Phase I/II Study of Paclitaxel Plus CPT-11 in Pts. With 2nd Line Chemotherapy of Inoperable or Recurrent GC.

• Status: Withdrawn
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hokkaido Gastrointestinal Cancer Study Group
• Collaborator: Hokkaido University Hospital
• Treatments: Albumin-Bound Paclitaxel; Irinotecan; Paclitaxel

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

• 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