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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00631371
Registration number
NCT00631371
Ethics application status
Date submitted
28/02/2008
Date registered
7/03/2008
Date last updated
27/04/2016
Titles & IDs
Public title
Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects
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Scientific title
Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus Vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma
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Secondary ID [1]
0
0
B1771006
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Secondary ID [2]
0
0
3066K1-3311
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Universal Trial Number (UTN)
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Trial acronym
INTORACT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma
0
0
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Condition category
Condition code
Cancer
0
0
0
0
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Non melanoma skin cancer
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Cancer
0
0
0
0
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Temsirolimus
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Interferon-Alfa 9MU
Experimental: 1 - Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly
Active Comparator: 2 - Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW
Treatment: Drugs: Bevacizumab
Bevacizumab 10 mg/kg intravenous (IV) q8wks
Treatment: Drugs: Temsirolimus
Temsirolimus 25 mg IV weekly
Treatment: Drugs: Bevacizumab
Bevacizumab 10 mg/kg intravenous (IV) q8wks
Treatment: Drugs: Interferon-Alfa 9MU
Interferon-Alfa 9MU SC TIW
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS): Independent-Assessment
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Assessment method [1]
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PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.
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Timepoint [1]
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0
Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
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Secondary outcome [1]
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Progression-Free Survival (PFS): Investigator-Assessment
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Assessment method [1]
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PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by investigator imaging reviewers using RECIST criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.
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Timepoint [1]
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Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
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Secondary outcome [2]
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Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment
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Assessment method [2]
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Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
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Timepoint [2]
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Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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OS was defined as the time from randomization to death due to any cause, censored at the last date known alive. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
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Timepoint [3]
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Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012)
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Eligibility
Key inclusion criteria
- Histologically and/or cytologically confirmed to have advanced renal cell carcinoma
(RCC)
- Majority component of conventional clear-cell type is mandatory
- At least 1 measurable lesion (per RECIST)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prior systemic treatment for RCC
- Evidence of current or prior central nervous system (CNS) metastases
- Cardiovascular disease
- Pregnant or nursing women
- Additional criteria applies
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2015
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Sample size
Target
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Accrual to date
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Final
791
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Recruitment in Australia
Recruitment state(s)
QLD,SA
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Recruitment hospital [1]
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Mater Adult Hospital - South Brisbane
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Royal Adelaide Hospital - Adelaide
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Ashford Cancer Center Research - Kurralta Park
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Cancer Care SA - Kurralta Park
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Mater Private Hospital - South Brisbane
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Recruitment postcode(s) [1]
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4101 - South Brisbane
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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5037 - Kurralta Park
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Recruitment postcode(s) [4]
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QLD 4101 - South Brisbane
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Ethics approval
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Summary
Brief summary
Primary objective: Comparison of independently assessed progression free survival (PFS) in
subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab +
Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response
rate (independently assessed), and overall survival.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00631371
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00631371
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