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

Sponsors and Collaborators:	Hokkaido Gastrointestinal Cancer Study Group Hokkaido University Hospital
Information provided by:	Hokkaido Gastrointestinal Cancer Study Group
ClinicalTrials.gov Identifier:	NCT00209612

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Paclitaxel Irinotecan U 101440E Irinotecan hydrochloride

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
1: Experimental Paclitaxel+Irinotecan	Drug: Taxol Day1,15 X mg/m2, IV (in the vein) Drug: Campt, Topotesin Day1,15 Y mg/m2, IV (in the vein)

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

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Irinotecan
Antimitotic Agents
Recurrence
Digestive System Diseases
Stomach Diseases

Paclitaxel
Stomach Neoplasms
Tubulin Modulators
Gastrointestinal Neoplasms
Stomach Cancer
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:

Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site

Digestive System Diseases
Stomach Diseases
Paclitaxel
Therapeutic Uses
Stomach Neoplasms
Tubulin Modulators
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on August 30, 2009