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

NCT ID: NCT00026104

Last Updated: 2020-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-30

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.

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.

Conditions

Adenocarcinoma of the Pancreas; Stage II Pancreatic Cancer; Stage III Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

gemcitabine hydrochloride

Intervention Type: DRUG

Given IV

paclitaxel

Intervention Type: DRUG

Given IV

radiation therapy

Intervention Type: RADIATION

Undergo radiation therapy

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.

Group Type: EXPERIMENTAL

tipifarnib

Intervention Type: DRUG

Given orally

radiation therapy

Intervention Type: RADIATION

Undergo radiation therapy

Interventions

gemcitabine hydrochloride

Given IV

Intervention Type: DRUG

paclitaxel

Given IV

Intervention Type: DRUG

tipifarnib

Given orally

Intervention Type: DRUG

radiation therapy

Undergo radiation therapy

Intervention Type: RADIATION

Other Intervention Names

dFdC; difluorodeoxycytidine hydrochloride; gemcitabine; Gemzar; Anzatax; Asotax; TAX; Taxol; R115777; Zarnestra; irradiation; radiotherapy; therapy, radiation

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NRG Oncology

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tyvin Rich

Role: PRINCIPAL_INVESTIGATOR

Radiation Therapy Oncology Group

Locations

Radiation Therapy Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

RTOG-PA-0020

Identifier Type: -

Identifier Source: secondary_id

CDR0000068986

Identifier Type: -

Identifier Source: secondary_id

U10CA021661

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-02423

Identifier Type: -

Identifier Source: org_study_id