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

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ClinicalTrials.gov Identifier: NCT00026104
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 6, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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Brief 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.

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

Detailed 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
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • gemcitabine
  • Gemzar

Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol

Radiation: radiation therapy
Undergo radiation therapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
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:
  • R115777
  • Zarnestra

Radiation: radiation therapy
Undergo radiation therapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]
    Calculated along with associated 95% confidence intervals.


Secondary Outcome Measures :
  1. 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.

  2. Difference in overall survival between treatment regimens [ Time Frame: 1 year ]
    Estimated with a 95% confidence interval.

  3. Progression-free survival [ Time Frame: 1 year ]
    Calculated along with associated 95% confidence intervals.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
Radiation Therapy Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Tyvin Rich Radiation Therapy Oncology Group
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00026104     History of Changes
Other Study ID Numbers: NCI-2012-02423
RTOG-PA-0020
RTOG-DEV-1003
CDR0000068986
U10CA021661 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 6, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
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Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Gemcitabine
 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