Radiation Therapy and Capecitabine/Oxaliplatin Chemotherapy in the Treatment of Locally Advanced Pancreas Adenocarcinoma
Information source: University of Utah
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer; Pancreas
Intervention: Radiation Therapy (Radiation); Capecitabine (Drug); Oxaliplatin (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: University of Utah Official(s) and/or principal investigator(s):
Lisa J Hazard, MD, Principal Investigator, Affiliation: Huntsman Cancer Institute
Overall contact:
Crelley Mackey, Phone: 801-581-3916, Email: crelley.mackey@hci.utah.edu
Summary
The study is a prospective phase I trial of radiation therapy concurrent with capecitabine
and oxaliplatin chemotherapy in the treatment of locally advanced pancreas adenocarcinoma.
Eligibility criteria include pathologically confirmed, non-metastatic adenocarcinoma of the
pancreas that is surgically unresectable. Patients will undergo radiation therapy (28
treatments of 1. 8 Gy for a total of 50. 4 Gy) concurrent with capecitabine and oxaliplatin
chemotherapy. The primary objective of the study is to determine the maximum tolerated doses
of capecitabine and oxaliplatin when delivered concurrently with 50. 4 Gy radiation therapy
with or without surgery in this patient population.
Secondary objectives of the study are to determine the tumor response rate, survival rate,
local control rate and the rate of distant metastases following capecitabine, oxaliplatin,
and radiation therapy with or without surgery and to determine the rate at which patients
with unresectable disease become resectable.
Clinical Details
Official title: A Prospective Phase I Study of Radiation Therapy and Concurrent Capecitabine and Oxaliplatin Chemotherapy in the Treatment of Locally Advanced Pancreas Adenocarcinoma
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To determine the maximum tolerated doses of capecitabine and oxaliplatin when delivered concurrently with 50.4 Gy radiation therapy with or without surgery in patients with locally advanced pancreas adenocarcinoma.
Secondary outcome: To determine tumor response rate, survival rate, local control rate and rate of distant metastases following capecitabine, oxaliplatin, and radiation therapy with or without surgery in patients with locally advanced pancreas adenocarcinoma.
Detailed description:
Patients will undergo radiation therapy (28 treatments of 1. 8 Gy for a total of 50. 4 Gy)
concurrent with capecitabine and oxaliplatin chemotherapy. The primary objective of the study
is to determine the maximum tolerated doses of capecitabine and oxaliplatin when delivered
concurrently with 50. 4 Gy radiation therapy with or without surgery in this patient
population.
Three dose levels are planned, as shown in the "Dose Escalation" table below. Three patients
are planned at each level. When 3 patients have completed an entire chemoradiation course and
are monitored for at least 2 weeks after the end of treatment without the occurrence of dose
limiting toxicities (DLTs), then the next 3 patients will be treated at the next highest dose
level. If one of the first three patients treated at any given dose level experiences a DLT,
three further patients will be treated at that level. If only one in six patients at a given
level experiences a DLT, escalation can proceed. If two or more of three to six patients at
the lowest administered dose level experience DLTs, then the MTD is below the lowest
administered dose, but no specific MTD will be defined. If two or more of three to six
patients at a higher dose level experiences DLTs, the dose preceding the lowest dose level
satisfying this criterion will be declared the MTD. If all the dose levels are exhausted
without two or more of three to six patients experiencing DLTs, then the MTD is higher than
the maximum administered dose, but no specific MTD will be defined. If MTD is reached at a
given dose level, then additional patients can be accrued to the next lowest dose level, such
that up to six patients can be accrued to the dose level below MTD. Because three dose levels
are planned, with 3 to 6 patients enrolled in each dose level, a minimum of 9 and a maximum
of 18 patients are required for trial completion.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Pathologically confirmed adenocarcinoma of the pancreas.
- Deemed surgically unresectable by CT/MRI scan and/or EUS.
- Patients with biliary or gastro-duodenal obstruction must have drainage prior to
starting chemoradiation.
- All malignant disease must be encompassable within a single irradiation field (15 x 15
cm maximum dimension).
- Zubrod performance status 0-1.
- Granulocytes > 1,800, platelets > 100,000/ul, bilirubin < 2. 0 mg/dL, ALT < 3x upper
limits of normal, creatinine < 3. 0 mg/dL.
- Signed study-specific consent form prior to registration.
Exclusion criteria:
- Distant metastases (metastases beyond regional lymph nodes).
- Malignancy(within the past two years) except for non-melanomatous skin cancer or
carcinoma in situ of the cervix, uterus, or bladder.
- Previous chemotherapy for pancreatic cancer.
- Prior irradiation to the planned field.
- Significant infection or other coexistent medical condition.
- Pregnancy or lactation.
Locations and Contacts
Crelley Mackey, Phone: 801-581-3916, Email: crelley.mackey@hci.utah.edu
Huntsman Cancer Institute, Salt Lake City, Utah 84112, United States; Recruiting
Lisa J Hazard, MD, Principal Investigator
Additional Information
Starting date: September 2005
Ending date: September 2012
Last updated: December 17, 2008
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