Randomized Study With Oxaliplatin In 2nd Line Pancreatic Cancer

Study Overview

Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer

Primary Objective: To demonstrate that the addition of oxaliplatin to 5-Fluorouracil (5-FU) and Leucovorin (LV) will improve the Progression-Free Survival (PFS). Progression is based on RECIST (Response Evaluation Criteria In Solid Tumors) criteria or death Secondary Objective: To evaluate other measures of tumor responses, safety, quality of life (QoL), and health utility assessment.

N/A

Pancreatic Neoplasms

DRUG: Leucovorin
DRUG: OXALIPLATIN
DRUG: 5-Fluorouracil

OXALI_L_04918
U1111-1116-9746 (OTHER Identifier) (OTHER: UTN)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-04-29	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-10-23
First Submitted that Met QC Criteria 2010-05-10	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-10-27
First Posted (ESTIMATED) 2010-05-12	Results First Posted N/A	Last Verified 2014-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: 5-FU & LV * Day 1: LV 400 mg/m2 (given as a 2-hour infusion) * Day 1 and 2: 5-FU given as a bolus IV 400 mg/m2 dose on Day 1 followed by 2400 mg/m2 continuous infusion over 46 hours. * This chemotherapy regimen will be administered each two weeks.	DRUG: Leucovorin Pharmaceutical form:vials of 50 mg/5 mL or 500 mg/50mL Route of administration: IV Dose regimen: DRUG: 5-Fluorouracil Pharmaceutical form: vials of 5 g/100mL Route of administration: IV Dose regimen:
EXPERIMENTAL: XELOX or modified FOLFOX-6 XELOX: * Day 1: Oxaliplatin 130 mg/m2 (2 hours infusion) * This chemotherapy regimen will be administered each two weeks. OR modified FOLFOX-6: * Day 1: Oxaliplatin 85 mg/m2 (given as a 2-hour infusion) * Day 1: LV 400 mg/m2 (given as a 2-hour infusion	DRUG: Leucovorin Pharmaceutical form:vials of 50 mg/5 mL or 500 mg/50mL Route of administration: IV Dose regimen: DRUG: OXALIPLATIN Pharmaceutical form: Lyophilized powder for injection (50 mg/vial or 100 mg/vial) or aqueous solution (50 mg/10 mL and 100 mg/20 mL) Route of administration: IV Dose regimen: DRUG: 5-Fluorouracil Pharmaceutical form: vials of 5 g/100mL Route of administration: IV Dose regimen:

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: 5-FU & LV

* Day 1: LV 400 mg/m2 (given as a 2-hour infusion) * Day 1 and 2: 5-FU given as a bolus IV 400 mg/m2 dose on Day 1 followed by 2400 mg/m2 continuous infusion over 46 hours. * This chemotherapy regimen will be administered each two weeks.

DRUG: Leucovorin

Pharmaceutical form:vials of 50 mg/5 mL or 500 mg/50mL Route of administration: IV Dose regimen:

DRUG: 5-Fluorouracil

Pharmaceutical form: vials of 5 g/100mL Route of administration: IV Dose regimen:

EXPERIMENTAL: XELOX or modified FOLFOX-6

XELOX: * Day 1: Oxaliplatin 130 mg/m2 (2 hours infusion) * This chemotherapy regimen will be administered each two weeks. OR modified FOLFOX-6: * Day 1: Oxaliplatin 85 mg/m2 (given as a 2-hour infusion) * Day 1: LV 400 mg/m2 (given as a 2-hour infusion

DRUG: Leucovorin

Pharmaceutical form:vials of 50 mg/5 mL or 500 mg/50mL Route of administration: IV Dose regimen:

DRUG: OXALIPLATIN

Pharmaceutical form: Lyophilized powder for injection (50 mg/vial or 100 mg/vial) or aqueous solution (50 mg/10 mL and 100 mg/20 mL) Route of administration: IV Dose regimen:

DRUG: 5-Fluorouracil

Pharmaceutical form: vials of 5 g/100mL Route of administration: IV Dose regimen:

Primary Outcome Measures	Measure Description	Time Frame
Progression-Free Survival (PFS)	PFS is defined as the time from the start of treatment to the date of disease progression or death from any cause.	Within the 3 months of study treatment

Secondary Outcome Measures	Measure Description	Time Frame
Overall response rate (ORR)	ORR is based on RECIST criteria and is the percentage of patients with complete response (CR) or partial response (PR).	12 weeks
Duration of response	The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence, i.e. progressive disease (PD) is determined by RECIST criteria or death	12 weeks
Disease Controlled Rate (DCR)	DCR is also based on RECIST criteria and is defined as the percentage of patients who have a CR, PR or stable disease (SD)	12 weeks
Median Overall Survival (OS)	Median Survival is the number of weeks at which 50% of the patients are still alive.	2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically proven pancreatic carcinoma
Measurable locally advanced or metastatic disease
Patient previously treated with 5-FU as a "radiation sensitizer" and all toxicities must have been resolved
Patients must have received Gemcitabine-based chemotherapy (single agent or combination) as 1st line therapy for advanced or metastatic disease and all toxicities must have been resolved
Patients received the last dose of gemcitabine at least 2 weeks prior to randomization
Confirmed radiographic disease progression (Computed Tomogram (CT) scan or Magnetic Resonance Imaging (MRI) within 4 weeks prior to randomization
Adequate liver and kidney function:

Total bilirubin inferior than 1.5 Upper Limit of Normal (ULN)
Creatinine clearance (ClCr) superior than 50 mL / min
Aspartate Transferase (AST) inferior than 3 ULN if no liver metastasis or AST inferior than 5 ULN if liver metastasis
Alanine Aminotransferase (ALT) inferior than 3 ULN if no liver metastasis or ALT inferior than 5 ULN if liver metastasis
Adequate hematological function:

Neutrophils superior or egal to 1.5 x 109/L
Platelets superior or egal to 100 x 109/L

Peripheral sensory or motor neuropathy > grade 1
Eastern Cooperative Oncology Group (ECOG) Performance status > 2
Serious cardiac arrhythmia, diabetes, or serious active infection or other active illness that would preclude study participation in the opinion of the investigator
Pernicious anemia or other megaloblastic anemia with vitamin B12 deficiency
Previous (greater than 5 years) or current malignancies of other origin within the past 5 years
Lack of physical integrity of the upper gastrointestinal tract, clinically significant malabsorption syndrome, or inability to take oral medications
History of known allergy to oxaliplatin or other platinum compounds, to 5-FU, to LV or to any ingredients in the formulations or the containers
Severe renal impairment (ClCr < 50 mL/min)
Pregnant women or breast-feeding
Patients (male or female) with reproductive potential not implementing accepted and effective method of contraception (the definition of "effective method of contraception" will be based on the investigators' judgment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Clinical Sciences & Operations, Sanofi

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Gill S, Ko YJ, Cripps C, Beaudoin A, Dhesy-Thind S, Zulfiqar M, Zalewski P, Do T, Cano P, Lam WYH, Dowden S, Grassin H, Stewart J, Moore M. PANCREOX: A Randomized Phase III Study of Fluorouracil/Leucovorin With or Without Oxaliplatin for Second-Line Advanced Pancreatic Cancer in Patients Who Have Received Gemcitabine-Based Chemotherapy. J Clin Oncol. 2016 Nov 10;34(32):3914-3920. doi: 10.1200/JCO.2016.68.5776. Epub 2016 Sep 30.

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