Pancreas Neoplasms Clinical Trial
Official title:
A Phase II Study of S-1 in Combination With Gemcitabine and Erlotinib in Patients With Advanced or Metastatic Pancreatic Cancer
Verified date | August 2017 |
Source | Hallym University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will conduct a phase II study of gemcitabine, erlotinib, and S-1 as first-line chemotherapy in patients with advanced pancreatic cancer and evaluate the EGFR expression, KRAS mutation, and BRAF mutation as predictive or prognostic markers
Status | Completed |
Enrollment | 37 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Pathologically confirmed locally advanced unresectable, recurrent or metastatic adenocarcinoma of pancreas (Stage III-IV ; TNM staging system) - Measurable or evaluable disease by RECIST criteria 1.1 - Minimum age of 18 years - ECOG Performance status 0-1 - Prior adjuvant chemotherapy without gemcitabine, erlotinib or S-1 is allowed if more than 4 weeks elapsed since completion of chemotherapy. - More than 4 weeks since completion of prior radiotherapy (measurable or evaluable lesions should be outside the radiation field) - Adequate organ functions - Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital. Exclusion Criteria: - Patients treated previously with gemcitabine, erlotinib, or S-1 as adjuvant chemotherapy. - Patients with CNS metastases - Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding - Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix - Known history of cerebral or leptomeningeal metastases or neurologic disease |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Hallym University Medical Center | Anyang |
Lead Sponsor | Collaborator |
---|---|
Hallym University Medical Center | Jeil Pharmaceutical Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate | Objective response rate will be measured from the rate of complete response (disappearance of disease) and partial response (decrease at least 30% in the sum of the longest diameters of target lesions) by RECIST (response evaluation criteria in solid tumors) guidelines. | 1.5 years | |
Secondary | Progression free survival | Progression free survival time will be measured from the start of study treatment until documented tumor progression, or death due to any cause | 1.5 years | |
Secondary | Overall survival | Overall survival time will be measured from the start of study treatment until death due to any cause | 1.5 years | |
Secondary | Disease control rate | Disease control rate will be measured from the rate of complete response (disappearance of disease), partial response (decrease at least 30% in the sum of the longest diameters of target lesions), and stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) by RECIST (response evaluation criteria in solid tumors) guidelines. | 1.5 years | |
Secondary | Toxicity profiles | Adverse events will be descripted and graded using NCI-CTCAE version 4.0 | 1.5 years |
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