Radiation Therapy and Capecitabine/Oxaliplatin Chemotherapy in the Treatment of Locally Advanced Pancreas Adenocarcinoma

NCT00707278 | Completed Phase 1 DMC

• 1 other identifier: HCI13633
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Pancreas

Outcome Measures

Primary Outcomes (1)

• 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.

  September 2012

Secondary Outcomes (1)

• 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.

  September 2012

Study Arms (1)

All patients

EXPERIMENTAL

All participants enrolled.

Radiation: Radiation Therapy; Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Radiation Therapy RADIATION

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).

All patients

Capecitabine DRUG

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

Also known as: Chemotherapy

All patients

Oxaliplatin DRUG

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

Also known as: chemotherapy

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Radiotherapy; Capecitabine; Drug Therapy; Oxaliplatin

Intervention Hierarchy (Ancestors)

Therapeutics; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Dennis Shrieve, MD

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: June 30, 2008
• Study Start: September 1, 2005
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 31, 2014

Record last verified: 2014-10

Locations

US (1)