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| Name | Class |
|---|---|
| Saladax Biomedical, Inc. | INDUSTRY |
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The purpose of this study is to adjust the amount of docetaxel participants receive based on the level of docetaxel measured in their blood. This method of dose adjustment is called pharmacokinetic (PK)-adjusted docetaxel. The researchers believe that adjusting the dose of docetaxel using this method will lessen the side effects associated with docetaxel in cancer treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care + Surveys | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care: Docetaxel | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Achieving Targeted Area Under the Curve (AUC) | 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. | Cycle 4 - Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Grade 3 and 4 Neutropenia and Febrile Neutropenia | 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. | Up to 6 months |
| Association Between Scores - Chemotherapy Risk Assessment Scale for High-Age Patients |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Patient Profiles and Function Assessment of Cancer Therapy (FACT) Scores | 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. | Up to 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Walko, Pharm.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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Participants were enrolled at Moffitt Cancer Center, February 2016 through June 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 2, 2015 |
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| Standard of Care: Cyclophosphamide | Drug | Cycle 1: 600 mg/m^2, via IV on Day 1 for 30 minutes. The cyclophosphamide dose will not be changed unless dictated by toxicity. |
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| Function Assessment of Cancer Therapy (FACT) Surveys | Other | Participants will complete the FACT-Taxane and FACT-Breast quality of life assessment written surveys at baseline, during each chemotherapy cycle, and 3-5 weeks following the last cycle in which PK monitoring was performed. |
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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). |
| Baseline and Post Cycle 1 |
| Association Between Scores - Instrumental Activities of Daily Living | 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). | Baseline and Post Cycle 1 |
| Association Between Scores - Cumulative Illness Rating Scale for Geriatrics | 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. | Baseline and Post Cycle 1 |
| COMPLETED |
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| NOT COMPLETED |
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All participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care + Surveys | Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Achieving Targeted Area Under the Curve (AUC) | 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. | All participants evaluable at time of analysis. | Posted | Count of Participants | Participants | Cycle 4 - Up to 6 months |
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| Secondary | Incidence of Grade 3 and 4 Neutropenia and Febrile Neutropenia | 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. | All participants. | Posted | Count of Participants | Participants | Up to 6 months |
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| Secondary | Association Between Scores - Chemotherapy Risk Assessment Scale for High-Age Patients | 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). | Descriptive analysis was planned for 52 participants. Due to the small number of participants enrolled, analyzing additional correlations was not possible. | Posted | Baseline and Post Cycle 1 |
|
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| Secondary | Association Between Scores - Instrumental Activities of Daily Living | 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). | Descriptive analysis was planned for 52 participants. Due to the small number of participants enrolled, analyzing additional correlations was not possible. | Posted | Baseline and Post Cycle 1 |
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| Secondary | Association Between Scores - Cumulative Illness Rating Scale for Geriatrics | 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. | Descriptive analysis was planned for 52 participants. Due to the small number of participants enrolled, analyzing additional correlations was not possible. | Posted | Baseline and Post Cycle 1 |
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| Other Pre-specified | Comparison of Patient Profiles and Function Assessment of Cancer Therapy (FACT) Scores | 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. | Descriptive analysis was planned for 52 participants. Due to the small number of participants enrolled, analyzing additional correlations was not possible. | Posted | Up to 6 months |
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1 year, 9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care + Surveys | Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys. | 0 | 9 | 3 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Sepsis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
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| Syncope | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Salivary duct inflammation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Edema limbs | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| White blood cell decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Creatinine increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Syncope | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Dry eye | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Watering eyes | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Papulopustular rash | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
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| Sepsis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
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| Allergic reaction | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
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Recruiting ended early due to slow enrollment. Larger studies may help elucidate a more optimal AUC range for senior adults receiving docetaxel as part of the TC regimen for breast cancer to balance both toxicity and efficacy.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine M. Walko, Pharm.D., BCOP | H. Lee Moffitt Cancer Center and Research Institute | 813-745-1519 | christine.walko@moffitt.org |
| Aug 13, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D003520 | Cyclophosphamide |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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