A Prospective Phase I Study of Radiation Therapy and Concurrent Capecitabine and Oxaliplatin Chemotherapy in the Treatment of Locally Advanced Pancreas Adenocarcinoma
18 Years
N/A
Both
Cancer, Pancreas
Trial Information
A Prospective Phase I Study of Radiation Therapy and Concurrent Capecitabine and Oxaliplatin Chemotherapy in the Treatment of Locally Advanced Pancreas Adenocarcinoma
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.
Inclusion Criteria
Patient Selection Criteria
- Pathologically confirmed adenocarcinoma of the pancreas.
- No distant metastases (no metastases beyond regional lymph nodes).
- Deemed surgically unresectable by a surgical oncologist due to hepatic artery, celiac
axis, superior mesenteric artery, superior mesenteric vein, portal vein, aorta,
inferior vena cava, and/or rib/vertebral body involvement as defined by CT/MRI scan
and/or endoscopic ultrasound (EUS).
- No malignancy (within the past two years) except for non-melanomatous skin cancer or
carcinoma in situ of the cervix, uterus, or bladder.
- No previous chemotherapy for pancreatic cancer.
- No prior irradiation to the planned field.
- 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.
- No significant infection or other coexistent medical condition.
- No pregnant or lactating women.
- Age > 18 years old.
- Signed study-specific consent form prior to registration.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
September 2012
Safety Issue:
Yes
Principal Investigator
Dennis Shrieve, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Huntsman Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
HCI13633
NCT ID:
NCT00707278
Start Date:
September 2005
Completion Date:
August 2011
Related Keywords:
- Cancer
- Pancreas
- Adenocarcinoma
- Adenocarcinoma, Mucinous
Name | Location |
|---|---|
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
