Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer

NCT01121848 | Completed Phase 3

• 2 other identifiers: OXALI_L_04918U1111-1116-9746
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 15

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Overall response rate (ORR)

  12 weeks

• Duration of response

  12 weeks

• Disease Controlled Rate (DCR)

  12 weeks

• Median Overall Survival (OS)

  2 years

Study Arms (2)

5-FU & LV

ACTIVE COMPARATOR

* 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.

Drug: Leucovorin; Drug: 5-Fluorouracil

XELOX or modified FOLFOX-6

EXPERIMENTAL

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.

Drug: Leucovorin; Drug: OXALIPLATIN; Drug: 5-Fluorouracil

Interventions

Leucovorin DRUG

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

5-FU & LV; XELOX or modified FOLFOX-6

OXALIPLATIN 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:

XELOX or modified FOLFOX-6

5-Fluorouracil DRUG

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

5-FU & LV; XELOX or modified FOLFOX-6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (15)

Investigational Site Number 124015

Abbotsford, V2S0C2, Canada

Location

Investigational Site Number 124018

Brampton, L6V1B4, Canada

Location

Investigational Site Number 124014

Burnaby, V5G2X6, Canada

Location

Investigational Site Number 124006

Calgary, T2N 4N2, Canada

Location

Investigational Site Number 124008

Greater Sudbury, P3E5J1, Canada

Location

Investigational Site Number 124011

Greenfield Park, J4V2H1, Canada

Location

Investigational Site Number 124010

Hamilton, L8V5C2, Canada

Location

Investigational Site Number 124-016

New Glasgow, Canada

Location

Investigational Site Number 124013

Oshawa, L1G2B9, Canada

Location

Investigational Site Number 124012

Ottawa, K1Y0W9, Canada

Location

Investigational Site Number 124004

Sherbrooke, J1H 5N4, Canada

Location

Investigational Site Number 124007

Surrey, V3V1Z2, Canada

Location

Investigational Site Number 124003

Toronto, M4N3M5, Canada

Location

Investigational Site Number 124002

Toronto, M5G2M9, Canada

Location

Investigational Site Number 124001

Vancouver, N5Z4E6, Canada

Location

Related Publications (1)

• 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.

  PMID: 27621395 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Leucovorin; Oxaliplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: May 12, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 27, 2014

Record last verified: 2014-10

Locations

CA (15)