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Phase I/II Study of Biweekly Administration Regimen of Paclitaxel Combined With CPT-11 in Patients With Second Line Chemotherapy of Inoperable or Recurrent Gastric Cancer(GC).

Phase 1/Phase 2
75 Years
Not Enrolling
Gastric Cancer

Thank you

Trial Information

Phase I/II Study of Biweekly Administration Regimen of Paclitaxel Combined With CPT-11 in Patients With Second Line Chemotherapy of Inoperable or Recurrent Gastric Cancer(GC).

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.

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Masahiro Asaka, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hokkaido Gastrointestinal Cancer Study Group


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

April 2004

Completion Date:

March 2009

Related Keywords:

  • Gastric Cancer
  • Stomach Neoplasms