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

NCT01839799 | Completed Phase 2 Results DMC

• 1 other identifier: UPCC 03213
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Adenocarcinoma

Keywords

Patients; with; resected

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Relapse-free Survival

  In this small trial we will regard a median progression-free survival of 20 months as indicative of potential therapeutic benefit meriting additional study.

  20 months

Study Arms (2)

Arm 1 - FOLFIRINOX

EXPERIMENTAL

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; Radiation: Chemoradiation

Arm 2 - Gemcitabine / Abraxane

EXPERIMENTAL

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; Drug: Abraxane; Radiation: Chemoradiation

Interventions

Gemcitabine DRUG

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

Also known as: Gemzar

Arm 2 - Gemcitabine / Abraxane

Abraxane DRUG

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

Also known as: Paclitaxel

Arm 2 - Gemcitabine / Abraxane

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

Arm 1 - FOLFIRINOX

Chemoradiation RADIATION

Arm 1 - FOLFIRINOX; Arm 2 - Gemcitabine / Abraxane

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 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.

You may not qualify if:

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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Gemcitabine; Albumin-Bound Paclitaxel; Paclitaxel; folfirinox; Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Results Point of Contact

• Title: Jennifer Louie, Program Manager
• Organization: University of Pennsylvania

Jennifer.Louie2@pennmedicine.upenn.edu

215-220-9668

Study Officials

• Peter O'Dwyer, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: April 25, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2017
• Last Updated: February 25, 2021
• Results First Posted: February 25, 2021

Record last verified: 2021-02

Locations

US (1)