Neoplasms

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Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

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Gastrointestinal Neoplasms

Digestive System Neoplasms

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Gastrointestinal Diseases

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Endocrine System Diseases

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Gastrointestinal Agents

Irinotecan

Fluorouracil

Oxaliplatin

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Pancrelipase

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Topoisomerase I Inhibitors

Enzyme Inhibitors

Single arm, treated with neoadjuvant FOLFIRINOX prior to surgical resection

6 cycles of FOLFIRINOX prior to surgical resection: Eloxatin® (Oxaliplatin) 85 mg per square meter 2-hour IV infusion Camptosar® (Irinotecan Hydrochloride) 180 mg per square meter 90-minute IV infusion via Y-connector adrucil (Fluorouracil; 5-FU)2400 mg per square meter 46-hour IV infusion

FOLFIRINOX Regimen

Scott Celinski, MD

A prospective evaluation of neoadjuvant FOLFIRINOX regimen in patients with non-metastatic pancreas cancer (Baylor University Medical Center and Texas Oncology Experience)

Patients with pancreas cancer will be enrolled and treated with a planned course of 6 cycles (3 months) of chemotherapy with FOLFIRINOX prior to undergoing surgical resection.

Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer

A Prospective Evaluation of Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancreas Cancer (Baylor University Medical Center and Texas Oncology Experience)

Baylor Research Institute

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Micronutrients

Hematinics

Vitamins

Leucovorin

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded.

5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently

Irinotecan, Oxaliplatin, Leucovorin, 5-FU

Shubham Pant, MD

The prognosis of patients with locally advanced unresectable pancreatic cancer is poor, and the median survival is less than 1 year. FOLFIRINOX therapy, which induces tumor downstaging sufficient to allow surgical resection, could improve the overall survival of patients with locally advanced pancreatic cancer. Based on the FOLFIRINOX regimen for advanced pancreatic cancer, a phase II study of this regimen in patients with locally advanced unresectable and borderline pancreatic cancer is planned to determine the rate of conversion to operability.

FOLFIRINOX in Patients With Inoperable Pancreatic Cancer

A Phase II Study Evaluating the Rate of R0 Resection (Microscopically Negative Margins) After Induction Therapy With 5- Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan (FOLFIRINOX) in Patients With Borderline Resectable or Locally Advanced Inoperable Pancreatic Cancer.

University of Oklahoma

Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded.

Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently

FOLFIRINOX

Age, Continuous

Sex: Female, Male

Race

Race (NIH/OMB)

United States

Region of Enrollment

Ingrid Block - CTO Directo

5-FU, Leucovorin, Oxaliplatin, Irinotecan

Data was not collected from any single study participant.

To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy.

Data was not collected from any single study participant

Proportion of Patients Whose Pancreatic Cancer is Operable (Resulting in R0 or R1 Resection) Following Induction Therapy.

Response Rate (Either Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria)

Overall Survival

Number of Participants Who Experienced Toxicity

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer	NCT01771146	Pancreas Cancer Localized Pancr... Non-metastatic ...	FOLFIRINOX Regi...	18 Years -	Baylor Research Institute
FOLFIRINOX in Patients With Inoperable Pancreatic Cancer	NCT01359007	Adenocarcinoma ...	Irinotecan, Oxa...	18 Years - 70 Years	University of Oklahoma

Spots Global Cancer Trial Database for adenocarcinoma of pancreas