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

Sponsor:	Radiation Therapy Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00026104

Purpose

RATIONALE: 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.

PURPOSE: 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.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: gemcitabine hydrochloride Drug: paclitaxel Drug: tipifarnib Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Paclitaxel Gemcitabine Gemcitabine hydrochloride R 115777 Tipifarnib

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

November 2001

Detailed Description:

OBJECTIVES:

Compare the 1-year survival rate in patients with locally advanced pancreatic cancer treated with paclitaxel, gemcitabine, and radiotherapy with or without tipifarnib.
Determine the toxicity and loco-regional activity of this chemoradiotherapy regimen in these patients.
Determine the feasibility and toxicity of prolonged administration of tipifarnib after chemoradiotherapy in these patients.
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.

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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

Zubrod 0-1

Life expectancy:

Not specified

Hematopoietic:

Granulocyte count at least 1,800/mm^3
Platelet count at least 100,000/mm^3

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00026104

Show 77 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Tyvin A. Rich, MD

University of Virginia

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000068986, RTOG-PA-0020, RTOG-DEV-1003
Study First Received:	November 9, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00026104 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Neoplasms by Site
Therapeutic Uses
Gemcitabine
Tipifarnib
Endocrine Gland Neoplasms
Digestive System Neoplasms

Mitosis Modulators
Endocrine System Diseases
Enzyme Inhibitors
Antimitotic Agents
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators
Pancreatic Diseases
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 27, 2009