Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer

NCT00456599 | Completed Phase 2 Results DMC

• 2 other identifiers: UMCC 2006.025HUM 4531
• Study Type: interventional
• Target: 71
• Locations: 2 countries
• Sites: 4

Brief Summary

This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Two-year Disease Free Survival.

  The percent of patients alive and disease-free at two years.

  two years

Secondary Outcomes (2)

• Time to Treatment Failure

  2 years

• Overall Survival

  5 years

Study Arms (1)

Oxaliplatin & gemcitabine with radiation

EXPERIMENTAL

This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.

Drug: gemcitabine; Drug: oxaliplatin; Procedure: Radiation

Interventions

gemcitabine DRUG

Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1, 8, and 15 of a treatment cycle.

Also known as: Gemzar

Oxaliplatin & gemcitabine with radiation

oxaliplatin DRUG

Oxaliplatin 85mg/m2 will be infused following gemcitabine over approximately 90 minutes on days 1 and 15 of a treatment cycle.

Also known as: Eloxatin

Oxaliplatin & gemcitabine with radiation

Radiation PROCEDURE

The total dose in a three week treatment block will be 30 Gy in 2.0 Gy fractions.

Also known as: RT

Oxaliplatin & gemcitabine with radiation

Eligibility Criteria

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

You may qualify if:

• Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas.
• Patients must be deemed resectable or borderline resectable based on criteria in section 4.2 prior to registration.
• Patients must have an expected life expectancy of at least 12 weeks and a Zubrod performance status of \< 2.
• Patients must have adequate organ function defined as follows: absolute neutrophil count of \> 1500/mm3, platelets \> 100,000/mm3, serum Cr \< 1.5 mg/dl, total bilirubin \< 3.0 mg/dl with relief of biliary obstruction if present (PTC tube or endobiliary stent).
• Patients must be free of other active systemic malignancy, ongoing infection, including HIV infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
• Patients must be aware of the investigational nature of the therapy and provide written informed consent.
• Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy.
• Patients must not have used any investigational agent in the month before enrollment into the study.

You may not qualify if:

• Patients with neuroendocrine tumors are excluded.
• Patients with preexisting peripheral neuropathy \> grade 2 are ineligible.
• Pregnant or nursing women are ineligible and patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after trial.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Sanofi: collaborator
• Johns Hopkins University: collaborator
• Princess Margaret Hospital, Canada: collaborator
• Ohio State University: collaborator

Study Sites (4)

Johns Hopkins University

Baltimore, Maryland, 21231, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• Kim EJ, Ben-Josef E, Herman JM, Bekaii-Saab T, Dawson LA, Griffith KA, Francis IR, Greenson JK, Simeone DM, Lawrence TS, Laheru D, Wolfgang CL, Williams T, Bloomston M, Moore MJ, Wei A, Zalupski MM. A multi-institutional phase 2 study of neoadjuvant gemcitabine and oxaliplatin with radiation therapy in patients with pancreatic cancer. Cancer. 2013 Aug 1;119(15):2692-700. doi: 10.1002/cncr.28117. Epub 2013 May 29.

  PMID: 23720019 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Oxaliplatin; Radiation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Physical Phenomena

Results Point of Contact

• Title: Mark Zalupski, MD
• Organization: University of Michigan

zalupski@med.umich.edu

734-615-3969

Study Officials

• Mark Zalupski, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 5, 2007
• Study Start: April 1, 2007
• Primary Completion: May 1, 2012
• Study Completion: January 1, 2013
• Last Updated: December 3, 2015
• Results First Posted: April 15, 2014

Record last verified: 2015-11

Locations

US (3); CA (1)