Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer

NCT ID: NCT01121848

Last Updated: 2014-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-10-31

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.

Conditions

Pancreatic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Leucovorin

Intervention Type: DRUG

Pharmaceutical form:vials of 50 mg/5 mL or 500 mg/50mL Route of administration: IV

Dose regimen:

5-Fluorouracil

Intervention Type: DRUG

Pharmaceutical form: vials of 5 g/100mL Route of administration: IV

Dose regimen:

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.

Group Type: EXPERIMENTAL

Leucovorin

Intervention Type: DRUG

Pharmaceutical form:vials of 50 mg/5 mL or 500 mg/50mL Route of administration: IV

Dose regimen:

OXALIPLATIN

Intervention Type: DRUG

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

Intervention Type: DRUG

Pharmaceutical form: vials of 5 g/100mL Route of administration: IV

Dose regimen:

Interventions

Leucovorin

Pharmaceutical form:vials of 50 mg/5 mL or 500 mg/50mL Route of administration: IV

Dose regimen:

Intervention Type: 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:

Intervention Type: DRUG

5-Fluorouracil

Pharmaceutical form: vials of 5 g/100mL Route of administration: IV

Dose regimen:

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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 124008

Greater Sudbury, , 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 124007

Surrey, , Canada

Investigational Site Number 124003

Toronto, , Canada

Investigational Site Number 124002

Toronto, , Canada

Investigational Site Number 124001

Vancouver, , Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 27621395 (View on PubMed)

Other Identifiers

U1111-1116-9746

Identifier Type: OTHER

Identifier Source: secondary_id

OXALI_L_04918

Identifier Type: -

Identifier Source: org_study_id