Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer

Pancreatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121848
• Other study ID #: OXALI_L_04918
• Secondary ID: U1111-1116-9746
• Status: Completed
• Phase: Phase 3
• First received: April 29, 2010
• Last updated: October 23, 2014
• Start date: July 2010
• Est. completion date: October 2013

Study information

• Verified date: October 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Drug:
• Leucovorin
Pharmaceutical form:vials of 50 mg/5 mL or 500 mg/50mL Route of administration: IV Dose regimen:
• 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:
• 5-Fluorouracil
Pharmaceutical form: vials of 5 g/100mL Route of administration: IV Dose regimen:

Locations

Country	Name	City	State
Canada	Investigational Site Number 124015	Abbotsford
Canada	Investigational Site Number 124018	Brampton
Canada	Investigational Site Number 124014	Burnaby
Canada	Investigational Site Number 124006	Calgary
Canada	Investigational Site Number 124011	Greenfield Park
Canada	Investigational Site Number 124010	Hamilton
Canada	Investigational Site Number 124-016	New Glasgow
Canada	Investigational Site Number 124013	Oshawa
Canada	Investigational Site Number 124012	Ottawa
Canada	Investigational Site Number 124004	Sherbrooke
Canada	Investigational Site Number 124008	Sudbury
Canada	Investigational Site Number 124007	Surrey
Canada	Investigational Site Number 124002	Toronto
Canada	Investigational Site Number 124003	Toronto
Canada	Investigational Site Number 124001	Vancouver

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Median Overall Survival (OS)	Median Survival is the number of weeks at which 50% of the patients are still alive.	2 years	No