Trial Outcomes & Findings for Gefitinib and Etoposide in Treating Patients With Advanced Prostate Cancer That Did Not Respond to Hormone Therapy (NCT NCT00483561)

Last Updated: 2023-09-13

Results Overview

If there is at least 1 response, then 7 additional patients will be enrolled. If there are 4 or more responders overall, then the combination will be considered active and warrant further study. Overall response rate (ORR) is defined as the proportion of patients who have a partial or complete response to therapy.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

Approximately 3 years

Results posted on

2023-09-13

Participant Flow

Participant milestones

Participant milestones
Measure	Gefitinib Plus Etoposide Gefitinib plus etoposide: Gefitinib 250 mg p.o. daily, starting on Day 1 and taken on a continuous basis throughout the trial with Etoposide-50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple). Patients with stable disease will be treated for 2 additional cycles beyond maximum response, for a maximum of 6 cycles. Restaging will be performed every 2 cycles. After completion of treatment, patients will continue to be followed for survival.
Overall Study STARTED	26
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gefitinib and Etoposide in Treating Patients With Advanced Prostate Cancer That Did Not Respond to Hormone Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gefitinib Plus Etoposide n=26 Participants Gefitinib plus etoposide: Gefitinib 250 mg p.o. daily, starting on Day 1 and taken on a continuous basis throughout the trial with Etoposide-50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple). Patients with stable disease will be treated for 2 additional cycles beyond maximum response, for a maximum of 6 cycles. Restaging will be performed every 2 cycles. After completion of treatment, patients will continue to be followed for survival.
Age, Customized Number of subjects 19 years of age and older	26 Participants n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	26 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	26 Participants n=99 Participants

PRIMARY outcome

Timeframe: Approximately 3 years

Population: Fifteen subjects were evaluable. A total of 26 subjects were consented; two were screen failures. Nine subjects were not evaluable due to coming off study prior to reaching the point of evaluation (2 cycles).

Outcome measures

Outcome measures
Measure	Gefitinib Plus Etoposide n=15 Participants Gefitinib plus etoposide: Gefitinib 250 mg p.o. daily, starting on Day 1 and taken on a continuous basis throughout the trial with Etoposide-50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple). Patients with stable disease will be treated for 2 additional cycles beyond maximum response, for a maximum of 6 cycles. Restaging will be performed every 2 cycles. After completion of treatment, patients will continue to be followed for survival.
Overall Response Rate as Measured by RECIST Criteria and PSA Criteria Stable Disease (by RECIST criteria)	5 Participants
Overall Response Rate as Measured by RECIST Criteria and PSA Criteria Partial Responder (by PSA criteria)	1 Participants

SECONDARY outcome

Timeframe: At every cycle

Population: Evaluation of this data is not possible as the investigator performing the analysis has left the study center prior to completing the analysis and data was not provided.

Outcome measures

Outcome data not reported

Adverse Events

Gefitinib Plus Etoposide

Serious events: 7 serious events

Other events: 4 other events

Deaths: 14 deaths

Serious adverse events

Serious adverse events
Measure	Gefitinib Plus Etoposide n=26 participants at risk Gefitinib 250 mg p.o. daily, starting on Day 1and taken on a continuous basis throughout the trial. Etoposide 50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple). Gefitinib plus etoposide: Gefitinib 250 mg p.o. daily, starting on Day 1and taken on a continuous basis throughout the trial with Etoposide 50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple).
Vascular disorders Vascular disorders - Other, specify	3.8% 1/26 • Number of events 1 • 52 months
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	3.8% 1/26 • Number of events 1 • 52 months
Blood and lymphatic system disorders Febrile neutropenia	3.8% 1/26 • Number of events 1 • 52 months
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	3.8% 1/26 • Number of events 1 • 52 months
Nervous system disorders Seizure	3.8% 1/26 • Number of events 1 • 52 months
Renal and urinary disorders Renal and urinary disorders - Other, specify	3.8% 1/26 • Number of events 1 • 52 months
Vascular disorders Hypotension	3.8% 1/26 • Number of events 1 • 52 months
Gastrointestinal disorders Nausea	3.8% 1/26 • Number of events 1 • 52 months
Gastrointestinal disorders Vomiting	3.8% 1/26 • Number of events 1 • 52 months
Gastrointestinal disorders Diarrhea	3.8% 1/26 • Number of events 1 • 52 months
General disorders General disorders and administration site conditions - Other, specify	3.8% 1/26 • Number of events 1 • 52 months
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.8% 1/26 • Number of events 1 • 52 months
Infections and infestations Sepsis	3.8% 1/26 • Number of events 1 • 52 months

Other adverse events

Other adverse events
Measure	Gefitinib Plus Etoposide n=26 participants at risk Gefitinib 250 mg p.o. daily, starting on Day 1and taken on a continuous basis throughout the trial. Etoposide 50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple). Gefitinib plus etoposide: Gefitinib 250 mg p.o. daily, starting on Day 1and taken on a continuous basis throughout the trial with Etoposide 50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple).
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	15.4% 4/26 • Number of events 5 • 52 months

Additional Information

Ralph Hauke, MD

University of Nebraska Medical Center

Phone: 402-354-8124

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place