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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000101 |
Receipt No. | R000000149 |
Scientific Title | A phase I/II study of weekly paclitaxel therapy for metastatic gastric cancer (Step 2) |
Date of disclosure of the study information | 2005/10/01 |
Last modified on | 2008/09/01 |
Basic information | ||
Public title | A phase I/II study of weekly paclitaxel therapy for metastatic gastric cancer (Step 2) | |
Acronym | A phase II study of paclitaxel weekly administration for metastatic gastric cancer | |
Scientific Title | A phase I/II study of weekly paclitaxel therapy for metastatic gastric cancer (Step 2) | |
Scientific Title:Acronym | A phase II study of paclitaxel weekly administration for metastatic gastric cancer | |
Region |
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Condition | ||
Condition | Fluoropyrimidine failure metastatic gastric cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | YES |
Objectives | |
Narrative objectives1 | To evaluate the efficacy and safety of weekly 90 mg/m2 paclitaxel administration for fluoropyrimidine-resistant metastatic gastric cancer patients, and identify the possible biomarkers |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Explanatory |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | 1)Tumor response rate
2)Genotype-phenotype association (CYP3A4 and CYP2C8 vs toxicity), and expression-phenotype association (MDR1 and TUBB vs tumor response) |
Key secondary outcomes | 1)Adverse events,
2)Progression free-survival (PFS) 3)Overall survival (OS) 4)Genotype-phenotype association (CYP3A4 and CYP2C8 vs PK parameter) 5) Gene expression-phenotype association (MDR1 and TUBB vs PK parameter) 6) Possible pharmacogenomic factors other than CYP3A4, CYP2C8, MDR1, and TUBB |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Intravenous administration of paclitaxel 90 mg/m2 on Days 1, 8, and 15, every 4 weeks | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | (1)With pathologically proven gastric cancer
(2)With advanced gastric cancer resistant to fluoropyrimidines (up to 1 prior regimen other than fluoropyrimidines-based therapy) (3)With at least one measurable lesion (RECIST) (4)With adequate bone marrow, cardiac, respiratory, hepatic, and renal functions. Defined as: white blood cell count>=4000 mm3, neutrophil count>=2000 mm3, hemoglobin>=9.0 g/dl, platelet>=100,000 mm3, AST and ALT within two times the upper limit of normal for the institution, serum bilirubin level<=1.5 mg/dl, BUN<=25 mg/dl, serum creatinine level<=1.5 mg/dl, creatinine clearance>=50 ml/min., C-reactive protein <=1.0 mg/dl, normal ECG (5)ECOG performance status<=2 (6)Prior chemotherapy was completed>=28 days prior to entry (7)Life expectancy estimated>=12 weeks (8)Age 20-75 years (9)With collected tissue samples for pharmacogenomic analysis (10)With written informed consent |
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Key exclusion criteria | (1)With other serious disease:
Ischemic heart disease, arrhythmia, Myocardiac infarction occurred within 6 month,Liver cirrhosis, Hemorrhage/bleeding>=grade3(NCI-CTC),Symptomatic psychological disease, Uncontrollable diabetes, Obstructive bowel disease (2)Active secondary cancer (3)A past history of drug allergy (4)A past history of allergic reaction to polyoxy-ethilen oil (5)Prior chemotherapy including a taxane (6)Peripheral neuropathy>=grade 2 in prior chemotherapy (7)Pregnancy or breast feeding (8)Ineligible decision by principal investigator (9)Active hepatitis or syphilis |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Research Institute for Radiation Biology and Medicine, Hiroshima University | ||||||
Division name | Department of Translational Cancer Research | ||||||
Zip code | |||||||
Address | 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan | ||||||
TEL | 082-257-5839 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Research Institute for Radiation Biology and Medicine, Hiroshima University | ||||||
Division name | Department of Translational Cancer Research | ||||||
Zip code | |||||||
Address | 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan | ||||||
TEL | 082-257-5839 | ||||||
Homepage URL | http://www.hictdo.or.jp/tiken.html | ||||||
yamacho@hiroshima-u.ac.jp |
Sponsor | |
Institute | Hiroshima Cancer Therapy Development Organization (HiCTDO) |
Institute | |
Department |
Funding Source | |
Organization | Hiroshima Cancer Therapy Development Organization (HiCTDO) |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | Hiroshima Univ., Iwate Med. Univ.,Toyosu Hosp., Showa Univ., Kanagawa Cancer Ctr Hosp., Grad. Sch. Med., Hokkaido Univ., Kawakita Hosp., Grad. Sch. Med., Kobe Univ.
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Name of secondary funder(s) | None |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | HiCTDO protocol #1 |
Org. issuing International ID_1 | Hiroshima Cancer Therapy Development Organization (HiCTDO) |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | http://www.hictdo.or.jp/tiken.html |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | Paper is being prepared (Sep. 1/2008) |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | Step 1 (phase I) has been completed.
(http://www.asco.org/ac/1,1003_12- 002636-00_18-0026-00_19-003091, 00.asp) |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000149 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |