Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer

NCT01523457 | Completed Phase 2 Results DMC

• 1 other identifier: 1108008901
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study was to determine the progression free survival in patients with metastatic pancreatic cancer and in patients with locally advanced unresectable non-metastatic pancreatic cancer treated with a dose-attenuated modification of folinic acid, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX). Secondary endpoints included: determine objective response rate according to RECIST; determine overall survival; evaluate toxicity; determine rate of resection in locally advanced unresectable stratum; correlate time to progression, objective response, and overall survival with early changes in glucose metabolism using \[18F\]-fluorodeoxyglucose (FDG)-positron emission tomography (PET) scanning.

Conditions

Metastatic Pancreatic Cancer; Pancreatic Cancer

Keywords

metastatic pancreatic cancer; locally advanced pancreatic cancer; FOLFIRINOX; phase II; progression free survival

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  The primary objective of this study is to determine the progression free survival in patients with metastatic pancreatic cancer and in patients with locally advanced unresectable non-metastatic pancreatic cancer treated with a dose-attenuated modification of FOLFIRINOX. Tumour response was determined according to RECIST 1.1 by independent radiology review.

  24 weeks

Secondary Outcomes (5)

• Objective Response Rate

  24 weeks

• Overall Survival

  24 weeks

• Toxicity

  24 weeks

• Rate of Resection in Patients With Locally Advanced Disease

  24 weeks

• Correlate Time to Progression, Objective Response, and Overall Survival With Early Changes in Glucose Metabolism Using FDG-positron Emission Tomography (PET) Scanning

  24 weeks

Study Arms (2)

MPC modified FOLFIRINOX

EXPERIMENTAL

Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.

Drug: Folfirinox

LAPC modified FOLFIRINOX

EXPERIMENTAL

Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.

Drug: Folfirinox

Interventions

Folfirinox DRUG

* Oxaliplatin 85 mg/m2 IV infused over two hours, followed by * Leucovorin 400 mg/m2 IV over two hours * Irinotecan 135 mg/m2 IV over 90 minutes (concurrent with leucovorin during the last 90 min of the leucovorin infusion) * 5-FU 300mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46 hours FOLFIRINOX is a chemotherapy regimen. It is made up of the following four drugs: FOL - folinic acid (leucovorin), a vitamin B derivative that modulates/potentiates/reduces the side effects of fluorouracil; F - fluorouracil (5-FU), a pyrimidine analog and antimetabolite which incorporates into the DNA molecule and stops DNA synthesis; IRIN - irinotecan (Camptosar), a topoisomerase inhibitor, which prevents DNA from uncoiling and duplicating; and OX - oxaliplatin (Eloxatin), a platinum-based antineoplastic agent, which inhibits DNA repair and/or DNA synthesis.

LAPC modified FOLFIRINOX; MPC modified FOLFIRINOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologic or cytologic documentation of pancreatic adenocarcinoma
• Metastatic or locally advanced unresectable disease, including borderline unresectable disease
• Patients with biliary or gastroduodenal obstruction must have drainage or surgical bypass prior to starting chemoradiation
• Measurable or non-measurable assessable disease
• No prior treatment (chemotherapy, biological therapy, or radiotherapy) for metastatic or non-metastatic locally advanced unresectable pancreatic cancer
• months since completion of any prior neoadjuvant or adjuvant therapy (chemotherapy or radiotherapy) for resected pancreatic cancer
• No prior treatment with oxaliplatin or irinotecan
• No prior treatment with fluoruouracil or capecitabine unless administered as a radiosensitizing drug during adjuvant/neoadjuvant chemoradiotherapy after/before resection of pancreatic cancer
• Patients who received chemotherapy \> 2 years ago for malignancies other than pancreatic cancer are eligible, provided that chemotherapy was completed \> 2 years ago and there is no evidence of the second malignancy at the time of study entry
• \> 4 weeks since major surgery
• No other concurrent anticancer therapy
• ECOG Performance Status: 0-1
• Age \> 18
• No other malignancy within past two years except basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer
• Paraffin block or slides must be available

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Smilow Cancer Center

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• Stein SM, James ES, Deng Y, Cong X, Kortmansky JS, Li J, Staugaard C, Indukala D, Boustani AM, Patel V, Cha CH, Salem RR, Chang B, Hochster HS, Lacy J. Final analysis of a phase II study of modified FOLFIRINOX in locally advanced and metastatic pancreatic cancer. Br J Cancer. 2016 Mar 29;114(7):737-43. doi: 10.1038/bjc.2016.45.

  PMID: 27022826 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

folfirinox

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Jill Lacy
• Organization: Yale University

jill.lacy@yale.edu

+1 (203) 737-1600

Study Officials

• Jill Lacy, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: February 1, 2012
• Study Start: October 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: August 30, 2017
• Results First Posted: August 30, 2017

Record last verified: 2017-05

Locations

US (1)