Study Evaluating Interferon and CCI-779 in Advanced Renal Cell Carcinoma - Full Text View

Purpose

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, administered IV once weekly and the combination of CCI-779, administered IV once weekly with IFN alfa (SC TIW), compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced RCC.

Condition	Intervention	Phase
Carcinoma, Renal Cell Kidney Neoplasms	Drug: Interferon Alfa Drug: CCI-779 Drug: Interferon Alfa and CCI-779	Phase III

MedlinePlus related topics:

Cancer Kidney Cancer

Drug Information available for:

Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons CCI 779

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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.

Further study details as provided by Wyeth:

Primary Outcome Measures:

Overall survival [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]

Estimated Enrollment:	626
Study Start Date:	March 2001
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: Interferon Alfa Interferon alfa (Roferon) 3 MU SC TIW for the first week, 9 MU SC TIW for the second week, 18 MU SC TIW thereafter.
B: Experimental	Drug: CCI-779 25 mg of CCI-779 IV once per week
C: Experimental	Drug: Interferon Alfa and CCI-779 15 mg of CCI-779 IV once per week; 6 MU of IFN alfa (Roferon) SC TIW

Detailed Description:

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, administered IV once weekly and the combination of CCI-779, administered IV once weekly with IFN alfa (SC TIW), compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced Renal Cell Carcinoma (RCC).

The secondary objectives of this study are safety, health outcomes, and additional efficacy endpoints. The secondary efficacy endpoints of this study are an evaluation of the following endpoints in subjects treated with CCI-779, administered IV once weekly and the combination of CCI-779, administered IV once weekly with IFN alfa (SC TIW), compared with subjects treated with IFN alfa (SC TIW) alone: progression-free survival (PFS), response rate (complete response [CR] and partial response [PR]), clinical benefit rate (CR/PR/stable disease [SD]), the duration of overall response, time to treatment failure (TTF), and health outcomes measurements. In addition, subject responses across all 3 treatment arms will be evaluated based on screening tumor expression of proteins involved in AKT-mTor pathway (i.e., Akt phosphorylation, PTEN expression).

This study will evaluate the safety of subjects treated with CCI-779 and CCI-779 given in combination with IFN alfa compared with subjects treated with IFN alfa alone.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065468

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor, MD	Wyeth

More Information

Publications indexed to this study:

Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, Staroslawska E, Sosman J, McDermott D, Bodrogi I, Kovacevic Z, Lesovoy V, Schmidt-Wolf IG, Barbarash O, Gokmen E, O'Toole T, Lustgarten S, Moore L, Motzer RJ; Global ARCC Trial. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007 May 31;356(22):2271-81.

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3066K1-304
First Received:	July 24, 2003
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00065468
Health Authority:	United States: Food and Drug Administration; European Union: European Medicines Agency; Australia: Department of Health and Ageing Therapeutic Goods Administration; Canada: Health Canada

Keywords provided by Wyeth:

Advanced Renal Cell Carcinoma

Kidney Cancer

Study placed in the following topic categories:

Interferon-alpha

Interferon Type I, Recombinant

Interferons

Urogenital Neoplasms

Renal cancer

Urologic Neoplasms

Kidney cancer

Carcinoma

Urologic Diseases

Kidney Neoplasms

Carcinoma, Renal Cell

Kidney Diseases

Adenocarcinoma

Interferon Alfa-2a

Interferon Alfa-2b

Urinary tract neoplasm

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Infective Agents

Neoplasms by Histologic Type

Immunologic Factors

Antineoplastic Agents

Growth Substances

Physiological Effects of Drugs

Antiviral Agents

Angiogenesis Inhibitors

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Therapeutic Uses

Angiogenesis Modulating Agents

Growth Inhibitors

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00065468