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A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01839799
Recruitment Status : Completed
First Posted : April 25, 2013
Results First Posted : February 25, 2021
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
Determine the relapse-free survival of resected pancreatic cancer patients following two novel regimens with activity in advanced disease.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Drug: Gemcitabine Drug: Abraxane Drug: FOLFIRINOX Radiation: Chemoradiation Phase 2

Detailed Description:
This trial is a randomized Phase II study of FOLFIRINOX versus gemcitabine/abraxane in patients with completely resected pancreatic cancer (Stages I-III). Patients will receive eight weeks of chemotherapy, then 5-FU/radiation, then another 8 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma
Actual Study Start Date : April 2013
Actual Primary Completion Date : April 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1 - FOLFIRINOX

FOLFIRINOX:

Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles over 8 weeks

Chemoradiation:

Radiation to begin no sooner than 28 days from last day of chemotherapy.

On Day 1(+ 2days to accommodate scheduling difficulties):

Infusional 5-FU (225 mg/m2 continuous infusion during radiation) and radiation therapy as defined.

FOLFIRINOX:

Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated

Drug: FOLFIRINOX
Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated

Radiation: Chemoradiation
Experimental: Arm 2 - Gemcitabine / Abraxane

Gemcitabine / Abraxane Gemcitabine 1000 mg/m2 Days 1, 8, 15 Abraxane 125 mg/m2 Days 1, 8, 15 Two cycles over 8 weeks

Chemoradiation:

Radiation to begin no sooner than 28 days from last day of chemotherapy. On Day 1 (+ 2days to accommodate scheduling difficulties) Infusional 5-FU (225 mg/m2 continuous infusion during radiation) and radiation therapy as defined.

Gemcitabine / Abraxane Gemcitabine 1000 mg/m2 Days 1, 8, 15 Abraxane 125 mg/m2 Days 1, 8, 15 Two cycles, if tolerated

Drug: Gemcitabine
1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15
Other Name: Gemzar

Drug: Abraxane
125 mg/m2 IV over 30 minutes, day 1, 8, 15
Other Name: Paclitaxel

Radiation: Chemoradiation



Primary Outcome Measures :
  1. Number of Participants With Relapse-free Survival [ Time Frame: 20 months ]
    In this small trial we will regard a median progression-free survival of 20 months as indicative of potential therapeutic benefit meriting additional study.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed evidence of pancreatic carcinoma.
  • Patients must have had all gross disease resected (R0 or R1 resection, patients who underwent an R2 resection are not eligible).
  • Patients must have had no prior chemotherapy or radiation therapy for pancreatic cancer.
  • Age > 18 years.
  • Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Patients must have normal organ and marrow function measured within 2 weeks, prior to registration as follows:

Absolute Neutrophil Count (ANC) > 1,500/µL Platelets > 100,000/µL Total bilirubin less than 2-fold upper limit of normal (ULN) Aspartate Aminotransferase (AST)/alanine aminotransferase (ALT)<2.5X institutional upper limit of normal Creatinine clearance > 60mL/min for patients with creatinine levels above institutional normal.

  • Patients must be > 4 weeks and < 12 weeks post-surgery at time of study registration.
  • Women of childbearing potential and sexually active males are strongly advised to use appropriate contraceptive measures.
  • Women must not be pregnant or breast-feeding.

Exclusion Criteria:

  • Patients receiving any other investigational agents.
  • Patients with known metastases.
  • Patients with wounds that have not fully healed.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839799


Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Peter O'Dwyer, MD Abramson Cancer Center of the University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by Abramson Cancer Center of the University of Pennsylvania:
Informed Consent Form  [PDF] March 10, 2016

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01839799    
Other Study ID Numbers: UPCC 03213
First Posted: April 25, 2013    Key Record Dates
Results First Posted: February 25, 2021
Last Update Posted: February 25, 2021
Last Verified: February 2021
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Patients
with
resected
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Folfirinox
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs