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

NCT ID: NCT01839799

Last Updated: 2021-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2017-07-31

Brief Summary

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

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.

Conditions

Pancreatic Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

FOLFIRINOX

Intervention Type: 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

Intervention Type: RADIATION

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

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

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

Abraxane

Intervention Type: DRUG

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

Chemoradiation

Intervention Type: RADIATION

Interventions

Gemcitabine

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

Intervention Type: DRUG

Abraxane

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

Intervention Type: 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

Intervention Type: DRUG

Chemoradiation

Intervention Type: RADIATION

Other Intervention Names

Gemzar; Paclitaxel

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter O'Dwyer, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UPCC 03213

Identifier Type: -

Identifier Source: org_study_id