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

Hokkaido Gastrointestinal Cancer Study Group

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Gastric Cancer

Treatments

Drug: Taxol

Drug: Campt, Topotesin

Study type

Interventional

Funder types

Other

Identifiers

NCT00209612

HGCSG0402

PacIri

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

Under 75 years old

Volunteers

No Healthy Volunteers

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