A Study of Gemcitabine and Cyberknife Radiation Therapy for Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

A Pilot Study of Full Dose Gemcitabine and Hypofractionated Stereotactic Radiosurgery in the Treatment of Unresectable Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051284
• Other study ID #: 2009-169
• Status: Completed
• Phase: Phase 1
• First received: January 15, 2010
• Last updated: April 23, 2012
• Start date: November 2009
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate that radiation treatments can be reproduced as determined by evaluation of the prescription isodose curves		10 days	Yes
Secondary	Acute and late toxicity as determined by patient self-reporting instruments that assess gastrointestinal side effects		6 months	Yes
Secondary	Quality of life as determined by patient self-reporting instruments		6 months	No
Secondary	Acute stomach/duodenal mucosa injury as assessed by upper endoscopy		one month	Yes
Secondary	Late stomach/duodenal mucosa injury as assessed by upper endoscopy		6 months	Yes
Secondary	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		6 months	No
Secondary	The feasibility of measuring pancreatic cancer stem cell populations by analysis of fine needle aspirate specimens		6 months	No