Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 106296 | Other Identifier | USF IRB | |
| CA225286 | Other Identifier | Bristol-Myers Squibb |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This research is being done to find out if a treatment consisting of a combination of thoracic radiotherapy with cetuximab, given together, and followed by chemotherapy with docetaxel and cetuximab (also given together) will kill the cancer cells in the patient's body and shrink the size of their tumor without causing unacceptable side effects. This may allow patients to live longer or decrease the frequency and/or severity of the symptoms caused by the cancer without increasing the frequency and/or severity of the symptoms caused by the treatment.
Patients will be asked to spend about six months in this study. There will be 4 different phases in this study as follows: (1) Loading Phase: This is the first week (week 1) of the study, when patients receive their first (loading) dose of cetuximab only, in the vein. (2) Concurrent Phase: During this phase patients will be treated simultaneously (concurrently) with radiation therapy to their chest and cetuximab. Radiation is delivered 5 days a week, Monday to Friday for a total of 7 weeks (weeks 2-8). Cetuximab is delivered in the vein, weekly, during the weeks of radiation. (3) Recovery Phase: Patients receive no treatment during these next 3 weeks (weeks 9-11). This phase is designed to allow patients to recover from side effects before they start the last phase. (4) Consolidation Phase: The last phase. Patients will receive 3 doses of chemotherapy with docetaxel during this phase. Docetaxel is given intravenously every 21 days. Patients also receive weekly cetuximab during this phase. Cetuximab is delivered in a similar way as it was during the concurrent (second) phase of this study. In total, this phase lasts 6 weeks (weeks 12-18). Once the therapy treatment is completed, and if the patient's cancer did not get worse, follow up visits will include visits to their physician every three months for 2 years, then every 4 months for 2 years or more, as long as their cancer doesn't get worse (at which time they will be removed from the study).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetuximab Plus Radiotherapy | Experimental | Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT). Patients were treated with definitive radiotherapy (70 Gy in 35 fractions, per our currently-existing institutional standard) with concurrent cetuximab followed by 3 cycles of consolidation docetaxel plus cetuximab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression Free Survival (PFS) | Progression Free Survival is defined as the interval between the date of the first cetuximab administration and the date of objective progression of disease. Progression was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Median Overall Survival (OS) | Overall survival is defined as the time from randomization until death from any cause. | Up to 36 months |
| Overall Response Rate (ORR) | ORR = Complete Response (CR) + Partial Response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response: Disappearance of all target lesions; Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. |
Not provided
Inclusion Criteria:
Histologically or cytologically confirmed inoperable or unresectable, LA-NSCLC (adenocarcinoma, squamous cell carcinoma or anaplastic large cell carcinoma or non-small cell otherwise not specified).
Eligible Stages: Stages IIA through IIIA disease if it is felt that they are not candidates for possible resection, medically or otherwise. Stage IIIA (multi-station mediastinal lymph nodes) and stage IIIB disease without significant pleural effusion (metastases to contralateral mediastinal or supraclavicular lymph nodes) are also eligible.
Age ≥ 70 OR Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 2 at time of registration OR weight loss ≥ 5% in the preceding three months to the time of registration
Must have measurable disease by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. When applicable, baseline measurements/evaluations must be obtained within 4 weeks prior to registration.
Must have adequate bone marrow reserve as determined by the following laboratory values, obtained within 14 days prior to registration:
Adequate renal and liver function as determined by the following laboratory values, obtained within 14 days prior to registration:
Written, informed consent must be obtained prior to registration
Women of childbearing potential (WOCBP) must use an accepted, effective method of contraception during the course of the study, in a manner such that risk of failure is minimized. Sexually active males enrolled should understand the risks to any sexual partner of childbearing potential; must also practice an effective method of contraception. WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy; have a negative pregnancy test within 7 days prior to first receiving investigational product; be instructed to contact the Investigator immediately if they suspect they might be pregnant at any time during study participation. Investigator must immediately notify Bristol-Myers Squibb (BMS) in the event of a confirmed pregnancy in a patient participating in the study. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alberto Chiappori, M.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 |
Not provided
Participants were recruited at Moffitt Cancer Center from May, 2008 to November, 2010.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cetuximab Plus Radiotherapy | Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Conformal Thoracic Radiotherapy (CTRT) | Radiation |
|
|
|
| Up to 36 months |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cetuximab Plus Radiotherapy | Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | 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 | Median Progression Free Survival (PFS) | Progression Free Survival is defined as the interval between the date of the first cetuximab administration and the date of objective progression of disease. Progression was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | All participants | Posted | Median | 95% Confidence Interval | months | Up to 36 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Median Overall Survival (OS) | Overall survival is defined as the time from randomization until death from any cause. | All participants | Posted | Median | 95% Confidence Interval | months | Up to 36 months |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | ORR = Complete Response (CR) + Partial Response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response: Disappearance of all target lesions; Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. | All participants | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 36 months |
|
|
3 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cetuximab Plus Radiotherapy | Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT) | 20 | 27 | 27 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTC V3 | Systematic Assessment |
| |
| Low Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia - Atrial fibrillation | Cardiac disorders | CTC V3 | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTC V3 | Systematic Assessment |
| |
| Sweating (diaphoresis) | General disorders | CTC V3 | Systematic Assessment |
| |
| Death not associated with CTCAE term - Death | General disorders | CTC V3 | Systematic Assessment |
| |
| Death not associated with CTCAE term - Sudden death | General disorders | CTC V3 | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Mucositis/stomatitis (functional/symptomatic) - Oral cavity | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Stricture/stenosis (including anastomotic), GI - Esophagus | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTC V3 | Systematic Assessment |
| |
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung | Infections and infestations | CTC V3 | Systematic Assessment |
| |
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Urinary Tract | Infections and infestations | CTC V3 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Esophagus | Infections and infestations | CTC V3 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia) | Infections and infestations | CTC V3 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis) | Infections and infestations | CTC V3 | Systematic Assessment |
| |
| Edema: limb | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized | Musculoskeletal and connective tissue disorders | CTC V3 | Systematic Assessment |
| |
| Musculoskeletal/Soft Tissue - Other | Musculoskeletal and connective tissue disorders | CTC V3 | Systematic Assessment |
| |
| Mood alteration - Agitation | General disorders | CTC V3 | Systematic Assessment |
| |
| Pain - Abdomen NOS | General disorders | CTC V3 | Systematic Assessment |
| |
| Pain - Throat/pharynx/larynx | General disorders | CTC V3 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Hiccoughs (hiccups, singultus) | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders | CTC V3 | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTC V3 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Stricture/stenosis (including anastomotic), GI - Esophagus | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Taste alteration (dysgeusia) | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Heartburn/dyspepsia | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Mucositis/stomatitis clinical exam) - Oral cavity | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTC V3 | Systematic Assessment |
| |
| Weight loss | General disorders | CTC V3 | Systematic Assessment |
| |
| Constitutional Symptoms - Other | General disorders | CTC V3 | Systematic Assessment |
| |
| Insomnia | General disorders | CTC V3 | Systematic Assessment |
| |
| Fever (in the absence of neutropenia) | Infections and infestations | CTC V3 | Systematic Assessment |
| |
| Sweating (diaphoresis) | General disorders | CTC V3 | Systematic Assessment |
| |
| Rash: dermatitis associated with radiation - Radiation | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Hiccoughs | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Pain - Head/headache | General disorders | CTC V3 | Systematic Assessment |
| |
| Pain - Back | General disorders | CTC V3 | Systematic Assessment |
| |
| Pain - Chest/thorax NOS | General disorders | CTC V3 | Systematic Assessment |
| |
| Pain - Throat/pharynx/larynx | General disorders | CTC V3 | Systematic Assessment |
| |
| Pain - Abdomen NOS | General disorders | CTC V3 | Systematic Assessment |
| |
| Pain - Esophagus | General disorders | CTC V3 | Systematic Assessment |
| |
| Pain - Other | General disorders | CTC V3 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia) | Infections and infestations | CTC V3 | Systematic Assessment |
| |
| Febrile neutropenia (fever of unknown origin) | Infections and infestations | CTC V3 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Bronchus | Infections and infestations | CTC V3 | Systematic Assessment |
| |
| Infection with unknown ANC - Oral cavity-gums (gingivitis) | Infections and infestations | CTC V3 | Systematic Assessment |
| |
| Dizziness | General disorders | CTC V3 | Systematic Assessment |
| |
| Confusion | General disorders | CTC V3 | Systematic Assessment |
| |
| Musculoskeletal/Soft Tissue - Other | Musculoskeletal and connective tissue disorders | CTC V3 | Systematic Assessment |
| |
| Muscle weakness generalized or specific area (not due to neuropathy) whole body/generalized | Musculoskeletal and connective tissue disorders | CTC V3 | Systematic Assessment |
| |
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Edema: limb | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Edema: head and neck | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTC V3 | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTC V3 | Systematic Assessment |
| |
| Ocular/Visual - Other | Eye disorders | CTC V3 | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTC V3 | Systematic Assessment |
| |
| Low Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
|
Accrual, and therefore treatment ended earlier than planned due to pulmonary toxicity. Three participants remain on follow-up.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alberto Chiappori, M.D. | H. Lee Moffitt Cancer Center and Research Institute | 813-745-3050 | alberto.chiappori@moffitt.org |
| 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 |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D000077143 | Docetaxel |
| D007167 | Immunotherapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
|
|