Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00209612
Other study ID # HGCSG0402
Secondary ID PacIri
Status Withdrawn
Phase Phase 1/Phase 2
First received September 13, 2005
Last updated February 16, 2009
Start date April 2004
Est. completion date March 2009

Study information

Verified date February 2009
Source Hokkaido Gastrointestinal Cancer Study Group
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 40
Est. completion date March 2009
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group N/A to 75 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Taxol
Day1,15 X mg/m2, IV (in the vein)
Campt, Topotesin
Day1,15 Y mg/m2, IV (in the vein)

Locations

Country Name City State
Japan · Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine) Sapporo Hokkaido

Sponsors (2)

Lead Sponsor Collaborator
Hokkaido Gastrointestinal Cancer Study Group Hokkaido University Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1-year Yes
Secondary Determine the clinical response rate of patients in Phase I setting. 1-year Yes
Secondary Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting. 2-years Yes
See also
  Status Clinical Trial Phase
Recruiting NCT05551416 - The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer
Completed NCT05518929 - Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients Phase 4
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03219593 - Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT05536102 - The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy) Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Recruiting NCT05415098 - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas Phase 1
Active, not recruiting NCT04082364 - Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer Phase 2/Phase 3
Withdrawn NCT03766607 - Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer Phase 2
Recruiting NCT04118114 - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors Phase 2
Completed NCT01924533 - Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer. Phase 3
Terminated NCT01641939 - A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer Phase 2/Phase 3
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Active, not recruiting NCT04908813 - Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer Phase 2
Active, not recruiting NCT04249739 - Pembrolizumab + Capecitabine/Oxaliplatin (CapeOx) -HER2 Nagative and Pembrolizumab + Trastuzumab + Cisplatin/Capecitabine HER2 Positive Phase 2
Recruiting NCT05514158 - To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 in the Treatment of Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer (Including AEG) Phase 1
Recruiting NCT04931654 - A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer Phase 1/Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2