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Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gemcitabine hydrochloride
adjuvant therapy
radiation therapy
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage I pancreatic cancer, adenocarcinoma of the pancreas

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed invasive adenocarcinoma of the pancreas Prior gross total resection via a pancreaticoduodenectomy (Whipple resection or total pancreatectomy) within the past 2 months No clinical evidence of gross residual disease at time of surgery No focally positive margins (tumor at the margin) No unresected nodal disease or metastatic disease to the liver, peritoneal surfaces, or elsewhere PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: More than 6 months Hematopoietic: Granulocyte count greater than 1,500/mm3 Hemoglobin greater than 10 g/dL Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 2.0 mg/dL Other: Able to maintain adequate oral nutrition Documented stable weight (no more than 5 lbs weight loss) for at least 2 weeks prior to study No other malignancy within the past 2 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix or breast Non-metastatic prostate cancer allowed if more than 2 year survival likely No other serious medical or psychiatric illness that would preclude study or limit survival to less than 2 years Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent routine growth factors Chemotherapy: No prior chemotherapy for pancreatic cancer Endocrine therapy: Not specified Radiotherapy: No prior abdominal radiotherapy for pancreatic cancer Surgery: See Disease Characteristics

Sites / Locations

  • Comprehensive Cancer Center at Wake Forest University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
September 7, 2021
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00010166
Brief Title
Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas
Official Title
Phase II Trial Of Adjuvant 2'2'-Difluoro-2'-Deoxycytidine (Gemcitabine) And External Beam Radiation For The Treatment Of Resectable Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2000 (Actual)
Primary Completion Date
October 3, 2003 (Actual)
Study Completion Date
October 3, 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gemcitabine may make tumor cells more sensitive to radiation therapy. Combining chemotherapy with radiation therapy after surgery may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with radiation therapy in treating patients who have undergone surgery to remove cancer of the pancreas.
Detailed Description
OBJECTIVES: Determine the time to disease progression, local control, and survival of patients with previously resected pancreatic cancer treated with adjuvant gemcitabine and radiotherapy. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32 and undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38 in the absence of disease progression or unacceptable toxicity. Beginning at least 4 weeks after chemoradiotherapy, patients without disease progression and with less than 10% weight loss during study receive additional gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 2 courses. Patients are followed every 8 weeks for 6 months and then every 3 months for up to 2 years. PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 2.2 or 3.4 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage I pancreatic cancer, adenocarcinoma of the pancreas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed invasive adenocarcinoma of the pancreas Prior gross total resection via a pancreaticoduodenectomy (Whipple resection or total pancreatectomy) within the past 2 months No clinical evidence of gross residual disease at time of surgery No focally positive margins (tumor at the margin) No unresected nodal disease or metastatic disease to the liver, peritoneal surfaces, or elsewhere PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: More than 6 months Hematopoietic: Granulocyte count greater than 1,500/mm3 Hemoglobin greater than 10 g/dL Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 2.0 mg/dL Other: Able to maintain adequate oral nutrition Documented stable weight (no more than 5 lbs weight loss) for at least 2 weeks prior to study No other malignancy within the past 2 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix or breast Non-metastatic prostate cancer allowed if more than 2 year survival likely No other serious medical or psychiatric illness that would preclude study or limit survival to less than 2 years Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent routine growth factors Chemotherapy: No prior chemotherapy for pancreatic cancer Endocrine therapy: Not specified Radiotherapy: No prior abdominal radiotherapy for pancreatic cancer Surgery: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur William Blackstock, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16868545
Citation
Blackstock AW, Mornex F, Partensky C, Descos L, Case LD, Melin SA, Levine EA, Mishra G, Limentani SA, Kachnic LA, Tepper JE. Adjuvant gemcitabine and concurrent radiation for patients with resected pancreatic cancer: a phase II study. Br J Cancer. 2006 Aug 7;95(3):260-5. doi: 10.1038/sj.bjc.6603270. Epub 2006 Jul 25.
Results Reference
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Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas

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