Trial Outcomes & Findings for Phase II Metronomic Dosing, Etoposide, Cyclophosphamide, D0 Prostate Cancer (NCT NCT00176605)
NCT ID: NCT00176605
Last Updated: 2014-05-20
Results Overview
The PSA response rate is the percentage of patients who have a PSA response. A PSA response will be considered a PSA decline of at least 50% must be confirmed by a second PSA value four or more weeks later. The reference PSA for these declines should be a PSA measured within 2 weeks prior to the initiation of therapy. Patients may not demonstrate clinical or radiographic evidence of disease progression during this period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
5 years
Results posted on
2014-05-20
Participant Flow
Subjects were recruited from the Cancer Institute of New Jersey (a comprehensive cancer center at an academic institution) and Robert Wood Johnson University Hospital at Hamilton (a community hospital) from August 2005 through May 2008.
Participant milestones
| Measure |
Arm 1 (Etoposide + Cyclophosphamide)
Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.
Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Arm 1 (Etoposide + Cyclophosphamide)
Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.
Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Phase II Metronomic Dosing, Etoposide, Cyclophosphamide, D0 Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm 1 (Etoposide + Cyclophosphamide)
n=15 Participants
Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.
Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=93 Participants
|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 8.0 • n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 5 yearsThe PSA response rate is the percentage of patients who have a PSA response. A PSA response will be considered a PSA decline of at least 50% must be confirmed by a second PSA value four or more weeks later. The reference PSA for these declines should be a PSA measured within 2 weeks prior to the initiation of therapy. Patients may not demonstrate clinical or radiographic evidence of disease progression during this period.
Outcome measures
| Measure |
Arm 1 (Etoposide + Cyclophosphamide)
n=13 Participants
Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.
Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration
|
|---|---|
|
PSA Response Rate
|
15.4 percentage of participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: No subjects experienced serious adverse events related to the intervention.
All patients who receive one dose of protocol therapy will be evaluable for toxicity. A total of 15 patients received at least one dose of protocol therapy. Adverse events are described in Adverse Event section.
Outcome measures
| Measure |
Arm 1 (Etoposide + Cyclophosphamide)
n=15 Participants
Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.
Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration
|
|---|---|
|
Toxicities Related to Chronic Administration of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer.
|
0 participants
|
Adverse Events
Arm 1 (Etoposide + Cyclophosphamide)
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 (Etoposide + Cyclophosphamide)
n=15 participants at risk
Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.
Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration
|
|---|---|
|
Cardiac disorders
Valvular heart disease
|
6.7%
1/15 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Ulcer, GI - Anus
|
6.7%
1/15 • Number of events 1 • 3 years
|
|
Infections and infestations
Infection with unknown ANC - appendix
|
6.7%
1/15 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Arm 1 (Etoposide + Cyclophosphamide)
n=15 participants at risk
Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.
Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
26.7%
4/15 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
20.0%
3/15 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
Anorexia
|
6.7%
1/15 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • 3 years
|
|
General disorders
Fatigue (astenia, lethary, malaise)
|
40.0%
6/15 • Number of events 6 • 3 years
|
|
General disorders
Constitution Symptoms (Other)
|
6.7%
1/15 • Number of events 1 • 3 years
|
|
General disorders
Rigors/chills
|
6.7%
1/15 • Number of events 1 • 3 years
|
|
General disorders
Sweating (diaphoresis)
|
6.7%
1/15 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
13.3%
2/15 • Number of events 2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
6.7%
1/15 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
6.7%
1/15 • Number of events 2 • 3 years
|
|
General disorders
Pain/ - head/headache
|
26.7%
4/15 • Number of events 4 • 3 years
|
|
General disorders
Pain - chest/thorax NOS
|
6.7%
1/15 • Number of events 1 • 3 years
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Mood alteration - depression
|
6.7%
1/15 • Number of events 2 • 3 years
|
|
Nervous system disorders
Neuropathy: sensor
|
6.7%
1/15 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
6.7%
1/15 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
6.7%
1/15 • Number of events 1 • 3 years
|
Additional Information
Dr. Mark Stein
Rutgers Cancer Institute of New Jersey
Phone: 732-235-8675
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place