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

Abramson Cancer Center at Penn Medicine logo

Abramson Cancer Center at Penn Medicine

Status and phase

Completed
Phase 2

Conditions

Pancreatic Adenocarcinoma

Treatments

Drug: FOLFIRINOX
Drug: Abraxane
Drug: Gemcitabine
Radiation: Chemoradiation

Study type

Interventional

Funder types

Other

Identifiers

NCT01839799
UPCC 03213

Details and patient eligibility

About

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

Full 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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

32 participants in 2 patient groups

Arm 1 - FOLFIRINOX
Experimental group
Description:
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
Treatment:
Drug: FOLFIRINOX
Radiation: Chemoradiation
Arm 2 - Gemcitabine / Abraxane
Experimental group
Description:
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
Treatment:
Drug: Gemcitabine
Drug: Abraxane
Radiation: Chemoradiation

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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