Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer

October 23, 2014 updated by: Sanofi

A Randomized Phase III Study of 5-Fluorouracil-based Regimen With or Without Oxaliplatin as 2nd Line Treatment of Advanced or Metastatic Pancreatic Cancer in Patients Who Have Previously Received Gemcitabine-based Chemotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • Canada
      • Abbotsford, Canada, V2S0C2
        • Investigational Site Number 124015
      • Brampton, Canada, L6V1B4
        • Investigational Site Number 124018
      • Burnaby, Canada, V5G2X6
        • Investigational Site Number 124014
      • Calgary, Canada, T2N 4N2
        • Investigational Site Number 124006
      • Greenfield Park, Canada, J4V2H1
        • Investigational Site Number 124011
      • Hamilton, Canada, L8V5C2
        • Investigational Site Number 124010
      • New Glasgow, Canada
        • Investigational Site Number 124-016
      • Oshawa, Canada, L1G2B9
        • Investigational Site Number 124013
      • Ottawa, Canada, K1Y0W9
        • Investigational Site Number 124012
      • Sherbrooke, Canada, J1H 5N4
        • Investigational Site Number 124004
      • Sudbury, Canada, P3E5J1
        • Investigational Site Number 124008
      • Surrey, Canada, V3V1Z2
        • Investigational Site Number 124007
      • Toronto, Canada, M4N3M5
        • Investigational Site Number 124003
      • Toronto, Canada, M5G2M9
        • Investigational Site Number 124002
      • Vancouver, Canada, N5Z4E6
        • Investigational Site Number 124001

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

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

How is the study designed?

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 simultaneous to oxaliplatin)
  • 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 (Day 1 and 2)
  • 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:

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:

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Within the 3 months of study treatment
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

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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)
Time Frame: 2 years
Median Survival is the number of weeks at which 50% of the patients are still alive.
2 years

Collaborators and Investigators

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

Sponsor

Sanofi

Publications and helpful links

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

General Publications

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 Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

April 29, 2010

First Submitted That Met QC Criteria

May 10, 2010

First Posted (ESTIMATE)

May 12, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 27, 2014

Last Update Submitted That Met QC Criteria

October 23, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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