Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Neoplasms

Thank you

Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Description:

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

Outcome Time Frame:

Within the 3 months of study treatment

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Canada: Health Canada

Study ID:

OXALI_L_04918

NCT ID:

NCT01121848

Start Date:

June 2010

Completion Date:

November 2013

Related Keywords:

  • Pancreatic Neoplasms
  • Neoplasms
  • Pancreatic Neoplasms

Name

Location