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

Arm | Intervention/treatment |
---|---|
Experimental: 1
Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly
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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 |
- 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.
- 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.
- 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.
- 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).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
temsirolimus renal cell carcinoma kidney cancer urogenital cancer |
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 |