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

This study has been withdrawn prior to enrollment.
(due to strong side effect)
Sponsor:
Collaborator:
Hokkaido University Hospital
Information provided by:
Hokkaido Gastrointestinal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00209612
First received: September 13, 2005
Last updated: February 16, 2009
Last verified: February 2009
History of Changes
  Purpose

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 Intervention Phase
Gastric Cancer
 Drug: Taxol
Drug: Campt, Topotesin
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hokkaido Gastrointestinal Cancer Study Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 40
Study Start Date: April 2004
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Paclitaxel+Irinotecan
 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

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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209612

Locations
Japan
・ 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
Investigators
Study Chair: Masahiro Asaka, MD, PhD Hokkaido Gastrointestinal Cancer Study Group
  More Information

No publications provided

Responsible Party: Yoshito Komatsu / A vice-director, Associate Prof., Hokkaido University Hospital Cancer Center
ClinicalTrials.gov Identifier: NCT00209612     History of Changes
Other Study ID Numbers: HGCSG0402, PacIri
Study First Received: September 13, 2005
Last Updated: February 16, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Irinotecan
Tubulin Modulators
Antimitotic Agents
 Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013