Trial Outcomes & Findings for Combination Chemotherapy Followed by Surgery in Treating Patients With Localized Prostate Cancer (NCT NCT00017563)
NCT ID: NCT00017563
Last Updated: 2017-04-28
Results Overview
Number of participants that experienced 5-year freedom from Prostate Specific Antigen (PSA) recurrence (PSA \> 0.4 ng/ml confirmed by a second PSA that is higher than the first by any amount (2)) in men with high risk localized prostate cancer treated with neoadjuvant docetaxel/mitoxantrone followed by surgery.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
Every 3 months after surgery for up to 5 years.
Results posted on
2017-04-28
Participant Flow
Participant milestones
| Measure |
Docetaxel and Mitox
Drug: docetaxel
35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.
Drug: mitoxantrone hydrochloride
Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
56
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Chemotherapy Followed by Surgery in Treating Patients With Localized Prostate Cancer
Baseline characteristics by cohort
| Measure |
Docetaxel and Mitox
n=57 Participants
Drug: docetaxel
35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.
Drug: mitoxantrone hydrochloride
Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
61.56 years
STANDARD_DEVIATION 6.279 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 3 months after surgery for up to 5 years.Number of participants that experienced 5-year freedom from Prostate Specific Antigen (PSA) recurrence (PSA \> 0.4 ng/ml confirmed by a second PSA that is higher than the first by any amount (2)) in men with high risk localized prostate cancer treated with neoadjuvant docetaxel/mitoxantrone followed by surgery.
Outcome measures
| Measure |
Docetaxel and Mitox
n=57 Participants
Drug: docetaxel
35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.
Drug: mitoxantrone hydrochloride
Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.
|
|---|---|
|
Number of Participants With 5-year Freedom From Prostate Specific Antigen (PSA) Recurrence.
|
30 participants
|
Adverse Events
Docetaxel and Mitox
Serious events: 43 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel and Mitox
n=57 participants at risk
Drug: docetaxel
35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.
Drug: mitoxantrone hydrochloride
Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
31.6%
18/57
|
|
Blood and lymphatic system disorders
Leukopenia
|
36.8%
21/57
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.8%
1/57
|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
3/57
|
Other adverse events
| Measure |
Docetaxel and Mitox
n=57 participants at risk
Drug: docetaxel
35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.
Drug: mitoxantrone hydrochloride
Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.
|
|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
19.3%
11/57
|
|
Skin and subcutaneous tissue disorders
Dermatology-Skin Toxicity
|
5.3%
3/57
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
17.5%
10/57
|
|
Blood and lymphatic system disorders
Anemia
|
5.3%
3/57
|
|
General disorders
Fatigue
|
14.0%
8/57
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
8.8%
5/57
|
|
Eye disorders
Hyperlacrimation
|
7.0%
4/57
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
29.8%
17/57
|
|
General disorders
Taste Disturbance
|
7.0%
4/57
|
|
Eye disorders
Vision
|
5.3%
3/57
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place