Phase I/II Study of Paclitaxel Plus CPT-11 in Pts. With 2nd Line Chemotherapy of Inoperable or Recurrent GC.
- Registration Number
- NCT00209612
- Lead Sponsor
- Hokkaido Gastrointestinal Cancer Study Group
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Campt, Topotesin Paclitaxel+Irinotecan 1 Taxol Paclitaxel+Irinotecan
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting. 2-years Determine the clinical response rate of patients in Phase I setting. 1-year
Trial Locations
- Locations (1)
・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)
🇯🇵Sapporo, Hokkaido, Japan