UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001060 |
|---|---|
| Receipt number | R000001283 |
| Scientific Title | Phase II Study of FOLFIRI Plus Bevacizumab (AVASIRI) in Patients as Second Line Chemotherapy of Unresectable Colorectal Cancer |
| Date of disclosure of the study information | 2008/03/01 |
| Last modified on | 2010/09/03 15:17:41 |
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Basic information
Public title
Phase II Study of FOLFIRI Plus Bevacizumab (AVASIRI) in Patients as Second Line Chemotherapy of Unresectable Colorectal Cancer
Acronym
AVASIRI trial
Scientific Title
Phase II Study of FOLFIRI Plus Bevacizumab (AVASIRI) in Patients as Second Line Chemotherapy of Unresectable Colorectal Cancer
Scientific Title:Acronym
AVASIRI trial
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to determine confirmed objective response rate to combination therapy with bevacizumab plus FOLFIRI on best overall objective response rate by RECIST and safety in the second-line treatment of patients with metastatic colorectal cancer.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Assessment of overall response rate (ORR; complete response [CR] + partial response [PR]).
Key secondary outcomes
Assessment of overall survival (OS), progression free survival. time to treatment failure and safety.
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
| Medicine |
Interventions/Control_1
5-FU, CPT-11, Bevacizumab
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Inoperable, locally advanced and/or metastatic colorectal cancer
2) Histologically confirmed adenocarcinoma, mucinous adenocarcinoma or signet-ring cell carcinoma
3) Age 20 to 75
4) Performance status 0-2(ECOG)
5) Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
6) Have prior chemotherapy as first line treatment
7) No prior CPT-11 and bevacizumab administration
8) Urine dipstick for proteinuria should be<2+
9) Adequate function of major organs as defined below:
Hb >8.0g/dl
WBC 3,000-12,000/ul
Platelet >100,000/ul
Bilirubin <1.5 mg/dL
GOT and GPT <100 IU/L
Creatinine <1.5 mg/dL
10) Voluntary written informed consent
Key exclusion criteria
1) Active double cancer
2) Serious drug hypersensitivity or a history of drug allergy
3) Active infections
4) Serious complications (e.g., intestinal tract paralysis, ileus, pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure or hepatic failure.)
5) Uncontrolled hypertension
6) Abnormal EKG
7) Severe ascites
8) Metastasis to the CNS
9) History or evidence of inherited bleeding diathesis
10) Coagulopathy with the risk of bleeding
11) Patient with a past history of thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
12) HBs Ab positive, HCV At positive
13) Uncontrolled watery diarrhea
14) Major surgical procedure within 4 weeks
15) Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children.
16) Judged ineligible for participation in the study by the investigator for safety reasons.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhide Yamada |
Organization
National Cancer Center Hospital
Division name
Gastrointestinal Oncology Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori Hirashima |
Organization
National Cancer Center Hospital
Division name
Gastrointestinal Oncology Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
aoitonoria@yahoo.co.jp
Sponsor or person
Institute
National Cancer Center Hospital, Gastrointestinal Oncology Division
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital, Gastrointestinal Oncology Division
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2007 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 03 | Month | 01 | Day |
Last modified on
| 2010 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001283
