NCT00025168

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2 pancreatic-cancer

Timeline
Completed

Started Nov 2001

Shorter than P25 for phase_2 pancreatic-cancer

Geographic Reach
1 country

7 active sites

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

First Submitted

Initial submission to the registry

October 11, 2001

Completed
21 days until next milestone

Study Start

First participant enrolled

November 1, 2001

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2003

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

1.8 years

First QC Date

October 11, 2001

Last Update Submit

September 7, 2021

Conditions

Pancreatic Cancer

Keywords

stage III pancreatic cancer

Interventions

gemcitabine hydrochlorideDRUG
irinotecan hydrochlorideDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed locally advanced pancreatic cancer * Regional (peri-pancreatic) lymph node involvement allowed * Clinically or surgically staged and considered unresectable or inoperable PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * More than 6 months Hematopoietic: * Granulocyte count at least 1,500/mm3 * Hemoglobin at least 10 g/dL * Platelet count at least 100,000/mm3 Hepatic: * Not specified Renal: * Creatinine no greater than 2.0 mg/dL Other: * 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 PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent anticancer immunotherapy Chemotherapy: * No prior chemotherapy * No other concurrent anticancer chemotherapy Endocrine therapy: * No concurrent anticancer hormonal therapy Radiotherapy: * No prior abdominal-pelvic radiotherapy * No other concurrent anticancer radiotherapy Surgery: * See Disease Characteristics * At least 3 weeks since prior open abdominal surgery * More than 10 days since prior laparoscopy Other: * No other concurrent investigational drug * No concurrent participation in other clinical study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Southeastern Medical Oncology Center

Goldsboro, North Carolina, 27534, United States

Location

East Carolina University School of Medicine

Greenville, North Carolina, 27858-4354, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Spartanburg Regional Healthcare System

Spartanburg, South Carolina, 29303, United States

Location

Related Publications (1)

  • 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.

    PMID: 16062075RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GemcitabineIrinotecanRadiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCamptothecinAlkaloidsTherapeutics

Study Officials

  • Arthur William Blackstock, MD

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2001

First Posted

January 27, 2003

Study Start

November 1, 2001

Primary Completion

August 29, 2003

Study Completion

August 29, 2003

Last Updated

September 9, 2021

Record last verified: 2021-09

Locations

US(7)