemoradiotherapy regimen in these patients. III. Determine the feasibility and toxicity of prolonged administration of tipifarnib after chemoradiotherapy in these patients. IV. Determine whether tipifarnib administered after chemoradiotherapy can increase progression-free and overall survival in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight loss in the preceding 6 months (more than 10% vs 10% or less) and tumor dimension (at least 5 cm vs less than 5 cm). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive radiotherapy once daily, 5 days a week, for 5.5 weeks, beginning on day 1. Patients also receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Arm II: Patients receive chemoradiotherapy as in arm I. Within 3-8 weeks after completion of chemoradiotherapy, patients without disease progression receive oral tipifarnib twice daily for 21 days. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00026104
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date November 2001

See also
  Status Clinical Trial Phase
Completed NCT01959672 - Chemotherapy, Stereotactic Body Radiation Therapy & Nelfinavir Mesylate in Locally Advanced Pancreatic Cancer Phase 2
Terminated NCT02495896 - Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors Phase 1
Terminated NCT02345460 - Preoperative Folfirinox for Resectable Pancreatic Adenocarcinoma - A Phase II Study Phase 2
Completed NCT00095966 - Sorafenib and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Phase 2
Completed NCT00020345 - Combination Chemotherapy and Radiation Therapy Plus Surgery in Treating Patients With Advanced Cancer of the Pancreas Phase 2
Completed NCT02897375 - Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors Phase 1
Completed NCT01846520 - Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers N/A
Completed NCT01191684 - Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer Phase 1
Completed NCT02896907 - Ascorbic Acid and Combination Chemotherapy in Treating Patients With Locally Advanced or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery Early Phase 1
Completed NCT01068327 - Stereotactic Radiation, Nelfinavir Mesylate & Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer Phase 1
Completed NCT02307539 - Palliative Care in Improving Quality of Life in Patients With Newly Diagnosed Pancreatic Cancer N/A
Completed NCT01222689 - Selumetinib and Erlotinib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Phase 2
Completed NCT00028496 - Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer Phase 1
Active, not recruiting NCT03899649 - A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer
Terminated NCT01739439 - Chemoradiation and Radiosurgery Boost in Treating Patients With Locally Advance Pancreatic Cancer That May or May Not be Removed by Surgery Phase 1
Completed NCT01821612 - Chemotherapy and Radiation Therapy Before Surgery Followed by Gemcitabine in Treating Patients With Pancreatic Cancer Early Phase 1
Completed NCT01131234 - Gamma-Secretase Inhibitor RO4929097 and Cediranib Maleate in Treating Patients With Advanced Solid Tumors Phase 1
Recruiting NCT00323583 - Weekly Dosing of an Integrative Chemotherapy Combination to Treat Advanced Pancreatic Cancer Phase 2
Terminated NCT00087191 - EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer N/A
Completed NCT00063947 - Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer Phase 1