Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

1. Compare the 1-year survival rate in patients with locally advanced pancreatic cancer treated with paclitaxel, gemcitabine, and radiotherapy with or without tipifarnib.
2. Determine the toxicity and loco-regional activity of this chemoradiotherapy regimen in these patients.
3. Determine the feasibility and toxicity of prolonged administration of tipifarnib after chemoradiotherapy in these patients.
4. Determine whether tipifarnib administered after chemoradiotherapy can increase progression-free and overall survival in these patients.

Entry Criteria

Disease Characteristics:

• 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)

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy (including gemcitabine or paclitaxel) for pancreatic cancer
• No other concurrent cytotoxic agents

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• No prior radiotherapy to the planned field
• No other concurrent radiotherapy

Surgery:

• See Disease Characteristics

Other:

• No other concurrent investigational agents

Patient Characteristics:

Age:

• Not specified

Performance status:

• Zubrod 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,800/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• ALT less than 3 times upper limit of normal
• Bilirubin less than 2.0 mg/dL

Renal:

• Creatinine less than 3.0 mg/dL

Other:

• 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

Expected Enrollment

A total of 154 patients (77 per treatment arm) will be accrued for this study within approximately 20 months.

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.

Rich TA, Myerson RJ, Harris J, et al.: A randomized phase II trial of weekly gemcitabine (G), paclitaxel (P), and external irradiation followed by the farnesyl transferase inhibitor R115777 (NSC#702818) for locally advanced pancreatic cancer (RTOG 0020). [Abstract] American Society of Clinical Oncology 2006 Gastrointestinal Cancers Symposium, 26-28 January 2006, San Francisco, California. A-121, 2006.

Garofalo MC, Winter K, Regine WF, et al.: Recursive partitioning analysis (RPA) of prognostic factors in six Radiation Therapy Oncology Group (RTOG) trials of chemoradiotherapy for unresectable pancreatic cancer. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-144, S80-1, 2006.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Tyvin Rich, MD, Protocol chair		Ph: 808-924-5564; 800-223-9173

Registry Information
Official Title		A Randomized Phase II Trial Of Weekly Gemcitabine, Paclitaxel And External Irradiation (50.4GY) Followed By The Farnesyl Transferase Inhibitor R115777 (NSC # 702818) For Locally Advanced Pancreatic Cancer
Trial Start Date		2001-11-08
Trial Completion Date		2010-03-31
Registered in ClinicalTrials.gov		NCT00026104
Date Submitted to PDQ		2001-08-30
Information Last Verified		2003-09-30
NCI Grant/Contract Number		CA21661

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