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

February 16, 2009 updated by: Hokkaido Gastrointestinal Cancer Study Group

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).

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8638
        • ・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Paclitaxel+Irinotecan
Drug: Taxol
Day1,15 X mg/m2, IV (in the vein)
Other Names:
  • Paclitaxel
Drug: Campt, Topotesin
Day1,15 Y mg/m2, IV (in the vein)
Other Names:
  • irinotecan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1-year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hokkaido Gastrointestinal Cancer Study Group

Collaborators

Hokkaido University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Anticipated)

November 1, 2008

Study Completion (Anticipated)

March 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

February 17, 2009

Last Update Submitted That Met QC Criteria

February 16, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGCSG0402
  • PacIri

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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