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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00065468




Registration number
NCT00065468
Ethics application status
Date submitted
24/07/2003
Date registered
25/07/2003
Date last updated
25/10/2012

Titles & IDs
Public title
Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma
Scientific title
A Phase 3, Three-Arm, Randomized, Open-Label Study Of Interferon Alfa Alone, CCI-779 Alone, And The Combination Of Interferon Alfa And CCI-779 In First-Line Poor-Prognosis Subjects With Advanced Renal Cell Carcinoma.
Secondary ID [1] 0 0
3066K1-304
Universal Trial Number (UTN)
Trial acronym
ARCC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Renal Cell 0 0
Kidney Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Interferon Alfa
Treatment: Drugs - CCI-779
Treatment: Drugs - Interferon Alfa and CCI-779

Active Comparator: A -

Experimental: B -

Experimental: C -


Treatment: Drugs: Interferon Alfa
Interferon alfa (Roferon) 3 MU given Sub Cutaneously three time /week for the first week, 9 MU given Sub Cutaneously three time /week for the second week, 18 MU given Sub Cutaneously three time /week thereafter.

Treatment: Drugs: CCI-779
25 mg of CCI-779 given Intra Venously once per week

Treatment: Drugs: Interferon Alfa and CCI-779
15 mg of CCI-779 given Intra Venously once per week; 6 MU of IFN alfa (Roferon) given Sub Cutaneously three time /week

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.
Timepoint [1] 0 0
Baseline up to Month 80
Secondary outcome [1] 0 0
Progression-Free Survival (PFS) - PFS based on Independent Central Review Assessment. The period from randomization until disease progression, death or date of last contact.
Timepoint [1] 0 0
Baseline, monthly until tumor progression or death (up to Month 80)
Secondary outcome [2] 0 0
Percentage of Participants With Objective Response - Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was the disappearance of all target lesions and non target lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Timepoint [2] 0 0
Baseline, every 2 months until tumor progression or death (up to Month 80)
Secondary outcome [3] 0 0
Percentage of Participants With Clinical Benefit - Clinical benefit: confirmed CR or PR or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and non target lesions. PR was at least a 30% decrease in sum of the LD of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Timepoint [3] 0 0
Baseline, every 2 months until tumor progression or death (up to Month 80)
Secondary outcome [4] 0 0
Duration of Response (DR) - DR: Time from first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented, taking as a reference for PD, the smallest sum LD recorded since randomization.
Timepoint [4] 0 0
Baseline, every month until tumor progression or death (up to Month 80)
Secondary outcome [5] 0 0
Time to Treatment Failure (TTF) - TTF is defined as the time from the date of randomization to the date of PD or death, withdrawal from treatment due to an adverse event (AE), withdrawal of voluntary consent, or lost to follow-up, whichever occurred first, censored at the date of the conclusion of treatment phase.
Timepoint [5] 0 0
Baseline, every month until tumor progression or death (up to Month 80)
Secondary outcome [6] 0 0
Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) - The Q-Twist is not a score calculated for each participant but is defined only on a by treatment group basis. For each treatment group, it is the weighted sum of the mean durations of the health states Tox, Twist, and Relapse. Tox is defined as time with severe toxicity related to treatment; Twist: time without symptoms or toxic side effects; and Relapse: time after relapse/progression. The mean duration of each health state is calculated based on the area under the Kaplan Meier curve pertaining to that health state. There is no direct method for calculating the "dispersion" of Q-Twist, and it is typically done using bootstrap method for purposes of inference (see, e.g., Glasziou PP, Simes RJ, Gelber RD. Quality adjusted survival analysis. Stat Med 1990; 9: 1259-76). In practice, as apparently in the case with this study, the intermediate values resulting from the bootstrap exercise were not displayed.
Timepoint [6] 0 0
Baseline to Month 80
Secondary outcome [7] 0 0
European Quality of Life Health Questionnaire (EQ-5D) - Index Score - EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. EQ-5D index measured 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Range of EQ-5D index score = -0.594 to 1 where higher scores indicated a better health state.
Timepoint [7] 0 0
Baseline

Eligibility
Key inclusion criteria
- This study will be conducted in subjects with histologically confirmed, advanced
(stage IV or recurrent disease) RCC who have not received prior systemic therapy for
their disease,
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects with central nervous system (CNS) metastases

- Prior anticancer therapy for RCC

- Prior investigational therapy/agents within 4 weeks of randomization

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Kogarah
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Newcastle
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Westmead
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Footscray
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Heidelberg
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
- Newcastle
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3012 - Footscray
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3050 - Melbourne
Recruitment outside Australia
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Surrey
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Nottingham
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is efficacy. The primary efficacy endpoint of this study
is a comparison of the overall survival of subjects treated with CCI-779 [Temsirolimus],
administered intravenously [IV] once weekly and the combination of CCI-779, administered IV
once weekly with Interferon Alfa [IFN alfa] subcutaneously [SC] three times per week [TIW],
compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in
poor-prognosis subjects with advanced RCC.
Trial website
https://clinicaltrials.gov/show/NCT00065468
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications