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Radiation Therapy and Capecitabine/Oxaliplatin Chemotherapy in the Treatment of Locally Advanced Pancreas Adenocarcinoma
This study is ongoing, but not recruiting participants.
First Received: June 26, 2008   Last Updated: December 8, 2009   History of Changes
Sponsor: University of Utah
Information provided by: University of Utah
ClinicalTrials.gov Identifier: NCT00707278
  Purpose

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.


Condition Intervention Phase
Cancer
Pancreas
Radiation: Radiation Therapy
Drug: Capecitabine
Drug: Oxaliplatin
Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Prospective Phase I Study of Radiation Therapy and Concurrent Capecitabine and Oxaliplatin Chemotherapy in the Treatment of Locally Advanced Pancreas Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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. [ Time Frame: September 2012 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: September 2012 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: September 2005
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Radiation Therapy
    Radiation therapy will be delivered concurrently with capecitabine and oxaliplatin chemotherapy Radiation therapy dose will be 50.4 Gy (1.8 Gy per day, 5 days per week, for 28 treatments).
    Drug: Capecitabine
    Capecitabine Dose (given twice daily concurrent with radiation therapy) Dose level 1: 400 mg/m2 Dose level 2:600 mg/m2 Dose level 3:600 mg/m2
    Drug: Oxaliplatin
    Oxaliplatin Dose (given weekly concurrent with radiation therapy) Dose level 1: 50 mg/m2 Dose level 2: 50 mg/m2 Dose level 3: 60 mg/m2
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00707278

Locations
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Dennis Shrieve, MD Huntsman Cancer Institute
  More Information

No publications provided

Responsible Party: University of Utah/Huntsman Cancer Hospital ( Dennis Shrieve, MD )
Study ID Numbers: HCI # 13633
Study First Received: June 26, 2008
Last Updated: December 8, 2009
ClinicalTrials.gov Identifier: NCT00707278     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Antimetabolites
Capecitabine
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Oxaliplatin
Therapeutic Uses
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010