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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00631371
First received: February 28, 2008
Last updated: March 25, 2014
Last verified: March 2014
  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:


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: June 2014
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631371

  Show 150 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00631371     History of Changes
Other Study ID Numbers: 3066K1-3311, B1771006
Study First Received: February 28, 2008
Results First Received: April 18, 2013
Last Updated: March 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
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
Interferon-alpha
Interferon Alfa-2a
Interferons
Sirolimus
Everolimus
Bevacizumab
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

ClinicalTrials.gov processed this record on April 15, 2014