Trial Outcomes & Findings for Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients (NCT NCT01882985)
NCT ID: NCT01882985
Last Updated: 2021-01-05
Results Overview
To define the prostate-specific antigen (PSA) response rate according to the criteria of Bubley, et al. in subjects treated with a combination of docetaxel and lycopene. Per criteria of Bubley, et al., PSA response rate is defined the number of subjects who achieve a \>50% decline in PSA from baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Up to week 12 of therapy
Results posted on
2021-01-05
Participant Flow
Participant milestones
| Measure |
Treatment (Docetaxel and Lycopene)
Patients receive docetaxel IV over 1 hour on day 2 and lycopene PO once daily on days 1-21. Treatment repeats every 21days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Docetaxel: Given IV
Lycopene: Given PO
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Docetaxel and Lycopene)
Patients receive docetaxel IV over 1 hour on day 2 and lycopene PO once daily on days 1-21. Treatment repeats every 21days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Docetaxel: Given IV
Lycopene: Given PO
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients
Baseline characteristics by cohort
| Measure |
Treatment (Docetaxel and Lycopene)
n=14 Participants
Patients receive docetaxel IV over 1 hour on day 2 and lycopene PO once daily on days 1-21. Treatment repeats every 21days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Docetaxel: Given IV
Lycopene: Given PO
|
|---|---|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to week 12 of therapyPopulation: One patient was inevaluable due to lost to follow up and one patient withdrew consent.
To define the prostate-specific antigen (PSA) response rate according to the criteria of Bubley, et al. in subjects treated with a combination of docetaxel and lycopene. Per criteria of Bubley, et al., PSA response rate is defined the number of subjects who achieve a \>50% decline in PSA from baseline.
Outcome measures
| Measure |
Treatment (Docetaxel and Lycopene)
n=12 Participants
Patients receive docetaxel IV over 1 hour on day 2 and lycopene PO once daily on days 1-21. Treatment repeats every 21days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Docetaxel: Given IV
Lycopene: Given PO
|
|---|---|
|
Proporation of Subjects Achieving Partial Response, Stable Disease or Progressive Disease Based on PSA Response Rates
Partial Response (PR)
|
9 Participants
|
|
Proporation of Subjects Achieving Partial Response, Stable Disease or Progressive Disease Based on PSA Response Rates
Stable Disease (SD)
|
2 Participants
|
|
Proporation of Subjects Achieving Partial Response, Stable Disease or Progressive Disease Based on PSA Response Rates
Progressive Disease (PD)
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Data was not collected for this objective.
The percent of subjects achieving an objective response by RECIST criteria in either visceral or lymph node metastases, and the percent achieving clinical complete disappearance of disease at any site, will be recorded.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Mean time to PSA progression
The definition of time to PSA progression is the date (after the initiation of chemotherapy on day 2) that a 25% or greater increase, and an absolute increase of 2ng/mL or more, from the nadir PSA is documented. If there is no decrease in PSA following chemotherapy, then PSA progression is the date for documentation of a 25% increase from the baseline value along with an increase in absolute value of 2ng/mL or more.
Outcome measures
| Measure |
Treatment (Docetaxel and Lycopene)
n=12 Participants
Patients receive docetaxel IV over 1 hour on day 2 and lycopene PO once daily on days 1-21. Treatment repeats every 21days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Docetaxel: Given IV
Lycopene: Given PO
|
|---|---|
|
Time to PSA Progression
|
335 days
Standard Deviation 350.1
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Data was not collected for this outcome measure.
The percentage of subjects experiencing grade 3-4 hematologic and non-hematologic toxicity will be recorded, as well as the reason for ending treatment. This outcome measure was not collected due to lack of funding.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Docetaxel and Lycopene)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Treatment (Docetaxel and Lycopene)
n=14 participants at risk
Patients receive docetaxel IV over 1 hour on day 2 and lycopene PO once daily on days 1-21. Treatment repeats every 21days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Docetaxel: Given IV
Lycopene: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Severe Neutropenia
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Cardiac disorders
Cardiac Arrhythmia
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
Other adverse events
| Measure |
Treatment (Docetaxel and Lycopene)
n=14 participants at risk
Patients receive docetaxel IV over 1 hour on day 2 and lycopene PO once daily on days 1-21. Treatment repeats every 21days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Docetaxel: Given IV
Lycopene: Given PO
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
21.4%
3/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Immune system disorders
Alopecia
|
21.4%
3/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
General disorders
Fatigue
|
57.1%
8/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
2/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Skin and subcutaneous tissue disorders
Onchomychosis
|
35.7%
5/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
General disorders
Insomnia
|
21.4%
3/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
4/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Injury, poisoning and procedural complications
Edema
|
21.4%
3/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
General disorders
Pain
|
21.4%
3/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
2/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
General disorders
Decreased Appetite
|
14.3%
2/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
General disorders
Cracked Tooth
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Skin and subcutaneous tissue disorders
Skin Changes
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Infections and infestations
Left Eye Conjunctivitis
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Psychiatric disorders
Depression
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
General disorders
Nausea
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Decrease taste
|
14.3%
2/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
General disorders
Dry Mouth
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
2/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
General disorders
Dehydration
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Nervous system disorders
Neuropathy
|
14.3%
2/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Blood and lymphatic system disorders
Proteinuria
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
General disorders
Confusion
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Vascular disorders
Hemorrhoids
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
General disorders
Ecchymoses
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
General disorders
Blurred Vision
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
General disorders
Hot Flashes
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
General disorders
Dizziness
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
2/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Blood and lymphatic system disorders
Hypertension
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis
|
7.1%
1/14 • 86 days. Participants can then choose to continue treatment beyond this point until disease progression.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place