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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Renal Cell; Kidney Neoplasms

Treatments: Drug: Interferon Alfa and CCI-779; Drug: CCI-779; Drug: Interferon Alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00065468

3066K1-304

Details and patient eligibility

About

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.

Enrollment: 626 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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626 participants in 3 patient groups

A

Active Comparator group

Treatment:

Drug: Interferon Alfa

B

Experimental group

Treatment:

Drug: CCI-779

C

Experimental group

Treatment:

Drug: Interferon Alfa and CCI-779