Clinical trial NCT01051284: A Study of Gemcitabine and Cyberknife Radiation Therapy for Pancreatic Cancer
Official title: A Pilot Study of Full Dose Gemcitabine and Hypofractionated Stereotactic Radiosurgery in the Treatment of Unresectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Cancer
Keywords: Pancreas
Newly diagnosed
Cyberknife
Gemcitabine
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2010-01-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: To demonstrate that radiation treatments can be reproduced as determined by evaluation of the prescription isodose curves
timeFrame: 10 days
Secondary outcomes:
measure: Acute and late toxicity as determined by patient self-reporting instruments that assess gastrointestinal side effects
timeFrame: 6 months
measure: Quality of life as determined by patient self-reporting instruments
timeFrame: 6 months
measure: Acute stomach/duodenal mucosa injury as assessed by upper endoscopy
timeFrame: one month
measure: Late stomach/duodenal mucosa injury as assessed by upper endoscopy
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: The feasibility of measuring pancreatic cancer stem cell populations by analysis of fine needle aspirate specimens
timeFrame: 6 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Michael J Pishvaian, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: