FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer (NCT01688336) | Clinical Trial Compass
TerminatedPhase 2
FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer
Stopped: Results unlikely to impact treatment patterns. Time to complete not justified.
United States9 participantsStarted 2012-01
Plain-language summary
This single arm, multi-center phase II clinical trial will assess the safety and efficacy of FOLFIRINOX in the first-line setting in patients with unresectable locally advanced (ULA) and borderline resectable (BR) pancreatic cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Biopsy confirmed adenocarcinoma of the pancreas.
* Measurable or non-measurable but evaluable (as determined by Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\]) unresectable locally advanced (ULA) or borderline resectable (BR) disease that is not amenable to curative intent therapy. Baseline CT abdomen and chest (or MRI abdomen) within 28 days prior to initiation of FOLFIRINOX is required.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* No prior chemotherapy or chemoradiotherapy for pancreatic cancer.
* Age ≥ 18 years of age.
* Laboratory requirements at study entry:
* Hemoglobin ≥ 10 g/dL (transfusions are acceptable)
* absolute neutrophil count (ANC) ≥ 1.5 x 109/L
* Platelets ≥ 100 x 109/L
* Creatinine ≤ 1.5 x upper limit of normal (ULN), or creatinine clearance ≥ 50 mL/min (estimated by Cockcroft-Gault or measured)
* Total bilirubin ≤ 1.5 x ULN
* aspartate aminotransferase/Alanine Aminotransferase (AST/ALT) ≤ 3 x ULN
* Gamma-Glutamyl Transferase (GGT) ≤ 5 x ULN
* Life expectancy of at least 6 months.
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test performed within 14 days prior to initiation of FOLFIRINOX.
* WOCBP and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and 8 weeks after the end of treatment.
* Before patient registration, written informed consent must be given.
Exclusion…
What they're measuring
1
Median Overall Survival (OS) of FOLFIRINOX in Patients With Unresectable Locally Advanced (ULA) Pancreatic Cancer