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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentCompletedNot specifiedNCINCI-2012-02423
RTOG-PA-0020, RTOG-DEV-1003, CDR0000068986, U10CA021661, NCT00026104

Trial Description

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Tyvin RichPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00026104
ClinicalTrials.gov processed this data on October 08, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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