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Completed

NCT Number: NCT01121848

Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number 124015, Abbotsford British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Leucovorin

Drug

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

Dose regimen:

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:

5-fluorouracil

Drug

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

Dose regimen:

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Within the 3 months of study treatment

    PFS is defined as the time from the start of treatment to the date of disease progression or death from any cause.

Secondary outcomes

  1. Overall response rate (ORR)

    Time frame: 12 weeks

    ORR is based on RECIST criteria and is the percentage of patients with complete response (CR) or partial response (PR).

  2. Duration of response

    Time frame: 12 weeks

    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

  3. Disease Controlled Rate (DCR)

    Time frame: 12 weeks

    DCR is also based on RECIST criteria and is defined as the percentage of patients who have a CR, PR or stable disease (SD)

  4. Median Overall Survival (OS)

    Time frame: 2 years

    Median Survival is the number of weeks at which 50% of the patients are still alive.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 12, 2010
Registry last updated
Oct 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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