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

Phase 3

Completed

Conditions: Carcinoma, Renal Cell
Kidney Neoplasms

Interventions: Drug: CCI-779
Drug: Interferon Alfa and CCI-779
Drug: Interferon Alfa

Registration Number: NCT00065468

Lead Sponsor: Pfizer

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 626

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	CCI-779	-
C	Interferon Alfa and CCI-779	-
A	Interferon Alfa	-

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Baseline up to Month 80	Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Baseline, monthly until tumor progression or death (up to Month 80)	PFS based on Independent Central Review Assessment. The period from randomization until disease progression, death or date of last contact.
Percentage of Participants With Objective Response	Baseline, every 2 months until tumor progression or death (up to Month 80)	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.
Percentage of Participants With Clinical Benefit	Baseline, every 2 months until tumor progression or death (up to Month 80)	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.
Duration of Response (DR)	Baseline, every month until tumor progression or death (up to Month 80)	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.
Time to Treatment Failure (TTF)	Baseline, every month until tumor progression or death (up to Month 80)	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.
Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST)	Baseline to Month 80	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.
European Quality of Life Health Questionnaire (EQ-5D) - Index Score	Baseline	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.