Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma

Carcinoma, Renal Cell Clinical Trial

— ARCC  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00065468
• Other study ID #: 3066K1-304
• Status: Completed
• Phase: Phase 3
• First received: July 24, 2003
• Last updated: September 24, 2012
• Start date: July 2003
• Est. completion date: March 2011

Study information

• Verified date: September 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00070330

Recruitment information / eligibility

• Status: Completed
• Enrollment: 626
• Est. completion date: March 2011
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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,

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Kidney Neoplasms

Intervention

Drug:
• 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.
• CCI-779
25 mg of CCI-779 given Intra Venously once per week
• 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

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Buenos	Aires
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Cordoba
Argentina	Pfizer Investigational Site	Mendoza
Argentina	Pfizer Investigational Site	Quilmes
Argentina	Pfizer Investigational Site	San Miguel de Tucuman	Tucuman
Argentina	Pfizer Investigational Site	Unknown
Australia	Pfizer Investigational Site	Adelaide	South Australia
Australia	Pfizer Investigational Site	Footscray	Victoria
Australia	Pfizer Investigational Site	Heidelberg	Victoria
Australia	Pfizer Investigational Site	Kogarah	New South Wales
Australia	Pfizer Investigational Site	Melbourne	Victoria
Australia	Pfizer Investigational Site	Newcastle	New South Wales
Australia	Pfizer Investigational Site	Westmead	New South Wales
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Greenfield Park	Quebec
Canada	Pfizer Investigational Site	Halifax	Nova Scotia
Canada	Pfizer Investigational Site	Hamilton, Ontario
Canada	Pfizer Investigational Site	Kelowna	British Columbia
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Newmarket	Ontario
Canada	Pfizer Investigational Site	Ottawa	Ontario
Canada	Pfizer Investigational Site	Quebec City	Quebec
Canada	Pfizer Investigational Site	Sherbrooke	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Czech Republic	Pfizer Investigational Site	Brno
Czech Republic	Pfizer Investigational Site	Prague 5
Former Serbia and Montenegro	Pfizer Investigational Site	Sremska Kamenica	Novi Sad
Germany	Pfizer Investigational Site	Bonn	NRW
Germany	Pfizer Investigational Site	Essen	NRW
Germany	Pfizer Investigational Site	Mainz	RP
Greece	Pfizer Investigational Site	Heraklion	Creete
Greece	Pfizer Investigational Site	Patra
Hungary	Pfizer Investigational Site	Budapest
Italy	Pfizer Investigational Site	Foggia
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Roma	RM
Latvia	Pfizer Investigational Site	Daugavpils
Latvia	Pfizer Investigational Site	Riga
Latvia	Pfizer Investigational Site	Riga
Lithuania	Pfizer Investigational Site	Vilnius
Mexico	Pfizer Investigational Site	Leon Guanajuato
Mexico	Pfizer Investigational Site	Monterrey	Nuevo Leon
Netherlands	Pfizer Investigational Site	Amsterdam
Netherlands	Pfizer Investigational Site	Enschede
Netherlands	Pfizer Investigational Site	Nijmegen	GA
Poland	Pfizer Investigational Site	Bytom
Poland	Pfizer Investigational Site	Lodz
Poland	Pfizer Investigational Site	Lublin
Poland	Pfizer Investigational Site	Olsztyn
Poland	Pfizer Investigational Site	Opole
Poland	Pfizer Investigational Site	Poznan
Poland	Pfizer Investigational Site	Siedlce
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Russian Federation	Pfizer Investigational Site	Barnaul
Russian Federation	Pfizer Investigational Site	Kemerovo
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Obninsk
Russian Federation	Pfizer Investigational Site	Saint Petersburg
Russian Federation	Pfizer Investigational Site	Saint Petersburg
Russian Federation	Pfizer Investigational Site	Saint Petersburg
Russian Federation	Pfizer Investigational Site	Saint Petersburg
Russian Federation	Pfizer Investigational Site	St Petersburg
Russian Federation	Pfizer Investigational Site	Ufa
Russian Federation	Pfizer Investigational Site	Ufa
Serbia	Pfizer Investigational Site	Belgrade
Slovakia	Pfizer Investigational Site	Banska Bystrica
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Martin
Slovakia	Pfizer Investigational Site	Zlina
South Africa	Pfizer Investigational Site	Cape Town
South Africa	Pfizer Investigational Site	Gauteng
South Africa	Pfizer Investigational Site	Johannesburg	Gauteng
South Africa	Pfizer Investigational Site	Port Elizabeth	Eastern Cape
Spain	Pfizer Investigational Site	Badalona	Barcelona
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Oviedo	Asturias
Sweden	Pfizer Investigational Site	Göteborg
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Uppsala
Taiwan	Pfizer Investigational Site	Taichung
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei	ROC
Taiwan	Pfizer Investigational Site	Taoyuan
Turkey	Pfizer Investigational Site	Istanbul
Turkey	Pfizer Investigational Site	Izmir
Ukraine	Pfizer Investigational Site	Dnietropetrovsk
Ukraine	Pfizer Investigational Site	Donetsk
Ukraine	Pfizer Investigational Site	Kharkov
Ukraine	Pfizer Investigational Site	Kiev
Ukraine	Pfizer Investigational Site	Lviv
Ukraine	Pfizer Investigational Site	Zaporozhye
United Kingdom	Pfizer Investigational Site	Glasgow	Strathclyde
United Kingdom	Pfizer Investigational Site	Manchester	Lancashire
United Kingdom	Pfizer Investigational Site	Nottingham
United Kingdom	Pfizer Investigational Site	Sutton	Surrey
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Billings	Montana
United States	Pfizer Investigational Site	Boca Raton	Florida
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Bronx	New York
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	East Orange	New Jersey
United States	Pfizer Investigational Site	Great Falls	Montana
United States	Pfizer Investigational Site	Hershey	Pennsylvania
United States	Pfizer Investigational Site	Hickory	North Carolina
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Kansas City	Kansas
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Knoxville	Tennessee
United States	Pfizer Investigational Site	La Verne	California
United States	Pfizer Investigational Site	Lebanon	New Hampshire
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Morristown	New Jersey
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	New Orleans	Louisiana
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	South Bend	Indiana
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	Terre Haute	Indiana
United States	Pfizer Investigational Site	Urbana	Illinois
United States	Pfizer Investigational Site	Valhalla	New York
United States	Pfizer Investigational Site	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Czech Republic,  Former Serbia and Montenegro,  Germany,  Greece,  Hungary,  Italy,  Latvia,  Lithuania,  Mexico,  Netherlands,  Poland,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline up to Month 80	No
Secondary	Progression-Free Survival (PFS)	PFS based on Independent Central Review Assessment. The period from randomization until disease progression, death or date of last contact.	Baseline, monthly until tumor progression or death (up to Month 80)	No
Secondary	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.	Baseline, every 2 months until tumor progression or death (up to Month 80)	No
Secondary	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.	Baseline, every 2 months until tumor progression or death (up to Month 80)	No
Secondary	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.	Baseline, every month until tumor progression or death (up to Month 80)	No
Secondary	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.	Baseline, every month until tumor progression or death (up to Month 80)	No
Secondary	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.	Baseline to Month 80	Yes
Secondary	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.	Baseline	No

External Links

•   To obtain contact information for a study center near you, click here.