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

Sponsor:	Pfizer
Information provided by:	Pfizer
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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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: Sirolimus Interferon alfa-2a Everolimus CCI 779 Interferon alfa-n1 Interferons

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Comparison of the overall survival of subjects treated with CCI-779 alone, and the combination of CCI-779 + IFN alfa, compared with the overall survival of subjects treated with IFN alfa alone [ Time Frame: Weekly during treatment phase, then every 2 months during follow-up period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety: Frequency and severity of adverse events [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
Use of health outcome questionnaire EuroQo1 EQ-5D to explore quality of life. [ Time Frame: Screening, week 12, week 32 ] [ Designated as safety issue: Yes ]
Progression Free Survival, response rate (complete response and partial response ), clinical benefit rate (Complete Response/Partial Response /Stable Disease >= 24 weeks) duration of overall response, time to treatment failure [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	626
Study Start Date:	July 2003
Study Completion Date:	March 2011
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A	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.
Experimental: B	Drug: CCI-779 25 mg of CCI-779 given Intra Venously once per week
Experimental: C	Drug: 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

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

Show 154 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT00065468 History of Changes
Obsolete Identifiers:	NCT00070330
Other Study ID Numbers:	3066K1-304
Study First Received:	July 24, 2003
Last Updated:	June 3, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Advanced Renal Cell Carcinoma
Kidney Cancer

Additional relevant MeSH terms:

Neoplasms
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Interferon-alpha
Interferon Alfa-2a
Interferons

Sirolimus
Everolimus
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antibiotics, Antineoplastic
Antifungal Agents

ClinicalTrials.gov processed this record on February 12, 2012