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

Stage III Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00026104
• Other study ID #: NCI-2012-02423
• Secondary ID: RTOG-PA-0020CDR0
• Status: Completed
• Phase: Phase 2
• Start date: November 2001

Study information

• Verified date: October 2020
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma of the Pancreas
• Pancreatic Neoplasms
• Stage II Pancreatic Cancer
• Stage III Pancreatic Cancer

Intervention

Drug:
• gemcitabine hydrochloride
Given IV
• paclitaxel
Given IV
• tipifarnib
Given orally

Radiation:
• radiation therapy
Undergo radiation therapy

Locations

Country	Name	City	State
United States	Radiation Therapy Oncology Group	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)	NRG Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Calculated along with associated 95% confidence intervals.	1 year
Secondary	Frequency of patients developing unacceptable toxicity defined as grade 3 or higher gastrointestinal or pulmonary toxicity and/or discontinuation of treatment	Graded according to the CTCAE version 3.0.	Up to 5 years
Secondary	Difference in overall survival between treatment regimens	Estimated with a 95% confidence interval.	1 year
Secondary	Progression-free survival	Calculated along with associated 95% confidence intervals.	1 year