A Study of Gemcitabine and Cyberknife Radiation Therapy for Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael J Pishvaian, Georgetown University
ClinicalTrials.gov Identifier:
NCT01051284
First received: January 15, 2010
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

People with pancreatic cancer that cannot be cured by surgery are being asked to participate in this study.

The purpose of this study is to test the ability of the radiation oncologists to administer Cyberknife therapy along with Gemcitabine chemotherapy for patients with pancreatic cancer. Radiation and Gemcitabine are both effective at killing cancer cells but they generally cannot be given at the same time. Cyberknife therapy is highly focused radiation that is being used extensively at Georgetown University and around the United States to treat a number of cancers. It is believed that because Cyberknife is so highly focused it can be given safely with regular doses of chemotherapy to attack cancer cells in two ways at the same time.

This research is being done because it is not known if using Cyberknife with chemotherapy will be a safe way to treat pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Radiation: Cyberknife radiation and gemcitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Full Dose Gemcitabine and Hypofractionated Stereotactic Radiosurgery in the Treatment of Unresectable Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • To demonstrate that radiation treatments can be reproduced as determined by evaluation of the prescription isodose curves [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Acute and late toxicity as determined by patient self-reporting instruments that assess gastrointestinal side effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Quality of life as determined by patient self-reporting instruments [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Acute stomach/duodenal mucosa injury as assessed by upper endoscopy [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Late stomach/duodenal mucosa injury as assessed by upper endoscopy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Feasibility of integrating metabolomic analysis into the evaluation of patients with unresectable pancreatic cancer undergoing chemotherapy and radiation therapy measured by the ability to collect tumor specimens [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The feasibility of measuring pancreatic cancer stem cell populations by analysis of fine needle aspirate specimens [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: November 2009
Study Completion Date: March 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cyberknofe and Gemcitabine
Cyberknife radiation and 6 cycles Gemcitabine
Radiation: Cyberknife radiation and gemcitabine
25 Gray of radiation will be given in 5 fractions using the Cyberknife Gemcitabine 1000 mg/m2 intravenously will be given once a week on days 1, 8, and 15 of every 28-day cycle for 6 cycles
Other Names:
  • Gemcitabine
  • Gemzar

Detailed Description:

This is a single arm, open-label pilot study of Cyberknife plus Gemcitabine in 10 patients with locally advanced pancreatic cancer who have not received prior local or systemic therapy for their pancreatic cancer.

  Eligibility

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

Inclusion Criteria:

  • Histologically proven unresectable, non-metastatic pancreatic adenocarcinoma with measurable or evaluable disease and without involvement of the duodenum
  • Performance Status 0-2
  • No prior anticancer therapy for pancreatic adenocarcinoma
  • No prior anticancer therapy of any kind within the last 5 years
  • Adequate hepatic, bone marrow, and renal function
  • Life expectance of > 12 weeks
  • Women of childbearing potential must have a negative serum pregnancy test

Exclusion Criteria:

  • Duodenal involvement of pancreatic cancer
  • Metastatic cancer
  • Active severe infection, or known chronic infection with HIV, hepatitis B virus, or hepatitis C virus
  • Cardiovascular disease including unstable angina, therapy for life-threatening ventricular arrhythmia, myocardial infarction, stroke, or congestive heart failure within the last 6 months
  • Life-threatening visceral disease or other severe concurrent disease
  • Pregnant or breastfeeding
  • Anticipated patient survival under 3 months
  • Another active malignancy within the past 5 years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.
  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: NCT01051284

Locations
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Michael J Pishvaian, MD, PhD Georgetown University
  More Information

No publications provided

Responsible Party: Michael J Pishvaian, Assistant Professor, Georgetown University
ClinicalTrials.gov Identifier: NCT01051284     History of Changes
Other Study ID Numbers: 2009-169
Study First Received: January 15, 2010
Last Updated: April 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
Pancreas
Newly diagnosed
Cyberknife
Gemcitabine

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 August 28, 2014