Combination Chemotherapy Plus Radiation Therapy With or Without Tipifarnib in Treating Patients With Locally Advanced Pancreatic Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00026104 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : October 30, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adenocarcinoma of the Pancreas Stage II Pancreatic Cancer Stage III Pancreatic Cancer | Drug: gemcitabine hydrochloride Drug: paclitaxel Drug: tipifarnib Radiation: radiation therapy | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 154 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Phase II Trial of Weekly Gemcitabine, Paclitaxel and External Irradiation (50.4 GY) Followed by the Farnesyl Transferase Inhibitor R115777 (NSC #702818) for Locally Advanced Pancreatic Cancer |
Study Start Date : | November 2001 |
Actual Primary Completion Date : | August 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm I (radiation therapy, paclitaxel, gemcitabine)
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.
|
Drug: gemcitabine hydrochloride
Given IV
Other Names:
Drug: paclitaxel Given IV
Other Names:
Radiation: radiation therapy Undergo radiation therapy
Other Names:
|
Experimental: Arm II (radiation therapy, tipifarnib)
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.
|
Drug: tipifarnib
Given orally
Other Names:
Radiation: radiation therapy Undergo radiation therapy
Other Names:
|
- Overall survival [ Time Frame: 1 year ]Calculated along with associated 95% confidence intervals.
- Frequency of patients developing unacceptable toxicity defined as grade 3 or higher gastrointestinal or pulmonary toxicity and/or discontinuation of treatment [ Time Frame: Up to 5 years ]Graded according to the CTCAE version 3.0.
- Difference in overall survival between treatment regimens [ Time Frame: 1 year ]Estimated with a 95% confidence interval.
- Progression-free survival [ Time Frame: 1 year ]Calculated along with associated 95% confidence intervals.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026104
United States, Pennsylvania | |
Radiation Therapy Oncology Group | |
Philadelphia, Pennsylvania, United States, 19103 |
Principal Investigator: | Tyvin Rich | Radiation Therapy Oncology Group |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00026104 |
Other Study ID Numbers: |
NCI-2012-02423 RTOG-PA-0020 CDR0000068986 U10CA021661 ( U.S. NIH Grant/Contract ) |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | October 30, 2020 |
Last Verified: | October 2020 |
Pancreatic Neoplasms Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Paclitaxel Tipifarnib Antineoplastic Agents, Phytogenic Antineoplastic Agents |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |