Trial · NCT00378703

Bevacizumab, Sorafenib Tosylate, and Temsirolimus in Treating Patients With Metastatic Kidney Cancer

NCT00378703, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-05-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Bevacizumab, Sorafenib Tosylate, and Temsirolimus in Treating Patients With Metastatic Kidney Cancer. Trials, record NCT00378703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00378703

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Bevacizumab, Sorafenib Tosylate, and Temsirolimus in Treating Patients With Metastatic Kidney Cancer
NCT number: NCT00378703
Status: Completed
Phases: Phase 2
Enrollment: 361 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Clear Cell Renal Cell Carcinoma, Recurrent Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v7
Interventions: Bevacizumab, Laboratory Biomarker Analysis, Pharmacological Study, Sorafenib Tosylate, Temsirolimus
First posted: 2006-09-21
Last updated: 2018-11-14
Results first posted: 2015-05-05

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-free Survival (PFS)	Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years	Progression-free survival is defined as time from randomization to clinical evidence of disease progression or death from any cause without progression. Patients alive without progression were censored at the date of last disease assessment.
Secondary	Proportion of Patients With Stable Disease at 6 Months	Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years	Patients whose date of progression was after 6 months or who were disease-free at last follow-up beyond 6 months were considered to be stable at 6 months and all other patients were not.
Secondary	Overall Survival	Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years	Overall survival was defined as the time from randomization to death. Patients alive at last contact were censored on the date of last contact.
Secondary	Objective Response Rate	Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years	Response was assessed using Solid Tumor Response Criteria (RECIST). Patients with complete responses or partial responses are considered having an objective response.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival (PFS)	Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years	Eligible, treated patients	Months	MEDIAN
SECONDARY	Proportion of Patients With Stable Disease at 6 Months	Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years	Eligible, treated patients	Proportion of patients	NUMBER
SECONDARY	Overall Survival	Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years	Eligible, treated patients	Months	MEDIAN
SECONDARY	Objective Response Rate	Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years	Eligible, treated patients	Proportion of patients	NUMBER

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression-free Survival (PFS)	Arm A (Bevacizumab)	7.5	90% Confidence Interval 5.8 to 10.8	Months
Progression-free Survival (PFS)	Arm B (Bevacizumab and Temsirolimus)	7.6	90% Confidence Interval 6.7 to 9.2	Months
Progression-free Survival (PFS)	Arm C (Bevacizumab and Sorafenib)	9.2	90% Confidence Interval 7.5 to 11.4	Months
Progression-free Survival (PFS)	Arm D (Sorafenib and Temsirolimus)	7.4	90% Confidence Interval 5.6 to 7.9	Months
Proportion of Patients With Stable Disease at 6 Months	Arm A (Bevacizumab)	0.548	95% Confidence Interval 0.435 to 0.657	Proportion of patients
Proportion of Patients With Stable Disease at 6 Months	Arm B (Bevacizumab and Temsirolimus)	0.562	95% Confidence Interval 0.447 to 0.673	Proportion of patients
Proportion of Patients With Stable Disease at 6 Months	Arm C (Bevacizumab and Sorafenib)	0.590	95% Confidence Interval 0.477 to 0.697	Proportion of patients
Proportion of Patients With Stable Disease at 6 Months	Arm D (Sorafenib and Temsirolimus)	0.524	95% Confidence Interval 0.412 to 0.634	Proportion of patients
Overall Survival	Arm A (Bevacizumab)	28.6	90% Confidence Interval 22.3 to 34.9	Months
Overall Survival	Arm B (Bevacizumab and Temsirolimus)	24.7	90% Confidence Interval 21.4 to 35.3	Months

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow20

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A (Bevacizumab)	89
Overall Study	STARTED	Arm B (Bevacizumab and Temsirolimus)	91
Overall Study	STARTED	Arm C (Bevacizumab and Sorafenib)	90
Overall Study	STARTED	Arm D (Sorafenib and Temsirolimus)	91
Overall Study	Treated	Arm A (Bevacizumab)	88
Overall Study	Treated	Arm B (Bevacizumab and Temsirolimus)	86
Overall Study	Treated	Arm C (Bevacizumab and Sorafenib)	90
Overall Study	Treated	Arm D (Sorafenib and Temsirolimus)	91
Overall Study	Eligible and Treated	Arm A (Bevacizumab)	84
Overall Study	Eligible and Treated	Arm B (Bevacizumab and Temsirolimus)	80

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events784

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Allergic reaction	Immune system disorders	Arm A (Bevacizumab)	0	88
other	Allergic reaction	Immune system disorders	Arm B (Bevacizumab and Temsirolimus)	5	86
other	Allergic reaction	Immune system disorders	Arm C (Bevacizumab and Sorafenib)	0	90
other	Allergic reaction	Immune system disorders	Arm D (Sorafenib and Temsirolimus)	4	91
other	Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	Arm A (Bevacizumab)	9	88
other	Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	Arm B (Bevacizumab and Temsirolimus)	10	86
other	Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	Arm C (Bevacizumab and Sorafenib)	9	90
other	Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	Arm D (Sorafenib and Temsirolimus)	5	91
other	Hemoglobin	Blood and lymphatic system disorders	Arm A (Bevacizumab)	30	88
other	Hemoglobin	Blood and lymphatic system disorders	Arm B (Bevacizumab and Temsirolimus)	65	86

1 to 10 of 784Source ClinicalTrials.gov

See all 784 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A (Bevacizumab)
Total, all-cause mortality	Arm B (Bevacizumab and Temsirolimus)
Total, all-cause mortality	Arm C (Bevacizumab and Sorafenib)
Total, all-cause mortality	Arm D (Sorafenib and Temsirolimus)
Total, other adverse events	Arm A (Bevacizumab)	80	88
Total, other adverse events	Arm B (Bevacizumab and Temsirolimus)	86	86
Total, other adverse events	Arm C (Bevacizumab and Sorafenib)	89	90
Total, other adverse events	Arm D (Sorafenib and Temsirolimus)	90	91
Total, serious adverse events	Arm A (Bevacizumab)	39	88
Total, serious adverse events	Arm B (Bevacizumab and Temsirolimus)	66	86

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26077237	DERIVED

Source PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U10CA180820	ECOG-ACRIN Network Group Operations Center	ODwyer, Peter J; SCHNALL, MITCHELL D.	ECOG-ACRIN MEDICAL RESEARCH FOUNDATION	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA021115	Eastern Cooperative Oncology Group Operations Office	COMIS, ROBERT L	FRONTIER SCI & TECHNOLOGY RSCH FDN, INC	NATIONAL CANCER INSTITUTE	1985 to 2013	NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00378703

GET https://conductscience.org/api/trials/v1/NCT00378703/events?page=2

API reference For AI assistants