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

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

Detailed Description
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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.

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

Conditions
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Pancreatic Adenocarcinoma

Intervention / Treatment
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* Drug: Gemcitabine
* Drug: Abraxane
* Drug: FOLFIRINOX
* Radiation: Chemoradiation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 - FOLFIRINOX<br>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<br>* 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<br>Radiation: Chemoradiation<br> <br> |
| Experimental: Arm 2 - Gemcitabine / Abraxane<br>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<br>* 1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15<br>* Other names: Gemzar;Drug: Abraxane<br>* 125 mg/m2 IV over 30 minutes, day 1, 8, 15<br>* Other names: Paclitaxel;Radiation: Chemoradiation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients, with, resected