Combination Chemotherapy Plus Radiation Therapy In Treating Patients With Locally Advanced Unresectable Pancreatic Cancer

Study Overview

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.

OBJECTIVES: * Determine the time to progression, local control, and survival of patients with locally advanced, unresectable pancreatic cancer treated with induction gemcitabine and irinotecan followed by gemcitabine and concurrent radiotherapy. OUTLINE: Patients receive induction gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Within 2 weeks of completing induction chemotherapy, patients receive gemcitabine IV over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32. Patients undergo concurrent radiotherapy 5 days a week for 5.5 weeks. Patients are followed every 8 weeks for 6 months and then every 3 months for 1.5 years. PROJECTED ACCRUAL: Approximately 60-120 patients will be accrued for this study within 1-2 years.

Pancreatic Cancer

DRUG: gemcitabine hydrochloride
DRUG: irinotecan hydrochloride
RADIATION: radiation therapy

REBACDR0000068933
CCCWFU-57100
NCI-5332

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2001-10-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-09-07
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-09-09
First Posted (ACTUAL) 2003-01-27	Results First Posted N/A	Last Verified 2021-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically confirmed locally advanced pancreatic cancer
Regional (peri-pancreatic) lymph node involvement allowed
Clinically or surgically staged and considered unresectable or inoperable

18 and over

ECOG 0-2

More than 6 months

Granulocyte count at least 1,500/mm3
Hemoglobin at least 10 g/dL
Platelet count at least 100,000/mm3

Not specified

Creatinine no greater than 2.0 mg/dL

Not pregnant
Fertile patients must use effective contraception
No other concurrent or prior malignancy within the past 2 years except nonmelanoma skin cancer or in situ carcinoma of the cervix or breast
No other serious medical or psychiatric illness that would preclude giving informed consent or limit survival to less than 2 years

No concurrent anticancer immunotherapy

No prior chemotherapy
No other concurrent anticancer chemotherapy

No concurrent anticancer hormonal therapy

No prior abdominal-pelvic radiotherapy
No other concurrent anticancer radiotherapy

See Disease Characteristics
At least 3 weeks since prior open abdominal surgery
More than 10 days since prior laparoscopy

No other concurrent investigational drug
No concurrent participation in other clinical study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Arthur William Blackstock, MD, Wake Forest University Health Sciences

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Mishra G, Butler J, Ho C, Melin S, Case LD, Ennever PR, Magrinat GC, Bearden JD, Minotto DC, Howerton R, Levine E, Blackstock AW. Phase II trial of induction gemcitabine/CPT-11 followed by a twice-weekly infusion of gemcitabine and concurrent external beam radiation for the treatment of locally advanced pancreatic cancer. Am J Clin Oncol. 2005 Aug;28(4):345-50. doi: 10.1097/01.coc.0000159559.42311.c5.

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Clinical Trial Record