Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002689
First received: November 1, 1999
Last updated: July 17, 2013
Last verified: June 2007
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy combined with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of brachytherapy followed by external-beam radiation therapy plus chemotherapy in treating patients who have pancreatic cancer that cannot be removed surgically.


Condition Intervention Phase
Pancreatic Cancer
Drug: dexamethasone
Drug: fluorouracil
Radiation: brachytherapy
Radiation: phosphorus P32
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Interstitial Colloidal 32P Integrated in The Treatment of Non-Resectable Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Duration of remission [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patterns of failure [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: September 1995
Study Completion Date: June 2007
Detailed Description:

OBJECTIVES:

  • Determine the response/remission rate, survival, and degree of local control from interstitial colloidal phosphorus P32 followed by external beam radiotherapy and chemotherapy in patients with unresectable pancreatic cancer.

OUTLINE: Patients are stratified according to prior therapy (yes vs no).

Patients receive dexamethasone intratumorally, then macroaggregated albumin and interstitial phosphorus P32 intratumorally. Most patients receive a second course of this brachytherapy.

Patients then proceed to chemoradiotherapy beginning 7-14 days after brachytherapy. Radiotherapy is administered 5 days a week for 6.4 weeks. Fluorouracil IV is administered every other day for 4 doses during weeks 1 and 2.

Patients are followed monthly for 1 year then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven unresectable adenocarcinoma of the pancreas limited to the head, body, or tail of the pancreas

    • Diameter no greater than 5 cm
    • Volume no greater than 66 mL
  • No ascites (with or without tumor cells)
  • No endoscopically proven tumor penetration of duodenum or stomach

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Hematopoietic:

  • WBC at least 3,000/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 9 g/dL (transfusion allowed)

Hepatic:

  • No hepatic disease
  • At least 50% uptake of technetium-sulfur colloid in normal liver if cirrhosis suspected
  • No vascular occlusion of portal system

Renal:

  • Creatinine no greater than 1.5 mg/dL
  • BUN no greater than 25 mg/dL

Other:

  • No Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
  • Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • If prior chemotherapy, test dose of colloidal phosphorous P32 administered prior to attempted treatment

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to pancreas, liver, or upper gastrointestinal tract

Surgery:

  • No complete surgical resection
  • No splenectomy
  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: NCT00002689

Locations
United States, Georgia
Northside Hospital Cancer Center
Atlanta, Georgia, United States, 30342-1611
United States, New York
Center for Molecular Medicine
Garden City, New York, United States, 11530
Sponsors and Collaborators
Center for Molecular Medicine
Investigators
Study Chair: Stanley E. Order, MD, ScD, FACR Center for Molecular Medicine
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002689     History of Changes
Other Study ID Numbers: CMM-95079, CDR0000064415, CH/UMC-95079, NCI-V95-0760
Study First Received: November 1, 1999
Last Updated: July 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I pancreatic cancer
stage II pancreatic cancer
stage III 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
Dexamethasone
Fluorouracil
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 30, 2014