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

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ClinicalTrials.gov Identifier: NCT00631371
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : June 4, 2013
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

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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, Older Adult)
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631371


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00631371    
Other Study ID Numbers: 3066K1-3311
B1771006 ( Other Identifier: Alias Study Number )
2007-003793-26 ( EudraCT Number )
First Posted: March 7, 2008    Key Record Dates
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:
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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
Interferons
Interferon-alpha
Sirolimus
 Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents