Clinical trial NCT01121848: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-05-12
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Within the 3 months of study treatment
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: 12 weeks
measure: Duration of response
timeFrame: 12 weeks
measure: Disease Controlled Rate (DCR)
timeFrame: 12 weeks
measure: Median Overall Survival (OS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Abbotsford
country: Canada
facility: Investigational Site Number 124015
city: Brampton
country: Canada
facility: Investigational Site Number 124018
city: Burnaby
country: Canada
facility: Investigational Site Number 124014
city: Calgary
country: Canada
facility: Investigational Site Number 124006
city: Greenfield Park
country: Canada
facility: Investigational Site Number 124011
city: Hamilton
country: Canada
facility: Investigational Site Number 124010
city: New Glasgow
country: Canada
facility: Investigational Site Number 124-016
city: Oshawa
country: Canada
facility: Investigational Site Number 124013
city: Ottawa
country: Canada
facility: Investigational Site Number 124012
city: Sherbrooke
country: Canada
facility: Investigational Site Number 124004
city: Sudbury
country: Canada
facility: Investigational Site Number 124008
city: Surrey
country: Canada
facility: Investigational Site Number 124007
city: Toronto
country: Canada
facility: Investigational Site Number 124003
city: Toronto
country: Canada
facility: Investigational Site Number 124002
city: Vancouver
country: Canada
facility: Investigational Site Number 124001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
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.