Phase II study of gemcitabine plus oxaliplatin combination therapy (GEMOX therapy) for the advanced pancreatic adenocarcinoma with a family history of pancreatic/breast/ovarian/prostate cancer or with a personal history of breast/ovarian/prostate cancer.

Phase 2

• Conditions: Metastatic pancreatic cancer patients with a family history of pancreatic/breast/ovarian/prostate cancer or with a personal history of breast/ovarian/prostate cancer.

• Registration Number: JPRN-UMIN000017894
• Lead Sponsor: ational Cancer Center Hospital

Brief Summary

Among the first 43 enrolled patients, the 1-year survival rate was 27.9% (90% CI 17.0-41.3). This trial did not meet its primary endpoint because the lower limit of the 90% CI was lower than the prespecified threshold of 30%.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-17
• Study Completion: 2019-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

1) Synchronous or metachronous (within 3 years) malignancies except carcinoma in situ or intramucosal tumor curatively treated with local therapy 2) Known metastasis to the central nervus system 3) Presence of uncontrollable moderate or severe ascites and/or pleural effusion 4) Grade 2 or more of peripheral sensory neuropathy or peripheral motor neuropathy 5) Oral intake is impossible 6) Major surgery within 4 weeks 7) Blood transfusion or G-CSF within 2 weeks 8) Patients requiring systemic steroids medication 9) Unstable angina pectoris within 3 weeks, or with a history of myocardial infarction within 6 months 10) Interstitial pneumonia, pulmonary fibrosis 11) Severe complications such as heart failure, renal failure, liver failure, peptic ulcer with active bleeding, intestinal paralysis, uncontrolled diabetes mellitus, etc 12) Active infection requiring systemic therapy 13) Pregnant or lactating women or women of childbearing potential, Male expecting partner's pregnancy 14) Psychosis or severe mental disorder 15) History of sever allergic reaction to gemcitabine or oxaliplatin 16) Impossible to use both iodine and gadolinium due to being allergic to contrast agent 17) Inadequate physical condition, as diagnosed by attending physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1-year survival rate

Secondary Outcome Measures

Name	Time	Method
Overall survival, Progression-free survival, response rate, adverse events