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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00209612
Recruitment Status : Withdrawn (due to strong side effect)
First Posted : September 21, 2005
Last Update Posted : February 17, 2009
Hokkaido University Hospital
Information provided by:
Hokkaido Gastrointestinal Cancer Study Group

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
Gastric Cancer Drug: Taxol Drug: Campt, Topotesin 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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).
Study Start Date : April 2004
Estimated Primary Completion Date : November 2008
Estimated Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: 1
Drug: Taxol
Day1,15 X mg/m2, IV (in the vein)
Other Name: Paclitaxel

Drug: Campt, Topotesin
Day1,15 Y mg/m2, IV (in the vein)
Other Name: irinotecan

Primary Outcome Measures :
  1. 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. [ Time Frame: 1-year ]

Secondary Outcome Measures :
  1. Determine the clinical response rate of patients in Phase I setting. [ Time Frame: 1-year ]
  2. Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting. [ Time Frame: 2-years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00209612

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・ 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
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Study Chair: Masahiro Asaka, MD, PhD Hokkaido Gastrointestinal Cancer Study Group

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Responsible Party: Yoshito Komatsu / A vice-director, Associate Prof., Hokkaido University Hospital Cancer Center Identifier: NCT00209612    
Other Study ID Numbers: HGCSG0402
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: February 17, 2009
Last Verified: February 2009
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors