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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT00010166
First received: February 2, 2001
Last updated: August 20, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: gemcitabine hydrochloride
Procedure: adjuvant therapy
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Trial Of Adjuvant 2'2'-Difluoro-2'-Deoxycytidine (Gemcitabine) And External Beam Radiation For The Treatment Of Resectable Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

Study Start Date: December 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010166

Locations
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Sponsors and Collaborators
Wake Forest Baptist Health
Investigators
Study Chair: Arthur William Blackstock, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00010166     History of Changes
Other Study ID Numbers: CDR0000068452, CCCWFU-57198, NCI-104
Study First Received: February 2, 2001
Last Updated: August 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Wake Forest Baptist Health:
stage I pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 24, 2014