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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Renal Cell Carcinoma	Drug: Bevacizumab; Drug: Temsirolimus; Drug: Interferon-Alfa 9MU	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	791 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	April 2008
Actual Primary Completion Date :	April 2012
Actual Study Completion Date :	April 2015

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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) ]
   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 :

1. 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) ]
   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.
2. 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) ]
   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.
3. Overall Survival (OS) [ Time Frame: Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012) ]
   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).

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Additional Information:

To obtain contact information for a study center near you, click here. 

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

Grünwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.

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 ( Other Identifier: Alias Study Number ); 2007-003793-26 ( EudraCT Number )
First Posted:	March 7, 2008
Results First Posted:	June 4, 2013
Last Update Posted:	April 27, 2016
Last Verified:	March 2016

Keywords provided by Pfizer:

temsirolimus; renal cell carcinoma; kidney cancer; urogenital cancer

Additional relevant MeSH terms:

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