Phase 2
N=32
A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma
Pancreatic Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01839799 ↗Enrolled (actual)
32
Serious AEs
31.3%
Results posted
Feb 2021
Primary outcome: Primary: Number of Participants With Relapse-free Survival — 3; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gemcitabine (Drug); Abraxane (Drug); FOLFIRINOX (Drug); Chemoradiation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Relapse-free Survival |
3; 2 | — |
Summary
Determine the relapse-free survival of resected pancreatic cancer patients following two novel regimens with activity in advanced disease.
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) 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.
Data sourced from ClinicalTrials.gov (NCT01839799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.