Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Gemcitabine and S-1 Refractory Pancreatic Cancer

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is a randomized, open-label, controlled study that will compare the efficacy of oxaliplatin in combination with irinotecan to irinotecan alone as second-line treatment for patients with gemcitabine and S-1 refractory pancreatic cancer.

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

Details

• Lead Sponsor: Zhejiang University
• Treatments: Camptothecin; Gemcitabine; Irinotecan; Oxaliplatin

Criteria

Inclusion Criteria:

• Patients with histologically confirmed advanced pancreatic cancer who had experienced progression during first-line gemcitabine and S-1 were eligible for enrollment on this open-label, randomized study.

• Additional inclusion criteria were age 18 years or older

• Measurable reference cancer site(s) confirmed with computed tomography (CT) or magnetic resonance imaging (MRI)

• Karnofsky performance status (KPS) of at least 70%

• -Adequate renal function, adequate hepatic function, adequate bone marrow function

Exclusion Criteria:

• The presence of any severe concomitant disease that could interrupt the planned treatment; intractable pain

• Hypersensitivity to study drugs

• Serious cardiovascular disease (eg, unstable coronary artery disease or myocardial infarction within 4 weeks of study start)

• National Cancer Institute CommonToxicity Criteria grade 3 or 4 sensory or motor neuropathy

• Prior or concurrent malignancy (other than pancreatic cancer)

• Female, pregnancy or breastfeeding.