Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects - Full Text View

Purpose

Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.

Condition	Intervention	Phase
Renal Cell Carcinoma	Drug: Bevacizumab Drug: Temsirolimus Drug: Interferon-Alfa 9MU	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 3b, Randomized, Open-label Study Of Bevacizumab + Temsirolimus Vs. Bevacizumab + Interferon-alfa As First-line Treatment In Subjects With Advanced Renal Cell Carcinoma

Resource links provided by NLM:

Drug Information available for: Interferon Sirolimus Interferon Alfa-2a Everolimus Temsirolimus Bevacizumab

Genetic and Rare Diseases Information Center resources: Kidney Cancer Renal Cancer

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Progression-Free Survival (PFS): Independent-Assessment [ Time Frame: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012) ] [ Designated as safety issue: No ]
PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.

Secondary Outcome Measures:

Progression-Free Survival (PFS): Investigator-Assessment [ Time Frame: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012) ] [ Designated as safety issue: No ]
PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by investigator imaging reviewers using RECIST criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.
Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment [ Time Frame: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012) ] [ Designated as safety issue: No ]
Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
Overall Survival (OS) [ Time Frame: Baseline until death due to any caused, assessed every 8 weeks (up to cut-off date: 19 April 2012) ] [ Designated as safety issue: No ]
OS was defined as the time from randomization to death due to any cause, censored at the last date known alive. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).


Enrollment:	791
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2015
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly	Drug: Bevacizumab Bevacizumab 10 mg/kg intravenous (IV) q8wks Other Name: Torisel Drug: Temsirolimus Temsirolimus 25 mg IV weekly
Active Comparator: 2 Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW	Drug: Bevacizumab Bevacizumab 10 mg/kg intravenous (IV) q8wks Drug: Interferon-Alfa 9MU Interferon-Alfa 9MU SC TIW

Eligibility


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

Criteria

Inclusion Criteria:

Histologically and/or cytologically confirmed to have advanced renal cell carcinoma (RCC)
Majority component of conventional clear-cell type is mandatory
At least 1 measurable lesion (per RECIST)

Exclusion Criteria:

Prior systemic treatment for RCC
Evidence of current or prior central nervous system (CNS) metastases
Cardiovascular disease
Pregnant or nursing women
Additional criteria applies

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631371

Show 172 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):

Rini BI, Bellmunt J, Clancy J, Wang K, Niethammer AG, Hariharan S, Escudier B. Randomized phase III trial of temsirolimus and bevacizumab versus interferon alfa and bevacizumab in metastatic renal cell carcinoma: INTORACT trial. J Clin Oncol. 2014 Mar 10;32(8):752-9. doi: 10.1200/JCO.2013.50.5305. Epub 2013 Dec 2.


Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00631371 History of Changes
Other Study ID Numbers:	3066K1-3311, B1771006, 2007-003793-26
Study First Received:	February 28, 2008
Results First Received:	April 18, 2013
Last Updated:	November 25, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:


temsirolimus renal cell carcinoma kidney cancer urogenital cancer

Additional relevant MeSH terms:


Carcinoma, Renal Cell Adenocarcinoma Carcinoma Kidney Diseases Kidney Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Bevacizumab Everolimus Interferon-alpha	Interferons Sirolimus Angiogenesis Inhibitors Angiogenesis Modulating Agents Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents Antineoplastic Agents Antiviral Agents Growth Inhibitors Growth Substances Immunologic Factors Immunosuppressive Agents Pharmacologic Actions

ClinicalTrials.gov processed this record on March 03, 2015

Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects (INTORACT)