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

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

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

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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Interferon alfa-2a CCI 779 Interferon alfa-n1 Interferons

U.S. FDA Resources

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

No publications provided by Wyeth

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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
Study First Received:	July 24, 2003
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00065468 History of Changes
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

Additional relevant MeSH terms:

Anti-Infective Agents
Interferon Type I, Recombinant
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Growth Inhibitors
Kidney Diseases
Angiogenesis Modulating Agents

Interferon-alpha
Neoplasms by Histologic Type
Growth Substances
Interferons
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Carcinoma, Renal Cell
Adenocarcinoma
Interferon Alfa-2a
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2009