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Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer

Primary Purpose

Pancreatic Neoplasms

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Leucovorin
OXALIPLATIN
5-Fluorouracil
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 124015
  • Investigational Site Number 124018
  • Investigational Site Number 124014
  • Investigational Site Number 124006
  • Investigational Site Number 124011
  • Investigational Site Number 124010
  • Investigational Site Number 124-016
  • Investigational Site Number 124013
  • Investigational Site Number 124012
  • Investigational Site Number 124004
  • Investigational Site Number 124008
  • Investigational Site Number 124007
  • Investigational Site Number 124003
  • Investigational Site Number 124002
  • Investigational Site Number 124001

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

5-FU & LV

XELOX or modified FOLFOX-6

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall response rate (ORR)
ORR is based on RECIST criteria and is the percentage of patients with complete response (CR) or partial response (PR).
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
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)
Median Overall Survival (OS)
Median Survival is the number of weeks at which 50% of the patients are still alive.

Full Information

First Posted
April 29, 2010
Last Updated
October 23, 2014
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01121848
Brief Title
Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5-FU & LV
Arm Type
Active Comparator
Arm Description
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.
Arm Title
XELOX or modified FOLFOX-6
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
Pharmaceutical form:vials of 50 mg/5 mL or 500 mg/50mL Route of administration: IV Dose regimen:
Intervention Type
Drug
Intervention Name(s)
OXALIPLATIN
Intervention Description
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:
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Intervention Description
Pharmaceutical form: vials of 5 g/100mL Route of administration: IV Dose regimen:
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS is defined as the time from the start of treatment to the date of disease progression or death from any cause.
Time Frame
Within the 3 months of study treatment
Secondary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
ORR is based on RECIST criteria and is the percentage of patients with complete response (CR) or partial response (PR).
Time Frame
12 weeks
Title
Duration of response
Description
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
Time Frame
12 weeks
Title
Disease Controlled Rate (DCR)
Description
DCR is also based on RECIST criteria and is defined as the percentage of patients who have a CR, PR or stable disease (SD)
Time Frame
12 weeks
Title
Median Overall Survival (OS)
Description
Median Survival is the number of weeks at which 50% of the patients are still alive.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 124015
City
Abbotsford
ZIP/Postal Code
V2S0C2
Country
Canada
Facility Name
Investigational Site Number 124018
City
Brampton
ZIP/Postal Code
L6V1B4
Country
Canada
Facility Name
Investigational Site Number 124014
City
Burnaby
ZIP/Postal Code
V5G2X6
Country
Canada
Facility Name
Investigational Site Number 124006
City
Calgary
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Investigational Site Number 124011
City
Greenfield Park
ZIP/Postal Code
J4V2H1
Country
Canada
Facility Name
Investigational Site Number 124010
City
Hamilton
ZIP/Postal Code
L8V5C2
Country
Canada
Facility Name
Investigational Site Number 124-016
City
New Glasgow
Country
Canada
Facility Name
Investigational Site Number 124013
City
Oshawa
ZIP/Postal Code
L1G2B9
Country
Canada
Facility Name
Investigational Site Number 124012
City
Ottawa
ZIP/Postal Code
K1Y0W9
Country
Canada
Facility Name
Investigational Site Number 124004
City
Sherbrooke
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Investigational Site Number 124008
City
Sudbury
ZIP/Postal Code
P3E5J1
Country
Canada
Facility Name
Investigational Site Number 124007
City
Surrey
ZIP/Postal Code
V3V1Z2
Country
Canada
Facility Name
Investigational Site Number 124003
City
Toronto
ZIP/Postal Code
M4N3M5
Country
Canada
Facility Name
Investigational Site Number 124002
City
Toronto
ZIP/Postal Code
M5G2M9
Country
Canada
Facility Name
Investigational Site Number 124001
City
Vancouver
ZIP/Postal Code
N5Z4E6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27621395
Citation
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.
Results Reference
derived

Learn more about this trial

Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer

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