Stomach Neoplasms
Conditions
Brief summary
1.Study rationale:There is no standard regimen for the advanced and/or metastatic gastric cancer patients who relapsed after adjuvant chemotherapy or failed to first systemic chemotherapy. 2.Primary Objectives:To evaluate overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria and To investigate time to response 3.Design:single-center, Open label, Phase II study. docetaxel 75mg/m2 administered on day 1 as intravenously combined with intravenous Epirubicin 60mg/m2 given day 2 every 3 weeks. 4.Primary endpoints: 1. Efficacy:overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria, time to response, duration of response, and time to treatment failure. 2. Safety-Adverse events and laboratory tests, graded according to the NCI Common Toxicity Criteria for Adverse Effects (version 3.0).
Interventions
Sponsors
Yonsei University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female outpatients ≥ 18 years, * Eastern Cooperative Oncology Group performance status below 1, with histologically confirmed as gastric adenocarcinoma with inoperable and/or metastatic disease. * Patients must have at least one target lesion with a minimum lesion size as per the Response Evaluation Criteria in Solid Tumors criteria (at least 1 unidimensional measurable lesion ≥ 20 mm in diameter by conventional CT or MRI scan, or ≥ 10 mm in diameter by spiral CT scan). * Creatinine clearance ≥ 60ml/min (estimated creatinine clearance must be calculated at baseline for all patients.) * Adequate major organ function : - Hematopoietic function: white blood cell \>4,000/mm3 or absolute neutrophil count \> 2,000/mm3, Platelet count ≥ 100,000/mm3,- Hepatic function: Bilirubin \< 1.5 X upper normal limit, aspartate aminotransferase/alanine aminotransferase levels \<2.5 X upper normal limit, alkaline phosphatase \< 5 x upper normal limit (except in case of bone metastasis without any liver disease) - Renal function: Creatinine \<1 x upper normal limit or creatinine clearance ≥ 60ml/min.
Exclusion criteria
* Patients must not have previously received systemic treatment (cytotoxic chemotherapy or active/passive immunotherapy) for advanced or metastatic disease. * Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment. * The following laboratory values: - neutrophils ≤1.5 X 109 /L, platelet count\<100 X 109 /L- serum bilirubin ≥ 1.5 X upper normal limit, aspartate aminotransferase , alanine aminotransferase \> 2.5 X upper normal limit or \> 5 X upper normal limit in the case of liver metastases- Alkaline phosphatase \> 2.5 X upper normal limit or 5 X upper normal limit in the case of liver metastases or \> 10 X upper normal limit in the case of bone disease. * Prior therapy with Taxotere or Epirubicin is excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | One year |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | Treatment Group |
|---|---|
| Age, Continuous | 53 years |
| Region of Enrollment Korea, Republic of | 34 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 34 |
| serious Total, serious adverse events | 3 / 34 |
Outcome results
Primary
Overall Survival
Time frame: One year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Group | Overall Survival | 13.4 month |