Trial Outcomes & Findings for Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT) (NCT NCT00094497)

Results Overview

participants who died among those randomized to first-line therapy

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

304 participants

Primary outcome timeframe

every 8 weeks until death up to 5 years

Results posted on

2016-09-21

Participant Flow

Participant milestones

Participant milestones
Measure	EDP-M etopodide, doxorubicin, cisplatin and mitotane Etoposide Doxorubicin Cisplatin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)	Sz-M streptozotocin and mitotane Streptozotocin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)
Overall Study STARTED	151	153
Overall Study Treated	148	149
Overall Study Received Second Line Therapy	84	101
Overall Study COMPLETED	151	153
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EDP-M n=151 Participants etopodide, doxorubicin, cisplatin and mitotane Etoposide Doxorubicin Cisplatin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)	Sz-M n=153 Participants streptozotocin and mitotane Streptozotocin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)	Total n=304 Participants Total of all reporting groups
Age, Customized >= 18 years	151 participants n=99 Participants	153 participants n=107 Participants	304 participants n=206 Participants
Sex: Female, Male Female	91 Participants n=99 Participants	92 Participants n=107 Participants	183 Participants n=206 Participants
Sex: Female, Male Male	60 Participants n=99 Participants	61 Participants n=107 Participants	121 Participants n=206 Participants
tumor stage III	0 participants n=99 Participants	1 participants n=107 Participants	1 participants n=206 Participants
tumor stage IV	151 participants n=99 Participants	152 participants n=107 Participants	303 participants n=206 Participants
ECOG 0	73 participants n=99 Participants	72 participants n=107 Participants	145 participants n=206 Participants
ECOG 1	64 participants n=99 Participants	60 participants n=107 Participants	124 participants n=206 Participants
ECOG 2	13 participants n=99 Participants	21 participants n=107 Participants	34 participants n=206 Participants
ECOG 4	1 participants n=99 Participants	0 participants n=107 Participants	1 participants n=206 Participants

PRIMARY outcome

Timeframe: every 8 weeks until death up to 5 years

participants who died among those randomized to first-line therapy

Outcome measures

Outcome measures
Measure	EDP-M n=151 Participants etopodide, doxorubicin, cisplatin and mitotane Etoposide Doxorubicin Cisplatin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)	Sz-M n=153 Participants streptozotocin and mitotane Streptozotocin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)
Overall Survival	108 participants	124 participants

SECONDARY outcome

Timeframe: every 8 weeks until progression or death up to 5 years

Outcome measures

Outcome measures
Measure	EDP-M n=151 Participants etopodide, doxorubicin, cisplatin and mitotane Etoposide Doxorubicin Cisplatin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)	Sz-M n=153 Participants streptozotocin and mitotane Streptozotocin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)
Progression-free Survival	5.0 months Interval 3.5 to 6.9	2.1 months Interval 2.04 to 2.33

SECONDARY outcome

Timeframe: baseline and 8 weeks

Population: participants with data on both time points

scale ranged from 0 to 100 with higher score meaning greater quality of life

Outcome measures

Outcome measures
Measure	EDP-M n=60 Participants etopodide, doxorubicin, cisplatin and mitotane Etoposide Doxorubicin Cisplatin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)	Sz-M n=39 Participants streptozotocin and mitotane Streptozotocin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)
Change in Quality of Life as Measured by QLQ-C30	-6.0 units on a scale Standard Deviation 21.4	-7.7 units on a scale Standard Deviation 25.6

SECONDARY outcome

Timeframe: every 8 weeks up to 5 years

RECIST 1.0 was used to evaluate response

Outcome measures

Outcome measures
Measure	EDP-M n=151 Participants etopodide, doxorubicin, cisplatin and mitotane Etoposide Doxorubicin Cisplatin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)	Sz-M n=153 Participants streptozotocin and mitotane Streptozotocin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)
Best Overall Response Rate complete response	2 participants	1 participants
Best Overall Response Rate disease-free by time of surgery	4 participants	2 participants
Best Overall Response Rate partial response	29 participants	11 participants
Best Overall Response Rate stable disease	53 participants	34 participants
Best Overall Response Rate progressive disease	43 participants	88 participants
Best Overall Response Rate did not receive treatment	3 participants	4 participants
Best Overall Response Rate could not be evaluated	17 participants	13 participants

SECONDARY outcome

Timeframe: every 8 weeks until progression (up to 5 years)

complete response or disease-free by time of surgery

Outcome measures

Outcome measures
Measure	EDP-M n=151 Participants etopodide, doxorubicin, cisplatin and mitotane Etoposide Doxorubicin Cisplatin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)	Sz-M n=153 Participants streptozotocin and mitotane Streptozotocin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)
Number of Disease-free Patients	6 participants	3 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: every 8 weeks until progression or until Dec 2010

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 11 time points in the first 12 weeks

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).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: every 8 weeks until progression or until Dec 2010

Outcome measures

Outcome data not reported

Adverse Events

EDP-M

Serious events: 86 serious events

Other events: 0 other events

Deaths: 0 deaths

Sz-M

Serious events: 62 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	EDP-M n=148 participants at risk etopodide, doxorubicin, cisplatin and mitotane Etoposide Doxorubicin Cisplatin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)	Sz-M n=149 participants at risk streptozotocin and mitotane Streptozotocin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)
Endocrine disorders adrenal insufficiency	3.4% 5/148 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported	0.67% 1/149 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported
Blood and lymphatic system disorders bone marrow toxicity	11.5% 17/148 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported	2.0% 3/149 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported
Vascular disorders cardiovascular or thromboembolic events	6.8% 10/148 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported	0.00% 0/149 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported
General disorders fatigue or general health deterioration	5.4% 8/148 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported	4.7% 7/149 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported
Gastrointestinal disorders gastrointestinal disorder	4.1% 6/148 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported	8.1% 12/149 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported
Hepatobiliary disorders impaired liver function	0.00% 0/148 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported	4.7% 7/149 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported
Renal and urinary disorders impaired renal function	0.68% 1/148 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported	4.0% 6/149 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported
Infections and infestations infection	6.8% 10/148 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported	2.7% 4/149 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported
Nervous system disorders neurologic toxicity	3.4% 5/148 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported	2.7% 4/149 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported
Respiratory, thoracic and mediastinal disorders respiratory disorder	6.1% 9/148 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported	3.4% 5/149 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported
General disorders Other	10.1% 15/148 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported	8.7% 13/149 • up to 5 years Other non-serious adverse events were not reliably collected and therefore not reported

Other adverse events

Adverse event data not reported

Additional Information

Martin Fassnacht

University Hospital of Wuerzburg, Germany

Phone: +49-931-201-39021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place