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

Zhejiang University

Status and phase: Completed; Phase 2

Conditions: Pancreatic Neoplasms

Treatments: Drug: Irinotecan; Drug: Oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02558868

ZYYYMedOncoPAC02

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Oxaliplatin + Irinotecan

Experimental group

Description:

Irinotecan：160 mg/m2，iv 120 min，d1 q2w oxaliplatin: 85 mg/m2，iv 120 min，d1 q2w

Treatment:

Drug: Irinotecan

Drug: Oxaliplatin

Irinotecan

Active Comparator group

Description:

Irinotecan：180 mg/m2，iv 120 min，d1 q2w

Treatment:

Drug: Irinotecan