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Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01121848
Recruitment Status : Completed
First Posted : May 12, 2010
Last Update Posted : October 27, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE April 29, 2010
First Posted Date  ICMJE May 12, 2010
Last Update Posted Date October 27, 2014
Study Start Date  ICMJE July 2010
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01121848 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2010)
  • 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).
  • 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
  • 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)
  • Median Overall Survival (OS) [ Time Frame: 2 years ]
    Median Survival is the number of weeks at which 50% of the patients are still alive.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Neoplasms
Intervention  ICMJE
  • 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:

Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Leucovorin
    • Drug: 5-Fluorouracil
  • 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.
    Interventions:
    • Drug: Leucovorin
    • Drug: OXALIPLATIN
    • Drug: 5-Fluorouracil
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2014)
108
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2010)
128
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01121848
Other Study ID Numbers  ICMJE OXALI_L_04918
U1111-1116-9746 ( Other Identifier: UTN )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP