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

Zhejiang University logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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