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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-0062 | Other Identifier | Institutional Review Board | |
| NCI-2011-03640 | Registry Identifier | NCI Trial ID | |
| A535900 | Other Identifier | UW Madison | |
| SMPH\ONCOLOGY\ONCOLOGY | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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The purpose of this study is to determine the feasibility of giving standard TC chemotherapy on a dose dense schedule (ddTC) as well as evaluating the nature and frequency of ddTC side effects.
A standard chemotherapy treatment option for breast cancer after surgery (adjuvant therapy) is docetaxel + cyclophosphamide (TC). This study looks at a different schedule for giving the same adjuvant chemotherapy so that treatment can be completed faster (in 8 weeks rather than 12 weeks). This study uses a growth factor drug, pegfilgrastim, to help build blood cells that are lowered because of chemotherapy, making it possible to receive TC treatment every 2 weeks (referred to as "dose dense TC" or "ddTC") instead of the standard 3 week schedule. The main study procedures are blood draws, chemotherapy treatment, physical exams, and pegfilgrastim injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose dense TC + pegfilgrastim | Experimental | Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel + cyclophosphamide + pegfilgrastim | Drug | docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility for Dose-dense TC Therapy: Number of Participants Receiving at Least 90% of Total Dose of Therapy | Evaluate feasibility of delivering 4 cycles (1 cycle = 2 weeks) of docetaxel and cyclophosphamide (TC) on a dose-dense (q2week) schedule with pegfilgrastim support. This regimen will be referred to as dose-dense (dd)TC. Feasibility defined by at least 60% of patients receiving 90% of the total dose of therapy within 10 weeks. | 4 cycles each 2 weeks in length for a total of 8 weeks, up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Febrile Neutropenia | Neutropenic fever was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy. | Up to 10 weeks |
| Incidence of Neuropathy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amye J Tevaarwerk, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24342730 | Result | Burkard ME, Wisinski KB, Njiaju UO, Donohue S, Hegeman R, Stella A, Mansky P, Shah V, Goggins T, Qamar R, Dietrich L, Kim K, Traynor AM, Tevaarwerk AJ. Feasibility of 4 cycles of docetaxel and cyclophosphamide every 14 days as an adjuvant regimen for breast cancer: a Wisconsin Oncology Network study. Clin Breast Cancer. 2014 Jun;14(3):205-11. doi: 10.1016/j.clbc.2013.10.018. Epub 2013 Oct 26. |
| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
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The study was performed through the Wisconsin Oncology Network, a regional oncology network, at a combination of academic and community practice sites. Patients were enrolled between June 2011 and June 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Dense TC + Pegfilgrastim | Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Women with early stage breast cancer.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Dense TC + Pegfilgrastim | Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Feasibility for Dose-dense TC Therapy: Number of Participants Receiving at Least 90% of Total Dose of Therapy | Evaluate feasibility of delivering 4 cycles (1 cycle = 2 weeks) of docetaxel and cyclophosphamide (TC) on a dose-dense (q2week) schedule with pegfilgrastim support. This regimen will be referred to as dose-dense (dd)TC. Feasibility defined by at least 60% of patients receiving 90% of the total dose of therapy within 10 weeks. | Of 42 participants, 41 were evaluable for outcome measure analysis. | Posted | Number | participants | 4 cycles each 2 weeks in length for a total of 8 weeks, up to 10 weeks |
|
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Toxicity assessments were made one day 1 of each cycle, and as indicated clinically.
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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 | Dose Dense TC + Pegfilgrastim | Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amyé Tevaarwerk | University of Wisconsin Carbone Cancer Center | 608-262-2837 | at4@medicine.wisc.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D003520 | Cyclophosphamide |
| C455861 | pegfilgrastim |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
Neuropathy was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy.
| Up to 10 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pre- vs. Postmenopausal | Count of Participants | Participants |
|
| Staging Criteria | Participants were staged according to the American Joint Committee on Cancer (AJCC) staging manual. Node-negative: cancer has not spread to the lymph nodes Node-positive: cancer that has spread to the lymph nodes T1 and T2 refer to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. | Count of Participants | Participants |
|
| Receptor Status | Count of Participants | Participants |
|
| Final Surgery | Count of Participants | Participants |
|
|
|
| Secondary | Incidence of Febrile Neutropenia | Neutropenic fever was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy. | Of 42 participants, 41 were evaluable for outcome measure analysis. | Posted | Count of Participants | Participants | Up to 10 weeks |
|
|
|
| Secondary | Incidence of Neuropathy | Neuropathy was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy. | Of 42 participants, 41 were evaluable for outcome measure analysis. | Posted | Count of Participants | Participants | Up to 10 weeks |
|
|
|
| 4 |
| 42 |
| 42 |
| 42 |
| Perforation, GI | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthritis (non-septic) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Auditory/Ear - Ear pain | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Autoimmune reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cytokine release syndrome/acute infusion reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dermatology/Skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Distension/bloating, abdominal | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry eye syndrome | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema: limb | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Febrile neutropenia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flushing | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastritis (including bile reflux gastritis) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemorrhage, pulmonary/upper respiratory - Nose | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemorrhage/Bleeding | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hot flashes/flushes | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypothermia | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Injection site reaction/extravasation changes | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Irregular menses (change from baseline) | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mood alteration - Anxiety | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis/stomatitis (clinical exam) - Oral cavity | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nasal cavity/paranasal sinus reactions | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neurology - Other | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neuropathy: motor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neuropathy: sensory | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ocular/Visual - Itchy eyes | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Perforation, GI - Colon | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Phlebitis (including superficial thrombosis) | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Photosensitivity | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pulmonary/Upper Respiratory - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Renal/Genitourinary - Dysuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Supraventricular and nodal arrhythmia - Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Supraventricular and nodal arrhythmia - Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sweating (diaphoresis) | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Taste alteration (dysgeusia) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vaginal mucositis | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vision-blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Watery eye (epiphora, tearing) | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Weight gain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Wound complication, non-infectious | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
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| D017437 |
| Skin and Connective Tissue Diseases |
| 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 |