Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer

Sanofi

Status and phase: Completed; Phase 3

Conditions: Pancreatic Neoplasms

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01121848

U1111-1116-9746 (Other Identifier)

OXALI_L_04918

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

108 participants in 2 patient groups

5-FU & LV

Active Comparator group

Description:

* 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.

Treatment:

Drug: Leucovorin

Drug: 5-Fluorouracil

XELOX or modified FOLFOX-6

Experimental group

Description:

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.

Treatment:

Drug: Leucovorin

Drug: OXALIPLATIN

Drug: 5-Fluorouracil