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Vorinostat and Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer

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ClinicalTrials.gov Identifier: NCT00324870
Recruitment Status : Completed
First Posted : May 11, 2006
Results First Posted : September 9, 2015
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Cancer
Stage III Renal Cell Cancer
Stage IV Renal Cell Cancer
Interventions Drug: vorinostat
Drug: bevacizumab
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I
Hide Arm/Group Description

Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.

Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.

vorinostat: Given orally

bevacizumab: Given IV

Period Title: Overall Study
Started 37
Completed 37
Not Completed 0
Arm/Group Title Arm I
Hide Arm/Group Description

Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.

Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.

vorinostat: Given orally

bevacizumab: Given IV

Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 37 participants
64
(34 to 82)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
  54.1%
>=65 years
17
  45.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
6
  16.2%
Male
31
  83.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants
37
1.Primary Outcome
Title Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) (Phase II)
Hide Description Estimated by Kaplan-Meier method
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Progression free survival was summarized for the entire sample (n=37). The median survival times and 6-month survival rates are estim. based on the KP curve,w/ corresp. 95% confidence intervals using the log-log method. Conducted in SAS v9.3(Cary, NC). Progr.free survival time is calc. from date of first tx until date of progres./death or last fu.
Arm/Group Title Arm I
Hide Arm/Group Description:

Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.

Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.

vorinostat: Given orally

bevacizumab: Given IV

Overall Number of Participants Analyzed 37
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent
48.6
(32 to 63.4)
2.Other Pre-specified Outcome
Title Maximum Tolerated Dose
Hide Description Determine the maximum tolerated dose of SAHA
Time Frame 18 months from first patient dosing
Outcome Measure Data Not Reported
3.Other Pre-specified Outcome
Title Clinical Response Rate of SAHA and Bevacizumab
Hide Description To determine the clinical response rate of SAHA and Bevacizumab in patients with metastatic renal cell carcinoma.
Time Frame 7 years
Outcome Measure Data Not Reported
Time Frame 7 years
Adverse Event Reporting Description Adverse events were assessed through a regular investigator assessment
 
Arm/Group Title Arm I
Hide Arm/Group Description

Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.

Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.

vorinostat: Given orally

bevacizumab: Given IV

All-Cause Mortality
Arm I
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Arm I
Affected / at Risk (%) # Events
Total   3/37 (8.11%)    
Blood and lymphatic system disorders   
thrombocytopenia  1  1/37 (2.70%)  1
Nervous system disorders   
dizziness  1  1/37 (2.70%)  1
Respiratory, thoracic and mediastinal disorders   
pulmonary embolism  1  1/37 (2.70%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I
Affected / at Risk (%) # Events
Total   22/37 (59.46%)    
Gastrointestinal disorders   
nausea  1  17/37 (45.95%)  17
anorexia  1  16/37 (43.24%)  16
diarrhea  1  13/37 (35.14%)  13
Hepatobiliary disorders   
elevated creatinine  1  13/37 (35.14%)  13
Nervous system disorders   
fatigue  1  22/37 (59.46%)  22
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Carducci, MD
Organization: Johns Hopkins University
Phone: 410-614-6337
EMail: carducci@jhmi.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00324870    
Other Study ID Numbers: NCI-2009-00093
NCI-2009-00093 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NA 00001107
NCI-6884
JHOC-J0570
CDR0000467800
6884
JHOC-00001107
J0570
IRB #NA 00001107, SKCCC J0570 ( Other Identifier: Johns Hopkins University/Sidney Kimmel Cancer Center )
6884 ( Other Identifier: CTEP )
P30CA006973 ( U.S. NIH Grant/Contract )
U01CA062491 ( U.S. NIH Grant/Contract )
U01CA070095 ( U.S. NIH Grant/Contract )
First Submitted: May 10, 2006
First Posted: May 11, 2006
Results First Submitted: August 10, 2015
Results First Posted: September 9, 2015
Last Update Posted: January 13, 2016