Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 69 of 112 for:    acyclovir

Phase 2 Trial of Carfilzomib for Metastatic Castration-resistant Prostate Cancer Following Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02047253
Recruitment Status : Completed
First Posted : January 28, 2014
Results First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Guru Sonpavde, MD, University of Alabama at Birmingham

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Castration-resistant Prostate Cancer
Interventions Drug: Carfilzomib
Drug: Dexamethasone
Drug: Acyclovir
Enrollment 28
Recruitment Details Protocol Open to Accrual: April 2014, Primary Completion Date: June 2017 and Study Completion Date: July 14, 2017. Recruitment location: University of Alabama at Birmingham (UAB) Comprehensive Cancer Center, Birmingham; Tulane University, New Orleans; Medical Center of Central Georgia, Macon, Georgia, Dana Farber Cancer Institute, Boston.
Pre-assignment Details  
Arm/Group Title Carfilzomib
Hide Arm/Group Description

Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient.

Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle.

Dexamethasone: Administered prior to administration of Study drug

Acyclovir: Administered orally twice daily

Period Title: Overall Study
Started 28
Completed 20
Not Completed 8
Reason Not Completed
Lost to Follow-up             8
Arm/Group Title Carfilzomib
Hide Arm/Group Description

Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient.

Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle.

Dexamethasone: Administered prior to administration of Study drug

Acyclovir: Administered orally twice daily

Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
<=18 years 0
Between 18 and 65 years 13
>=65 years 15
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female 0
Male 28
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
American Indian or Alaska Native 0
Asian 0
Native Hawaiian or Other Pacific Islander 0
Black or African American 6
White 22
More than one race 0
Unknown or Not Reported 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description The study will measure patient survival at 6 months but will continue to monitor overall survival as a secondary objective. The Kaplan-Meier method will be used.
Time Frame Baseline through 6 months for evaluating all patients
Hide Outcome Measure Data
Hide Analysis Population Description
8 patients did not complete treatment and were not included in the analysis.
Arm/Group Title Carfilzomib
Hide Arm/Group Description:

Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient.

Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle.

Dexamethasone: Administered prior to administration of Study drug

Acyclovir: Administered orally twice daily

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.0%
2.Primary Outcome
Title Overall Survival
Hide Description Outcome measure was completed by using a count of participants.
Time Frame From baseline through 36 months.
Hide Outcome Measure Data
Hide Analysis Population Description
8 patients did not complete treatment and were lost to follow up
Arm/Group Title Carfilzomib
Hide Arm/Group Description:

Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient.

Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle.

Dexamethasone: Administered prior to administration of Study drug

Acyclovir: Administered orally twice daily

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
11
  55.0%
3.Secondary Outcome
Title Number of Participants With Prostate-Specific Antigen (PSA) Changes
Hide Description PSA levels were collected at each visit on the day of treatment. Linear regression with PSA as the dependent variable and time as the dependent variable was performed.
Time Frame Baseline through 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
We were unable to collect blood specimen for PSA analysis for 1 patient.
Arm/Group Title Carfilzomib
Hide Arm/Group Description:

Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient.

Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle.

Dexamethasone: Administered prior to administration of Study drug

Acyclovir: Administered orally twice daily

Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
3
  11.1%
4.Secondary Outcome
Title Number of Participants With Circulating Tumor Cell (CTC) Decline Over Three Time Points (Before Study Initiation, Day 1 of Cycles 2 and 4
Hide Description

The CTC marker will be used to evaluate efficacy of response to treatment. CTC changes will include changes from unfavorable (less than or equal to 5/7.5 ml) to favorable and declines by >30%.

Three collections: before study initiation, Day 1 of Cycles 2 and 4

Time Frame Baseline through 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient did not have blood draw. 27 patients had blood draws for CTC enumeration across baseline, Cycle 2 day 1 and cycle 4 day 1.
Arm/Group Title Carfilzomib
Hide Arm/Group Description:

Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient.

Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle.

Dexamethasone: Administered prior to administration of Study drug

Acyclovir: Administered orally twice daily

Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
CTC decline
3
  11.1%
CTC increased or No change/decline in CTC levels
24
  88.9%
5.Secondary Outcome
Title Assessment of Toxicities
Hide Description

Hematologic and non-hematologic toxicities will be graded. The new international criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) will serve as the guideline.

On Day 1 of each cycle (4 weeks) for the duration of treatment and then 30 days following the last treatment

Time Frame Baseline through 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
All serious adverse events and > grade 3 toxicities were reported for patients who received treatment with Carfilzomib
Arm/Group Title Carfilzomib
Hide Arm/Group Description:

Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient.

Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle.

Dexamethasone: Administered prior to administration of Study drug

Acyclovir: Administered orally twice daily

Overall Number of Participants Analyzed 28
Measure Type: Count of Participants
Unit of Measure: Participants
Anemia (>= Grade 3 or 4)
3
  10.7%
Hypertension (>= Grade 3 or 4)
2
   7.1%
Time Frame Adverse event data were collected over 36 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Carfilzomib
Hide Arm/Group Description

Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient.

Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle.

Dexamethasone: Administered prior to administration of Study drug

Acyclovir: Administered orally twice daily

All-Cause Mortality
Carfilzomib
Affected / at Risk (%)
Total   6/28 (21.43%)    
Show Serious Adverse Events Hide Serious Adverse Events
Carfilzomib
Affected / at Risk (%) # Events
Total   5/28 (17.86%)    
Blood and lymphatic system disorders   
Anemia *  3/28 (10.71%)  3
Cardiac disorders   
Hypertension *  2/28 (7.14%)  2
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Carfilzomib
Affected / at Risk (%) # Events
Total   0/28 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Pam Dixon, RN, BSN, OCN
Organization: University of Alabama at Birmingham
Phone: 205-975-9875
Responsible Party: Guru Sonpavde, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02047253     History of Changes
Other Study ID Numbers: F130725012 (UAB 1336)
First Submitted: January 20, 2014
First Posted: January 28, 2014
Results First Submitted: August 29, 2018
Results First Posted: December 19, 2018
Last Update Posted: December 19, 2018