Phase I/II Study of Paclitaxel Plus CPT-11 in Pts. With 2nd Line Chemotherapy of Inoperable or Recurrent GC.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Paclitaxel+Irinotecan |
Drug: Taxol
Day1,15 X mg/m2, IV (in the vein)
Other Names:
Drug: Campt, Topotesin
Day1,15 Y mg/m2, IV (in the vein)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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
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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).
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Patients aged between 20 and 75 years, inclusive, at the time of acquisition of informed consent
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Patients with performance status(ECOG) 0 to 2
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Abnormal hematologic values (WBC ≥ 3.5 x 109/L, Hemoglobin ≥ 9.0g/dl, platelet count ≥ 100 x 109/L)
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Serum cleatinine ≤ 1.5mg/dl
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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)
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Normal ECG
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Life expectancy ≥ 3 months
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Patients who have given written informed consent to participate in this study
Exclusion Criteria:
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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)
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Serious, uncontrolled, concurrent infection(s) or illness(es)
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Patients with no serious concurrent complications (such as heart disease, Intestinal pneumonia)
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Patients with Liver cirrhosis
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Patients with fresh hemorrhage from the gastrointestinal tract
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Patients with poorly controlled diabetes or are treated by continuous use of insulin
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Patients with concurrent psychiatric disease or psychotic symptoms, and judged to have difficulties participating in the study
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Patients with retention of body fluid(pleural effusion, ascites, pericardial effusion) necessitating treatment
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Patients with diarrhea (watery stool)
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Patients with infection, intestinal palsy or intestinal occlusion
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Patients with brain metastasis
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Patients with Gilbert syndrome
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Patients who have experienced serious drug allergy in the past
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Patients who are pregnant and lactating or hope to become pregnant during the study period
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Patients with prior Taxan (Paclitaxel, Docetaxel) or CPT-11 treatment
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Patients with neuropathy ≥ grade 2
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Others, patients judged by the investigator or subinvestigator to be inappropriate as subject
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine) | Sapporo | Hokkaido | Japan | 060-8638 |
Sponsors and Collaborators
- Hokkaido Gastrointestinal Cancer Study Group
- Hokkaido University Hospital
Investigators
- Study Chair: Masahiro Asaka, MD, PhD, Hokkaido Gastrointestinal Cancer Study Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HGCSG0402
- PacIri