Status:
WITHDRAWN
Phase I/II Study of Paclitaxel Plus CPT-11 in Pts. With 2nd Line Chemotherapy of Inoperable or Recurrent GC.
Lead Sponsor:
Hokkaido Gastrointestinal Cancer Study Group
Collaborating Sponsors:
Hokkaido University Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE1
PHASE2
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 patie...
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00209612
Start Date
April 1 2004
End Date
March 1 2009
Last Update
February 17 2009
Active Locations (1)
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1
・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)
Sapporo, Hokkaido, Japan, 060-8638