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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CASE4507 | Other Identifier | Case Comprehensive Cancer Center | |
| CASE 4507-CC694 | Other Identifier | Cancer Center IRB | |
| NCI-2010-00547 | Other Identifier | NCI/CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with docetaxel and gemcitabine hydrochloride may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel and gemcitabine hydrochloride works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes and docetaxel IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease may then continue to receive bevacizumab alone for up to 12 months in the absence of disease progression.
After completion of study treatment, patients are followed up every 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab, Docetaxel, and Gemcitabine | Experimental | Treatment repeats every 21 days for up to 6 courses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Biological | 15 mg/kg on day 1 of a 21-day cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival(PFS) | PFS is defined as time to death or first occurrence of documented disease progression assessed by the investigator as per the RECIST guidelines (at lease a 20% increase in the diameter of a lesion, in addition to an absolute increase of 5mm). If no deaths occur prior to progression, this measure will be the same as the median time to progression. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Median Time to Progression | Time to progression (TTP) is defined as the time from start of treatment to first evidence of disease progression, defined per the RECIST 1.1 criteria as at least a 20% increase in the diameter of a lesion and an absolute increase of at least 5mm. | 1 year |
| Best Response |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed non-squamous cell non-small cell lung cancer
Bidimensionally measurable disease
No known CNS disease, except for previously treated brain metastasis defined as no evidence of progression or hemorrhage after treatment AND no ongoing requirement for dexamethasone as documented by clinical examination, MRI, or CT scan
No known metastatic disease to the gastrointestinal tract (e.g., stomach, small bowel, or large bowel)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Nathan Pennell, MD, PhD | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Principal Investigator |
| Afshin Dowlati, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30602615 | Derived | Patil PD, Shapiro M, Hashemi Sadraei N, Pennell NA. An Open-Label Phase II Trial of Bevacizumab plus Docetaxel and Gemcitabine in Advanced, Previously Untreated Nonsquamous Non-Small Cell Lung Cancer. Oncologist. 2019 Apr;24(4):457-e126. doi: 10.1634/theoncologist.2018-0857. Epub 2019 Jan 2. |
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Patients were recruited from local medical clinics from 12/2009 to 4/2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab, Docetaxel, and Gemcitabine | Treatment repeats every 21 days for up to 6 courses. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| docetaxel |
| Drug |
75 mg/m2 on day 1 |
|
| gemcitabine hydrochloride | Drug | 900 mg/m2 on days 1, and 8, |
|
The number of patients with a response will be assessed using the RECIST criteria of complete response (the disappearance of all target lesions); partial response (at least a 30% decrease in the diameter of lesions); progressive disease at least a 20% increase in the diameter of lesions); or stable disease(neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease) |
| 1 year |
| Fairview Hospital, Moll Pavilion | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
| Hillcrest Hospital, a Cleveland Clinic Hospital | Mayfield Heights | Ohio | 44124 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab, Docetaxel, and Gemcitabine | Treatment repeats every 21 days for up to 6 courses. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | 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 | Progression Free Survival(PFS) | PFS is defined as time to death or first occurrence of documented disease progression assessed by the investigator as per the RECIST guidelines (at lease a 20% increase in the diameter of a lesion, in addition to an absolute increase of 5mm). If no deaths occur prior to progression, this measure will be the same as the median time to progression. | Intent to treat | Posted | Median | 95% Confidence Interval | months | 1 year |
|
|
| |||||||||||||||||||||||||
| Secondary | Median Time to Progression | Time to progression (TTP) is defined as the time from start of treatment to first evidence of disease progression, defined per the RECIST 1.1 criteria as at least a 20% increase in the diameter of a lesion and an absolute increase of at least 5mm. | Intent to treat | Posted | Median | 95% Confidence Interval | months | 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Best Response | The number of patients with a response will be assessed using the RECIST criteria of complete response (the disappearance of all target lesions); partial response (at least a 30% decrease in the diameter of lesions); progressive disease at least a 20% increase in the diameter of lesions); or stable disease(neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease) | One patient was unevaluable for response due to missing baseline tumor measurement. | Posted | Number | participants | 1 year |
|
|
Patients are followed for adverse events while on study for up to 2 years.
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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 | Bevacizumab, Docetaxel, and Gemcitabine | Treatment repeats every 21 days for up to 6 courses. | 10 | 13 | 13 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lung Infection | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Depressed Level of Consciousness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction/hypersensitivity | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment | including drug fever |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemoglobinemia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leukocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Superaventricular and nodal arrhythmia-Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Supraventricular and nodal arrythmia-Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment | asthenia, lethargy, malaise |
|
| Fever | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Insomnia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sweating | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight gain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight loss | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bruising | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment | In absence of Grade 3 or 4 thrombocytopenia |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rash- acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ulceration | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Night Sweats, intermittent | Endocrine disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mucositis/stomatitis-oral | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mucositis/stomatitis-rectum | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dysgeusia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, GI | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage-pulmonary/upper respiratory | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage/Bleeding | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection-Lung | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection-Bladder | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection-Conjuctiva | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection-Mucosa | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection-Upper aerodigestive NOS | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Opportunistic infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment | associated with >= Grade 2 Lymphopenia |
|
| Edema-limb | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymphocele | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| ALT, SGPT | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| AST, SGOT | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Glycosuria | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Proteinuria | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fracture | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Confusion | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Extrapyramidal/involuntary movement/restlessness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mood alterations | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment | Anxiety/depression |
|
| Neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Epiphora | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain- Abdomen NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain- Chest/thorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain- dental/teeth/peridontal | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain- eye | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain- Head/headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain- Muscular/skeletal | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain-other | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain- Throat/pharynx/larynx | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment | non-malignant |
|
| Pneumonititis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bronchospasm, wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Voice changes/dysarthria | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sexual/reproductive function | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nathan Pennell MD | Case Comprehensive Cancer Center | 216-445-9285 | penneln@ccf.org |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| D002282 | Adenocarcinoma, Bronchiolo-Alveolar |
| 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 |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077143 | Docetaxel |
| D000093542 | Gemcitabine |
| 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 |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|