Gastric Cancer
Conditions
Brief summary
A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using CPT-11 and Paclitaxel in pre-treated patients with metastatic gastric cancer. The usefulness of the this regimen is evaluated by response rate, median survival time, and progression free survival.
Detailed description
Patients with pre-treated measurable metastatic gastric cancer were included in this trial. Patients received this combination chemotherapy repeated every 28 days until progression disease. Starting dose (dose level 1) were CPT-11 80 mg/m2 on day 1 and 15, Paclitaxel 60 mg/m2 on day 1 and 15. DLT was defined as follows (according to NCI-CTC version 2.0); Grade 4 neutropenia, thrombocytopenia(≥25000), Grade 3 neutropenia accompanied fever (\>38℃) , and Grade 3 non-hematological toxicity (except for nausea, vomit, appetite loss , general fatigue, alopecia). Maximal Tolerated Dose (MTD) is determined when the incidence of critical toxicity exceeds 50% at a certain dose level. Response rate will be calculated according to RECIST criteria.
Interventions
DRUGTaxol
Day1,15 X mg/m2, IV (in the vein)
DRUGCampt, Topotesin
Day1,15 Y mg/m2, IV (in the vein)
Sponsors
Hokkaido University Hospital
Hokkaido Gastrointestinal Cancer Study Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed metastatic or recurrent gastric cancer with prior treatment for advanced disease. * Patients who have received 1cycle cancer therapy (radiotherapy, chemotherapy or chemoradiotherapy) given \> 4 weeks prior to the beginning of study therapy * At least one measurable lesion according to the RECIST criteria. Minimum indicator lesion size: \> 10 mm measured by spiral CT or \>20mm measured by conventional techniques(Except for Phase I setting). * Patients aged between 20 and 75 years, inclusive, at the time of acquisition of informed consent * Patients with performance status(ECOG) 0 to 2 * Abnormal hematologic values (WBC ≥ 3.5 x 109/L, Hemoglobin ≥ 9.0g/dl, platelet count ≥ 100 x 109/L) * Serum cleatinine ≤ 1.5mg/dl * Serum bilirubin ≤ 1.5mg/dl. ALT, AST ≤ 2.0 x upper normal limit (or ≤ 3 x upper normal limit in the case of liver metastases) * Normal ECG * Life expectancy ≥ 3 months * Patients who have given written informed consent to participate in this study
Exclusion criteria
* Patients with active multiple cancers; or even if the multiple cancers are metachronous, have a disease-free period of less than 5 years (but excluding cancer in situ and skin cancer) (Except for Phase I setting) * Serious, uncontrolled, concurrent infection(s) or illness(es) * Patients with no serious concurrent complications (such as heart disease, Intestinal pneumonia) * Patients with Liver cirrhosis * Patients with fresh hemorrhage from the gastrointestinal tract * Patients with poorly controlled diabetes or are treated by continuous use of insulin * Patients with concurrent psychiatric disease or psychotic symptoms, and judged to have difficulties participating in the study * Patients with retention of body fluid(pleural effusion, ascites, pericardial effusion) necessitating treatment * Patients with diarrhea (watery stool) * Patients with infection, intestinal palsy or intestinal occlusion * Patients with brain metastasis * Patients with Gilbert syndrome * Patients who have experienced serious drug allergy in the past * Patients who are pregnant and lactating or hope to become pregnant during the study period * Patients with prior Taxan (Paclitaxel, Docetaxel) or CPT-11 treatment * Patients with neuropathy ≥ grade 2 * Others, patients judged by the investigator or subinvestigator to be inappropriate as subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting. Determine the clinical response rate with Recommended dose in Phase II setting. | 1-year |
Secondary
| Measure | Time frame |
|---|---|
| Determine the clinical response rate of patients in Phase I setting. | 1-year |
| Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting. | 2-years |
Countries
Japan
Outcome results
None listed