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Completed

NCT Number: NCT01839799

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

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

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Key information

Conditions

Pancreatic Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gemcitabine

Drug

1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15

Other names: Gemzar

Abraxane

Drug

125 mg/m2 IV over 30 minutes, day 1, 8, 15

Other names: Paclitaxel

Folfirinox

Drug

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

Chemoradiation

Radiation

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 25, 2013
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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