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Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)

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: NCT00094497
Recruitment Status : Completed
First Posted : October 20, 2004
Results First Posted : September 21, 2016
Last Update Posted : September 21, 2016
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Martin Fassnacht, Collaborative Group for Adrenocortical Carcinoma Treatment

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Adrenal Cortical
Interventions Drug: Etoposide
Drug: Doxorubicin
Drug: Cisplatin
Drug: Streptozotocin
Drug: Mitotane
Enrollment 304
Recruitment Details  
Pre-assignment Details  
Arm/Group Title EDP-M Sz-M
Hide Arm/Group Description

etopodide, doxorubicin, cisplatin and mitotane

Etoposide

Doxorubicin

Cisplatin

Mitotane

participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)

streptozotocin and mitotane

Streptozotocin

Mitotane

participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)

Period Title: Overall Study
Started 151 153
Treated 148 149
Received Second Line Therapy 84 101
Completed 151 153
Not Completed 0 0
Arm/Group Title EDP-M Sz-M Total
Hide Arm/Group Description

etopodide, doxorubicin, cisplatin and mitotane

Etoposide

Doxorubicin

Cisplatin

Mitotane

participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)

streptozotocin and mitotane

Streptozotocin

Mitotane

participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)

Total of all reporting groups
Overall Number of Baseline Participants 151 153 304
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
>= 18 years Number Analyzed 151 participants 153 participants 304 participants
151 153 304
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 153 participants 304 participants
Female
91
  60.3%
92
  60.1%
183
  60.2%
Male
60
  39.7%
61
  39.9%
121
  39.8%
tumor stage  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 153 participants 304 participants
III 0 1 1
IV 151 152 303
ECOG   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 153 participants 304 participants
0 73 72 145
1 64 60 124
2 13 21 34
4 1 0 1
[1]
Measure Description: Eastern Cooperative Oncology Group performance status score (ranges from 0, asymptomatic - 5, dead)
1.Primary Outcome
Title Overall Survival
Hide Description participants who died among those randomized to first-line therapy
Time Frame every 8 weeks until death up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EDP-M Sz-M
Hide Arm/Group Description:

etopodide, doxorubicin, cisplatin and mitotane

Etoposide

Doxorubicin

Cisplatin

Mitotane

participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)

streptozotocin and mitotane

Streptozotocin

Mitotane

participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)

Overall Number of Participants Analyzed 151 153
Measure Type: Number
Unit of Measure: participants
108 124
2.Secondary Outcome
Title Progression-free Survival
Hide Description [Not Specified]
Time Frame every 8 weeks until progression or death up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EDP-M Sz-M
Hide Arm/Group Description:

etopodide, doxorubicin, cisplatin and mitotane

Etoposide

Doxorubicin

Cisplatin

Mitotane

participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)

streptozotocin and mitotane

Streptozotocin

Mitotane

participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)

Overall Number of Participants Analyzed 151 153
Median (95% Confidence Interval)
Unit of Measure: months
5.0
(3.5 to 6.9)
2.1
(2.04 to 2.33)
3.Secondary Outcome
Title Change in Quality of Life as Measured by QLQ-C30
Hide Description scale ranged from 0 to 100 with higher score meaning greater quality of life
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
participants with data on both time points
Arm/Group Title EDP-M Sz-M
Hide Arm/Group Description:

etopodide, doxorubicin, cisplatin and mitotane

Etoposide

Doxorubicin

Cisplatin

Mitotane

participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)

streptozotocin and mitotane

Streptozotocin

Mitotane

participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)

Overall Number of Participants Analyzed 60 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.0  (21.4) -7.7  (25.6)
4.Secondary Outcome
Title Best Overall Response Rate
Hide Description RECIST 1.0 was used to evaluate response
Time Frame every 8 weeks up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EDP-M Sz-M
Hide Arm/Group Description:

etopodide, doxorubicin, cisplatin and mitotane

Etoposide

Doxorubicin

Cisplatin

Mitotane

participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)

streptozotocin and mitotane

Streptozotocin

Mitotane

participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)

Overall Number of Participants Analyzed 151 153
Measure Type: Number
Unit of Measure: participants
complete response 2 1
disease-free by time of surgery 4 2
partial response 29 11
stable disease 53 34
progressive disease 43 88
did not receive treatment 3 4
could not be evaluated 17 13
5.Secondary Outcome
Title Number of Disease-free Patients
Hide Description complete response or disease-free by time of surgery
Time Frame every 8 weeks until progression (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EDP-M Sz-M
Hide Arm/Group Description:

etopodide, doxorubicin, cisplatin and mitotane

Etoposide

Doxorubicin

Cisplatin

Mitotane

participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)

streptozotocin and mitotane

Streptozotocin

Mitotane

participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)

Overall Number of Participants Analyzed 151 153
Measure Type: Number
Unit of Measure: participants
6 3
6.Other Pre-specified Outcome
Title TTP of Both Regimens as Second Line Treatment in Case of Failure of the Other Initial Regime
Hide Description [Not Specified]
Time Frame every 8 weeks until progression or until Dec 2010
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Pharmakinetics of Mitotane (Substudy)
Hide Description To study the relationship between mitotane dose (daily and cumulative) and mitotane plasma concentrations using one of two pre-defined treatment regimens (high-dose and low-dose).
Time Frame 11 time points in the first 12 weeks
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Impact of Reaching Mitotane Blood Levels Between 14-20 mg/l in Both Arms on Survival and Overall Response Rate
Hide Description [Not Specified]
Time Frame every 8 weeks until progression or until Dec 2010
Outcome Measure Data Not Reported
Time Frame up to 5 years
Adverse Event Reporting Description Other non-serious adverse events were not reliably collected and therefore not reported
 
Arm/Group Title EDP-M Sz-M
Hide Arm/Group Description

etopodide, doxorubicin, cisplatin and mitotane

Etoposide

Doxorubicin

Cisplatin

Mitotane

participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)

streptozotocin and mitotane

Streptozotocin

Mitotane

participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)

All-Cause Mortality
EDP-M Sz-M
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
EDP-M Sz-M
Affected / at Risk (%) Affected / at Risk (%)
Total   86/148 (58.11%)   62/149 (41.61%) 
Blood and lymphatic system disorders     
bone marrow toxicity  1  17/148 (11.49%)  3/149 (2.01%) 
Endocrine disorders     
adrenal insufficiency  1  5/148 (3.38%)  1/149 (0.67%) 
Gastrointestinal disorders     
gastrointestinal disorder  1  6/148 (4.05%)  12/149 (8.05%) 
General disorders     
fatigue or general health deterioration  1  8/148 (5.41%)  7/149 (4.70%) 
Other  1  15/148 (10.14%)  13/149 (8.72%) 
Hepatobiliary disorders     
impaired liver function  1  0/148 (0.00%)  7/149 (4.70%) 
Infections and infestations     
infection  1  10/148 (6.76%)  4/149 (2.68%) 
Nervous system disorders     
neurologic toxicity  1  5/148 (3.38%)  4/149 (2.68%) 
Renal and urinary disorders     
impaired renal function  1  1/148 (0.68%)  6/149 (4.03%) 
Respiratory, thoracic and mediastinal disorders     
respiratory disorder  1  9/148 (6.08%)  5/149 (3.36%) 
Vascular disorders     
cardiovascular or thromboembolic events  1  10/148 (6.76%)  0/149 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
EDP-M Sz-M
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Martin Fassnacht
Organization: University Hospital of Wuerzburg, Germany
Phone: +49-931-201-39021
EMail: fassnacht_m@ukw.de
Layout table for additonal information
Responsible Party: Martin Fassnacht, Collaborative Group for Adrenocortical Carcinoma Treatment
ClinicalTrials.gov Identifier: NCT00094497    
Obsolete Identifiers: NCT00924144
Other Study ID Numbers: CO-ACT-001
First Submitted: October 19, 2004
First Posted: October 20, 2004
Results First Submitted: September 19, 2016
Results First Posted: September 21, 2016
Last Update Posted: September 21, 2016