Fluorouracil and Oxaliplatin as First-line for Advanced Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with locally advanced or metastatic pancreatic adenocarcinoma not eligible for infusional fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX) (PPS 2 or hyperbilirubinemia, among other causes) will be treated with mFLOX regimen (fluorouracil bolus and oxaliplatin). The primary endpoint is to assess the objective response rate according to RECIST criteria (version 1.1) and the secondary endpoints are time until clinical or radiological progression, overall survival, toxicity profile.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto do Cancer do Estado de São Paulo
• Treatments: Fluorouracil; Oxaliplatin

Criteria

Inclusion Criteria:

• Patients with pancreatic adenocarcinoma, confirmed by biopsy and histological material available for review

• Unresectable primary tumor considered by the team assistant or metastatic disease

• Aged between 18 and 75 at the time of study entry

• Naïve patients of palliative chemotherapy, admitted for treatment at the Institute of the São Paulo State Cancer (ICESP)

• Patients with performance status 0 or 1, not candidates to receive chemotherapy with FOLFIRINOX or performance status 2.

• No significant organ dysfunction defined as: Hb> 9 g / dL, platelets> 100,000 / microliter (mcL), neutrophils> 1500 / mcL, clearance of creatinine (ClCr) > 50 ml / min, total bilirubin <5 mg/dl, serum alanine transaminase (ALT) and aspartate transaminase (AST) <2.5 x upper limit of normal (ULN) (or <5 x ULN if liver metastases present)

• Able to read and sign an informed consent form.

Exclusion Criteria:

• Use of prior chemotherapy with other agents, except adjuvant chemotherapy with gemcitabine monotherapy since completed more than 6 months

• Absence of histological material available to local review (eg diagnostic fine needle aspiration (FNA) or cytology)

• Previous use of radiotherapy in the primary tumor or a metastasis site that will serve as target lesion to assess response to treatment

• Diagnosis of malignancy other activity except non-melanoma skin cancer

• Clinical evidence of metastasis in the central nervous system active meningeal carcinomatosis or severe chronic disease patients (cirrhosis, heart failure New York Heart Association Functional Classification (NYHA) III or IV, chronic obstructive pulmonary disease (COPD) oxygen-dependent or chronic kidney disease requiring dialysis)

• Pregnant or breastfeeding

• Patients with HIV / AIDS story on anti-retroviral therapy

• Patients with peripheral neuropathy grade> 2 (CTCAE v4.03)

• Medium or large surgery in the last 4 weeks. For example, biliary derivation.