Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer - Full Text View

Purpose

Primary Objective:

To demonstrate that the addition of oxaliplatin to 5-Fluorouracil (5-FU) and Leucovorin (LV) or Capecitabine 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's responses and safety.

Condition	Intervention	Phase
Pancreatic Neoplasms	Drug: Leucovorin Drug: OXALIPLATIN Drug: Capecitabine Drug: 5-Fluorouracil	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Phase III Study of Capecitabine or 5-Fluorouracil-based Regimen With or Without Oxaliplatin as 2nd Line Treatment of Advanced Pancreatic Cancer in Patients Who Have Previously Received Gemcitabine-based Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Fluorouracil Leucovorin calcium Oxaliplatin Levoleucovorin Capecitabine

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

Progression-Free Survival (PFS) [ Time Frame: Within the 3 months of study treatment ] [ Designated as safety issue: No ]
PFS is defined as the time from the start of treatment to the date of disease progression or death from any cause.

Secondary Outcome Measures:

Overall response rate (ORR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Median Survival is the number of weeks at which 50% of the patients are still alive.

Estimated Enrollment:	128
Study Start Date:	June 2010
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Capecitabine or 5-FU & LV - Day 1: Capecitabine 1000 mg/m2 PO twice a day for 14 days every three weeks OR: 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 Pharmaceutical form:vials of 50 mg/5 mL or 500 mg/50mL Route of administration: IV Dose regimen: Drug: Capecitabine Pharmaceutical form: Tablet Route of administration: PO Dose regimen: Drug: 5-Fluorouracil Pharmaceutical form: vials of 5 g/100mL Route of administration: IV Dose regimen:
Experimental: XELOX or modified FOLFOX-6 XELOX: Day 1: Oxaliplatin 130 mg/m2 (2 hours infusion) Day 1: Capecitabine 1000 mg/m2 PO twice a day for 14 days 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 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: Capecitabine Pharmaceutical form: Tablet Route of administration: PO Dose regimen: Drug: 5-Fluorouracil Pharmaceutical form: vials of 5 g/100mL Route of administration: IV Dose regimen:

Arms

Assigned Interventions

Active Comparator: Capecitabine or 5-FU & LV

- Day 1: Capecitabine 1000 mg/m2 PO twice a day for 14 days every three weeks

OR:

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

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

Dose regimen:

Drug: Capecitabine

Pharmaceutical form: Tablet Route of administration: PO

Dose regimen:

Drug: 5-Fluorouracil

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

Dose regimen:

Experimental: XELOX or modified FOLFOX-6

XELOX:

Day 1: Oxaliplatin 130 mg/m2 (2 hours infusion)
Day 1: Capecitabine 1000 mg/m2 PO twice a day for 14 days
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

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: Capecitabine

Pharmaceutical form: Tablet Route of administration: PO

Dose regimen:

Drug: 5-Fluorouracil

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

Dose regimen:

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 capecitabine, 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121848

Locations

Canada
Investigational Site Number 124015
Abbotsford, Canada, V2S0C2
Investigational Site Number 124018
Brampton, Canada, L6V1B4
Investigational Site Number 124014
Burnaby, Canada, V5G2X6
Investigational Site Number 124006
Calgary, Canada, T2N 4N2
Investigational Site Number 124011
Greenfield Park, Canada, J4V2H1
Investigational Site Number 124010
Hamilton, Canada, L8V5C2
Investigational Site Number 124-016
New Glasgow, Canada
Investigational Site Number 124013
Oshawa, Canada, L1G2B9
Investigational Site Number 124012
Ottawa, Canada, K1Y0W9
Investigational Site Number 124004
Sherbrooke, Canada, J1H 5N4
Investigational Site Number 124008
Sudbury, Canada, P3E5J1
Investigational Site Number 124007
Surrey, Canada, V3V1Z2
Investigational Site Number 124002
Toronto, Canada, M5G2M9
Investigational Site Number 124003
Toronto, Canada, M4N3M5
Investigational Site Number 124001
Vancouver, Canada, N5Z4E6

Sponsors and Collaborators

Sanofi

Investigators

Study Director:

Clinical Sciences & Operations

Sanofi

More Information

No publications provided

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT01121848 History of Changes
Other Study ID Numbers:	OXALI_L_04918, U1111-1116-9746
Study First Received:	April 29, 2010
Last Updated:	February 28, 2013
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Fluorouracil
Capecitabine
Oxaliplatin
Leucovorin
Levoleucovorin
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on May 21, 2013