Expired Study
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New Haven, Connecticut 06520


Purpose:

The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).


Criteria:

Inclusion Criteria: - Histologically confirmed renal cell carcinoma of clear cell histology with metastases - Evidence of measurable disease by radiographic technique - Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1 Exclusion Criteria: - Prior systemic (including adjuvant or neoadjuvant) therapy of any kind for RCC - History of or known brain metastases - Serious acute or chronic illness or recent history of significant cardiac abnormality


Study is Available At:


Original ID:

A6181034


NCT ID:

NCT00083889


Secondary ID:


Study Acronym:


Brief Title:

SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma


Official Title:

A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

750


Enrollment Type:

Actual


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:August 2004
Completion Date:September 2008
Completion Type:Actual
Primary Completion Date:September 2008
Primary Completion Type:Actual
Verification Date:January 2010
Last Changed Date:January 19, 2010
First Received Date:June 3, 2004
First Results Date:September 16, 2009

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Ctrough Concentrations of SU011248 and Active Metabolite SU012662
Time Frame:Day 28 of Cycle 1 to Cycle 4
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Ctrough Concentrations of Metabolite SU012662
Time Frame:Day 28 of Cycle 1 to Cycle 4
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Ctrough Concentrations of SU011248
Time Frame:Day 28 of Cycle 1 to Cycle 4
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incremental Cost Effectiveness Ratio (ICER)
Time Frame:post study measurement
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis
Time Frame:Day 1 & Day 28, Cycle 1 to Cycle 4
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis
Time Frame:Day 1 & Day 28, Cycle 1 to Cycle 4
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Euro-QoL Visual Analog Scale (EQ-VAS)
Time Frame:Day 1 & 28 of each cycle: duration of treatment phase
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:EuroQoL Five Dimension (EQ-5D) Health State Index
Time Frame:Day 1 & 28 of each cycle: duration of treatment phase
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale
Time Frame:Day 1 & 28 of each cycle: duration of treatment phase
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale
Time Frame:Day 1 & 28 of each cycle: duration of treatment phase
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale
Time Frame:Day 1 & 28 of each cycle: duration of treatment phase
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale
Time Frame:Day 1 & 28 of each cycle: duration of treatment phase
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Functional Assessment of Cancer Therapy-General (FACT-G)
Time Frame:Day 1 & 28 of each cycle: duration of treatment phase
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:FACT-Kidney Symptom Index (FKSI) Subscale
Time Frame:Day 1 & 28 of each cycle: duration of treatment phase
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale
Time Frame:Day 1 & 28 of each cycle: duration of treatment phase
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Duration of Response (DR), Investigator's Assessment
Time Frame:Day 28 of each cycle: duration of treatment phase
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Duration of Response (DR), Core Radiology Assessement
Time Frame:Day 28 of each cycle: duraton of treatment phase
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to Tumor Progression (TTP), Investigator's Assessment
Time Frame:Randomization to first documentation of tumor progression: duration of treatment phase
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to Tumor Progression (TTP), Core Radiology Assessment
Time Frame:Randomization to first documentation of tumor progression: duration of treatment phase
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Overall Survival (OS)
Time Frame:Clinic visit or telephone contact every 2 months until death
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Objective Response, Investigator's Assessment
Time Frame:Day 28 of each 6-week cycle: duration of treatment phase
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Objective Response, Core Radiology Assessment
Time Frame:Day 28 of each 6-week cycle: duration of treatment phase
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Progression-Free Survival (PFS), Investigator's Assessment
Time Frame:Day 28 of each 6-week cycle: duration of treatment phase
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Progression-Free Survival (PFS), Core Radiology Assessment
Time Frame:Day 28 of each 6-week cycle: duration of treatment phase
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Interferon-alfa
Description:3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity
Arm Name:2
Other Name:Roferon
Intervention Type:Drug
Name:SU011248
Description:50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity
Arm Name:1
Other Name:Sunitinib, SUTENT

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Study Arm Type:Experimental
Arm Name:1

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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