NCT02562716|CompletedPhase 2ResultsDMC

S1505: Combination Chemotherapy or Gemcitabine Hydrochloride and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

A Randomized Phase II Study of Perioperative mFOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

S1505NCI-2015-01236U10CA180888

Study Type

interventional

Target

147

Locations

1 country

Sites

807

Timeline

RegisteredSep 2015

StartedJan 2016

CompletionSep 2022

Brief Summary

This randomized phase II trial studies how well fluorouracil, irinotecan hydrochloride, and oxaliplatin (combination chemotherapy) works and compares to gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating patients with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, oxaliplatin, gemcitabine hydrochloride, and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective than gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating pancreatic cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

147

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jan 2016

Longer than P75 for phase_2

Geographic Reach

1 country

807 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.7 years study duration

First Submitted

Initial submission to the registry

September 25, 2015

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed

3 months until next milestone

Study Start

First participant enrolled

January 6, 2016

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

July 23, 2021

Completed

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2022

Completed

Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

4.4 years

First QC Date

September 25, 2015

Results QC Date

June 1, 2021

Last Update Submit

October 18, 2022

Conditions

Pancreatic Adenocarcinoma Resectable Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (1)

Overall Survival (OS)
OS is the length of time between protocol registration and patient death
Up to 4 years for the estimates of median overall survival. Up to 2 years for Statistical Analysis 1 and 2, comparing the observed 2-year overall survival (OS) to the null hypothesis of 40%, in each arm.

Secondary Outcomes (7)

Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Duration of treatment and follow up until death or 4 years post registration.
Number of Patients Going to Surgery for Resection After Preoperative Chemotherapy.
Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).
Number of Patients Achieving R0 Resection After Preoperative Chemotherapy.
Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).
Number of Participants With a Response Following Preoperative Chemotherapy, Including Confirmed and Unconfirmed, Complete and Partial Response, Per RECIST 1.1.
Up to 6 months post registration (and within 2 to 4 weeks after the last dose of Cycle 3 preoperative chemotherapy.).
Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection.
Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).
+2 more secondary outcomes

Study Arms (2)

Arm I (mFOLFIRINOX, surgery)

EXPERIMENTAL

Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.

Drug: FluorouracilDrug: Irinotecan HydrochlorideDrug: OxaliplatinProcedure: Pancreatectomy

Arm II (gemcitabine, nab-paclitaxel, and surgery)

EXPERIMENTAL

Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.

Drug: Gemcitabine HydrochlorideDrug: Paclitaxel Albumin-Stabilized Nanoparticle FormulationProcedure: Pancreatectomy

Interventions

FluorouracilDRUG

Given IV

Also known as: 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757

Arm I (mFOLFIRINOX, surgery)

Gemcitabine HydrochlorideDRUG

Given IV

Also known as: dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemzar, LY-188011

Arm II (gemcitabine, nab-paclitaxel, and surgery)

Irinotecan HydrochlorideDRUG

Given IV

Also known as: Campto, Camptosar, Camptothecin 11, Camptothecin-11, CPT 11, CPT-11, Irinomedac, U-101440E

Arm I (mFOLFIRINOX, surgery)

OxaliplatinDRUG

Given IV

Also known as: 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669

Arm I (mFOLFIRINOX, surgery)

Paclitaxel Albumin-Stabilized Nanoparticle FormulationDRUG

Given IV

Also known as: ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, nab-paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, protein-bound paclitaxel

Arm II (gemcitabine, nab-paclitaxel, and surgery)

PancreatectomyPROCEDURE

Undergo pancreatectomy

Also known as: Excision of the Pancreas, Pancreas Excision

Arm I (mFOLFIRINOX, surgery)Arm II (gemcitabine, nab-paclitaxel, and surgery)

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients must have histologically or cytologically proven pancreatic adenocarcinoma; histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible
Patients must have measurable disease in the pancreas; computed tomography (CT) scans or magnetic resonance imaging (MRIs) used to assess measurable disease must have been completed within 28 days prior to registration; all disease must be assessed and documented on the baseline tumor assessment form
Patients must have resectable primary tumor based on contrast-enhanced CT or MRI (CT or MRI without contrast as part of positron emission tomography \[PET\]/CT or PET/MRI is NOT acceptable; CT or MRI with contrast as part of PET/CT or PET/MRI is acceptable) of the chest, abdomen, and pelvis, where resectable is defined as:
No involvement of the celiac artery, common hepatic artery, and superior mesenteric artery (and, if present, replaced right hepatic artery)
No involvement, or \< 180° interface between tumor and vessel wall, of the portal vein and/or superior mesenteric vein; and patent portal vein/splenic vein confluence
No evidence of metastatic disease
Note: for tumors of the body and tail of the pancreas, involvement of the splenic artery and vein of any degree is considered resectable disease
CT scans or MRIs used to assess disease at baseline must be submitted for central review
Patients must have surgical consult to verify patient is a surgical candidate within 21 days prior to registration
Patients must not have received prior surgery, radiation therapy, chemotherapy, targeted therapy, or any investigational therapy for pancreatic cancer
Patients must have a Zubrod performance status of 0-1
Absolute neutrophil count (ANC) \>= 1,500/mcL
Platelets \>= 100,000/mcL
Hemoglobin \>= 9 g/dL
Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN)
+9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator

Study Sites (807)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36688, United States

Location

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC