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| Name | Class |
|---|---|
| Aventis Pharmaceuticals | INDUSTRY |
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RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving carboplatin together with docetaxel after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving carboplatin together with docetaxel works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive carboplatin IV on day 1 and docetaxel IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm Trial | Other | adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen | Feasibility was based on the percentage of patients completing four cycles of the carboplatin/docetaxel regimen to a high fraction of patients with curatively resected stage IIIIA non-small cell lung cancer within 12 weeks. | 12 weeks from initiating adjuvant therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Patterns of Recurrence in Patients Treated With This Regimen | Patterns were assessed with a staging chest computerized tomography (CT), bone or positron emission tomography (PET) scan and brain magnetic resonance imaging (MRI)/CT scan at recurrence. | Up to 5 years |
| Toxicity in Patients Treated With This Regimen |
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DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically confirmed non-small cell lung cancer
Must have undergone a complete resection
Must begin adjuvant chemotherapy within 8 weeks of surgical resection
PATIENT CHARACTERISTICS:
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Absolute neutrophil count ≥ 1,500/mm^3
Hemoglobin ≥ 8.0 g/dL
Platelet count ≥ 100,000/mm^3
Serum creatinine normal OR creatinine clearance ≥ 40 mL/min
Bilirubin normal
Alkaline phosphatase (AP), Aspartate aminotransferase (AST), and Alanine transaminase (ALT) must meet 1 of the following criteria:
Negative pregnancy test
Fertile patients must use effective contraception during and for at least 3 months after study therapy
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A. Socinski, MD | Florida Hospital Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18303435 | Result | Stinchcombe TE, Harper HD, Hensing TA, Moore DT, Crane JM, Atkins JN, Willard EM, Detterbeck FC, Socinski MA. The feasibility of adjuvant carboplatin and docetaxel in patients with curatively resected non-small cell lung cancer. J Thorac Oncol. 2008 Feb;3(2):145-51. doi: 10.1097/JTO.0b013e318160c5f1. |
| Label | URL |
|---|---|
| UNC Lineberger Comprehensive Cancer Center | View source |
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Of the 75 participants screened for eligibility, 72 went on to treatment and 3 participants withdrew consent prior to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Trial | adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25) docetaxel: 75 mg/m² intravenously, once, every 3 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Trial | adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25) docetaxel: 75 mg/m² intravenously, once, every 3 weeks |
| 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 | Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen | Feasibility was based on the percentage of patients completing four cycles of the carboplatin/docetaxel regimen to a high fraction of patients with curatively resected stage IIIIA non-small cell lung cancer within 12 weeks. | Patients assigned to treatment | Posted | Count of Participants | Participants | 12 weeks from initiating adjuvant therapy |
|
30 days following cessation of treatment
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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 | Single Arm Trial | adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25) docetaxel: 75 mg/m² intravenously, once, every 3 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac ischemia/infarction | Cardiac disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin V. Johnson | UNC Lineberger Comprehensive Cancer | 919-966-1125 | Robin_V_Johnson@med.unc.edu |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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|
| docetaxel | Drug | 75 mg/m² intravenously, once, every 3 weeks |
|
|
Safety determinations are based on the rate of drug-related adverse events (AEs) reported based upon the toxicity as measured by the NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). |
| Day 1 of treatment to 30 days after treatment discontinuation |
| Progression Free Survival | Relapse-free survival rate at 18 months. Patients were determined to have progression either by radiographic and/or pathological assessment by local physician per local standard of care monitoring for disease recurrence. | The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months |
| Overall Survival | Overall survival rate at 18 months. | The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months |
| Intercurrent Illness |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance status | A scale from 0-5 to describe a patient's level of functioning in terms of selfcare ability and activity level. 0, Fully active 1, Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours 3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 5. Dead | Count of Participants | Participants |
|
| Stage | Anatomic stage for NSCLC is the American Joint Committee on Cancer (AJCC) tumor node metastatic (TNM) system, which is based on: Size of primary tumor (T) and whether it has grown into nearby areas. Spread to regional lymph nodes (N). Spread (metastasis; M) to other organs of the body. Once the T, N, and M categories have been determined, this information is combined into a prognostic group. Higher numbers mean the cancer is more advanced. | Count of Participants | Participants |
|
| Histology | Count of Participants | Participants |
|
| Type of surgery | Type of pre-screening surgical resection undergone by subjects | Count of Participants | Participants |
|
|
|
| Secondary | Patterns of Recurrence in Patients Treated With This Regimen | Patterns were assessed with a staging chest computerized tomography (CT), bone or positron emission tomography (PET) scan and brain magnetic resonance imaging (MRI)/CT scan at recurrence. | Posted | Count of Participants | Participants | Up to 5 years |
|
|
|
| Secondary | Toxicity in Patients Treated With This Regimen | Safety determinations are based on the rate of drug-related adverse events (AEs) reported based upon the toxicity as measured by the NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). | Patients receiving treatment | Posted | Number | percentage of participants | Day 1 of treatment to 30 days after treatment discontinuation |
|
|
|
| Secondary | Progression Free Survival | Relapse-free survival rate at 18 months. Patients were determined to have progression either by radiographic and/or pathological assessment by local physician per local standard of care monitoring for disease recurrence. | Participants receiving treatment | Posted | Number | percentage of participants | The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months |
|
|
|
| Secondary | Overall Survival | Overall survival rate at 18 months. | Participants receiving treatment | Posted | Number | percentage of participants | The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months |
|
|
|
| 19 |
| 72 |
| 63 |
| 72 |
| Hypotension | Vascular disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Supraventricular and nodal arrhythmia - Atrial fibrillation | Cardiac disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Supraventricular and nodal arrhythmia - Supraventricular arrhythmia not otherwise specified (NOS) | Cardiac disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | NCI CTCAE Version 3 | Non-systematic Assessment | Fever of unknown origin without clinically or microbiologically documented infection)(ANC <1.0 x 10e9/L, fever >=38.5 degrees C) |
|
| Infections, Other (Specify, _Neutropenic sepsis) | Infections and infestations | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Syncope (fainting) | Nervous system disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) | Investigations | NCI CTCAE Version 3 | Non-systematic Assessment | Neutropenia/febrile neutropenia |
|
| Leukocytes (total WBC) | Investigations | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Leukocytes (total WBC) | Investigations | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) | Investigations | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Platelets | Investigations | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Supraventricular and nodal arrhythmia - Supraventricular arrhythmia NOS | Cardiac disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Cardiac ischemia/infarction | Cardiac disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Constitutional Symptoms - Other (Specify- Weakness) | General disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Heartburn/dyspepsia | Gastrointestinal disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Mucositis/stomatitis (functional/symptomatic) - Oral cavity | Gastrointestinal disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Taste alteration (dysgeusia) | Nervous system disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Ulcer, GI - Stomach | Gastrointestinal disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Edema: limb | General disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Mood alteration - Anxiety | Psychiatric disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Neuropathy: motor | Nervous system disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Neuropathy: sensory | Nervous system disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Syncope (fainting) | Nervous system disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Dry eye syndrome | Eye disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Pain - Back | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Pain - bone | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Pain -Chest | General disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Pain - Joint | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Pain - Muscle | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Pain - Other (Specify, _Thoracotomy site) | General disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Hiccoughs (hiccups, singultus) | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Pulmonary/Upper Respiratory - Other (Specify, _paranasal sinus reaction; runny nose/chills) | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Renal/Genitourinary - Other (Specify, __UTI) | Renal and urinary disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 3 | Non-systematic Assessment |
|
Not provided
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| distant relapse within the brain |
|
| Title | Measurements |
|---|---|
|
| Febrile Neutorpenia |
|
| Nausea |
|
| Vomiting |
|
| Diarrhea |
|
| Infusional reactions |
|
| Dehydration |
|
| Fatigue/asthenia |
|
| Syncope |
|
| Arrythmia |
|
| Proteinuria |
|
| Infection |
|
| Dyspnea |
|