Trial Outcomes & Findings for Multicenter Study of Pharmacokinetic-Guided Docetaxel in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (NCT NCT02502864)
NCT ID: NCT02502864
Last Updated: 2020-09-11
Results Overview
Rate of PK guided dosing of docetaxel chemotherapy improving the ability to achieve a targeted AUC ( 2.5-3.7 mg\*hr/L) within 4 cycles of therapy in patients \> 65 years of age with breast cancer receiving TC (docetaxel and cyclophosphamide) as compared with historical non-PK guided therapy from patients receiving a similar regimen.
COMPLETED
PHASE4
9 participants
Cycle 4 - Up to 6 months
2020-09-11
Participant Flow
Participants were enrolled at Moffitt Cancer Center, February 2016 through June 2017.
Participant milestones
| Measure |
Standard of Care + Surveys
Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys. All participants will receive TC for cycle 1 with subsequent cycles repeated every 3 weeks for a total of 4 cycles. All initial dosing will be based on actual body weight and height. Participants will receive up to 4 doses of chemotherapy. Following their 4th dose of chemotherapy, or the last dose of chemotherapy in which blood level monitoring was performed, participants will be assessed for side effects from the chemotherapy and complete their final written 53 question survey about their quality of life.
Standard of Care: Docetaxel: Pharmacokinetic(PK)-guided docetaxel. Cycle 1: 75 mg/m\^2, intravenously (IV) on Day 1 for 60 minutes. Beginning with cycle 2, the docetaxel dose will be individually adjusted before each cycle.
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|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Standard of Care + Surveys
Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys. All participants will receive TC for cycle 1 with subsequent cycles repeated every 3 weeks for a total of 4 cycles. All initial dosing will be based on actual body weight and height. Participants will receive up to 4 doses of chemotherapy. Following their 4th dose of chemotherapy, or the last dose of chemotherapy in which blood level monitoring was performed, participants will be assessed for side effects from the chemotherapy and complete their final written 53 question survey about their quality of life.
Standard of Care: Docetaxel: Pharmacokinetic(PK)-guided docetaxel. Cycle 1: 75 mg/m\^2, intravenously (IV) on Day 1 for 60 minutes. Beginning with cycle 2, the docetaxel dose will be individually adjusted before each cycle.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Multicenter Study of Pharmacokinetic-Guided Docetaxel in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide
Baseline characteristics by cohort
| Measure |
Standard of Care + Surveys
n=9 Participants
Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys.
|
|---|---|
|
Age, Continuous
|
72 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
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9 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Cycle 4 - Up to 6 monthsPopulation: All participants evaluable at time of analysis.
Rate of PK guided dosing of docetaxel chemotherapy improving the ability to achieve a targeted AUC ( 2.5-3.7 mg\*hr/L) within 4 cycles of therapy in patients \> 65 years of age with breast cancer receiving TC (docetaxel and cyclophosphamide) as compared with historical non-PK guided therapy from patients receiving a similar regimen.
Outcome measures
| Measure |
Standard of Care + Surveys
n=8 Participants
Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys.
|
|---|---|
|
Rate of Achieving Targeted Area Under the Curve (AUC)
AUC mg*hr/L: 2.5-3.7
|
5 Participants
|
|
Rate of Achieving Targeted Area Under the Curve (AUC)
AUC mg*hr/L: <2.5
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: All participants.
The incidence of grade 3 and 4 neutropenia and febrile neutropenia in cycles following PK adjustment (cycles 2-4) will be compared with cycle 1 and historical non-PK guided therapy using the Wilcoxon-Rank sum assessment.
Outcome measures
| Measure |
Standard of Care + Surveys
n=9 Participants
Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys.
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|---|---|
|
Incidence of Grade 3 and 4 Neutropenia and Febrile Neutropenia
Participants with Grade 3 or 4 neutropenia
|
2 Participants
|
|
Incidence of Grade 3 and 4 Neutropenia and Febrile Neutropenia
Participants with Febrile neutropenia
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0 Participants
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SECONDARY outcome
Timeframe: Baseline and Post Cycle 1Population: Descriptive analysis was planned for 52 participants. Due to the small number of participants enrolled, analyzing additional correlations was not possible.
The Chemotherapy Risk Assessment Scale for High-Age Patients (CRASH) score will be reported as ordinal data (low, intermediate-low, intermediate-high, or high risk).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Post Cycle 1Population: Descriptive analysis was planned for 52 participants. Due to the small number of participants enrolled, analyzing additional correlations was not possible.
The Instrumental Activities of Daily Living (IADL) total score will be reported as binomial data (greater or less than 26 based on how it is incorporated into the CRASH score).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Post Cycle 1Population: Descriptive analysis was planned for 52 participants. Due to the small number of participants enrolled, analyzing additional correlations was not possible.
The Cumulative Illness Rating Scale for Geriatrics (CIRS-G) will be reported as discrete data out of a possible score of 65. The Wilcoxon-Rank sum and Chi-squared tests will be used as appropriate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 6 monthsPopulation: Descriptive analysis was planned for 52 participants. Due to the small number of participants enrolled, analyzing additional correlations was not possible.
The relationship between PK-guided docetaxel patient PK profiles and the Function Assessment of Cancer Therapy (FACT) Taxane and Breast Cancer scores will be described.
Outcome measures
Outcome data not reported
Adverse Events
Standard of Care + Surveys
Serious adverse events
| Measure |
Standard of Care + Surveys
n=9 participants at risk
Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys.
|
|---|---|
|
General disorders
Fatigue
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
General disorders
Non-cardiac chest pain
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Infections and infestations
Sepsis
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Nervous system disorders
Syncope
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Vascular disorders
Thromboembolic event
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
Other adverse events
| Measure |
Standard of Care + Surveys
n=9 participants at risk
Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
66.7%
6/9 • Number of events 6 • 1 year, 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
55.6%
5/9 • Number of events 8 • 1 year, 9 months
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • Number of events 4 • 1 year, 9 months
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
3/9 • Number of events 3 • 1 year, 9 months
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Gastrointestinal disorders
Oral pain
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
General disorders
Fatigue
|
100.0%
9/9 • Number of events 15 • 1 year, 9 months
|
|
General disorders
Edema limbs
|
33.3%
3/9 • Number of events 3 • 1 year, 9 months
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
6/9 • Number of events 7 • 1 year, 9 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
55.6%
5/9 • Number of events 5 • 1 year, 9 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
66.7%
6/9 • Number of events 6 • 1 year, 9 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Investigations
Neutrophil count decreased
|
44.4%
4/9 • Number of events 6 • 1 year, 9 months
|
|
Investigations
White blood cell decreased
|
44.4%
4/9 • Number of events 4 • 1 year, 9 months
|
|
Investigations
Alkaline phosphatase increased
|
22.2%
2/9 • Number of events 2 • 1 year, 9 months
|
|
Investigations
Lymphocyte count decreased
|
22.2%
2/9 • Number of events 2 • 1 year, 9 months
|
|
Investigations
Platelet count decreased
|
22.2%
2/9 • Number of events 2 • 1 year, 9 months
|
|
Investigations
Creatinine increased
|
11.1%
1/9 • Number of events 2 • 1 year, 9 months
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9 • Number of events 2 • 1 year, 9 months
|
|
Nervous system disorders
Headache
|
22.2%
2/9 • Number of events 2 • 1 year, 9 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Nervous system disorders
Syncope
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
3/9 • Number of events 3 • 1 year, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
22.2%
2/9 • Number of events 2 • 1 year, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
1/9 • Number of events 2 • 1 year, 9 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Vascular disorders
Hypotension
|
33.3%
3/9 • Number of events 3 • 1 year, 9 months
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Eye disorders
Dry eye
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Eye disorders
Watering eyes
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Infections and infestations
Papulopustular rash
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Infections and infestations
Sepsis
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Immune system disorders
Allergic reaction
|
11.1%
1/9 • Number of events 2 • 1 year, 9 months
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
|
Renal and urinary disorders
Hematuria
|
11.1%
1/9 • Number of events 1 • 1 year, 9 months
|
Additional Information
Christine M. Walko, Pharm.D., BCOP
H. Lee Moffitt Cancer Center and Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place