NCT00026104

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2001

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

4.8 years

First QC Date

November 9, 2001

Last Update Submit

October 29, 2020

Conditions

Adenocarcinoma of the PancreasStage II Pancreatic CancerStage III Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Calculated along with associated 95% confidence intervals.

    1 year

Secondary Outcomes (3)

  • Frequency of patients developing unacceptable toxicity defined as grade 3 or higher gastrointestinal or pulmonary toxicity and/or discontinuation of treatment

    Up to 5 years

  • Difference in overall survival between treatment regimens

    1 year

  • Progression-free survival

    1 year

Study Arms (2)

Arm I (radiation therapy, paclitaxel, gemcitabine)

EXPERIMENTAL

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 hydrochlorideDrug: paclitaxelRadiation: radiation therapy

Arm II (radiation therapy, tipifarnib)

EXPERIMENTAL

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: tipifarnibRadiation: radiation therapy

Interventions

gemcitabine hydrochlorideDRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Arm I (radiation therapy, paclitaxel, gemcitabine)
paclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol
Arm I (radiation therapy, paclitaxel, gemcitabine)
tipifarnibDRUG

Given orally

Also known as: R115777, Zarnestra
Arm II (radiation therapy, tipifarnib)
radiation therapyRADIATION

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation
Arm I (radiation therapy, paclitaxel, gemcitabine)Arm II (radiation therapy, tipifarnib)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiation Therapy Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GemcitabinePaclitaxelTaxestipifarnibRadiotherapyRadiation

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesEconomicsHealth Care Economics and OrganizationsTherapeuticsPhysical Phenomena

Study Officials

  • Tyvin Rich

    Radiation Therapy Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2001

First Posted

January 27, 2003

Study Start

November 1, 2001

Primary Completion

August 1, 2006

Last Updated

October 30, 2020

Record last verified: 2020-10

Locations

US(1)