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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA068485 | U.S. NIH Grant/Contract | View source | |
| VU-VICC-THO-0920 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well bendamustine works as second- or third-line therapy in treating patients with relapsed or refractory small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive bendamustine IV over 1 hour on days 1 and 2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6-8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bendamustine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bendamustine hydrochloride | Drug | Bendamustine 120 mg/m2 IV on days 1 and 2 of a 21-day treatment cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression | Estimated probable duration from on-study date to date of disease progression, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions. | On-study to date of progression, measured following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (during 126 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Each Worst-grade Toxicity | Number of patients with worst-grade toxicity at each of five grades following NCI Common Toxicity Criteria with grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening/disabling, 5 = death. | Day 1 of each 21-day cycle for 6 cycles and at 30 days after end of treatment, at 156 days |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer
Relapsed or refractory disease after 1-2 prior chemotherapy regimens
Measurable disease
ECOG - Eastern Cooperative Oncology Group performance status 0-2
ANC ≥ 1,500/mm³: ANC = Absolute neutrophil count
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9 g/dL
Bilirubin normal
AST/ALT ≤ 2 times upper limit of normal (ULN) (≤ 5 times ULN in patients with hepatic metastases; AST/ALT = alanine transaminase (ALT) and aspartate aminotransferase (AST)
Creatinine clearance > 40 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception before, during, and for ≥ 3 months after completion of study therapy
No known hypersensitivity to bendamustine
No other malignancy for which the patient has been treated within the past year except for nonmelanoma skin cancer or carcinoma in situ of the cervix
No cardiac disease, including any of the following:
No uncontrolled infection
No other concurrent chemotherapy, immunotherapy, or anti-tumor hormonal therapy
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| Name | Affiliation | Role |
|---|---|---|
| Leora Horn, M.D. | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hardin Memorial Hosptial | Elizabethtown | Kentucky | 42701 | United States | ||
| The Jones Clinic - Germantown |
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| Label | URL |
|---|---|
| Vanderbilt-Ingram Cancer Center, Find a Clinical Trial | View source |
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59 patients consented, 9 were determined to be ineligible to participate
This study opened to accrual in September 2009 and closed to accrual in February 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Bendamustine | Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Best Response | Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD. | On-treatment date to date of disease progression, following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days) |
| Progression-free Survival | Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions. | On-study date to lesser of date of progression or date of death from any cause ,measured following cycle 2, 4, 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days) |
| Overall Survival | Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details) | On study to date of death from any cause or last date known alive, measured every 6-8 weeks from the end of treatment, up to 31 months |
| Germantown |
| Tennessee |
| 38138 |
| United States |
| Jackson-Madison County Hospital | Jackson | Tennessee | 38301 | United States |
| Baptist Regional Cancer Center at Baptist Riverside | Knoxville | Tennessee | 37901 | United States |
| Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville | Tennessee | 37064 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Patients with Relapsed or Refractory Small Cell Lung Cancer (SCLC)who received study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Bendamustine | Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Time to Progression | Estimated probable duration from on-study date to date of disease progression, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions. | All patients are included in the analysis on intention-to treat basis. Analysis is by Kaplan-Meier method, where progression is an event, with censoring for non-progressed patients at greater of off-study date, last known alive date, or date of death not attributable to disease progression. | Posted | Median | 95% Confidence Interval | days | On-study to date of progression, measured following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (during 126 days) |
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| |||||||||||||||||||||||||
| Secondary | Number of Patients With Each Worst-grade Toxicity | Number of patients with worst-grade toxicity at each of five grades following NCI Common Toxicity Criteria with grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening/disabling, 5 = death. | Total number of patients reported with any toxicity | Posted | Number | participants | Day 1 of each 21-day cycle for 6 cycles and at 30 days after end of treatment, at 156 days |
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| |||||||||||||||||||||||||||
| Secondary | Best Response | Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD. | All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is non-evaluable for best overall response. 8 patients were not evaluable. | Posted | Number | participants | On-treatment date to date of disease progression, following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days) |
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| Secondary | Progression-free Survival | Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions. | All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known alive date. | Posted | Median | 95% Confidence Interval | days | On-study date to lesser of date of progression or date of death from any cause ,measured following cycle 2, 4, 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival | Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details) | All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where death is an event, with censoring for non-expired patients at greater of off-study date or last known alive date. | Posted | Median | 95% Confidence Interval | days | On study to date of death from any cause or last date known alive, measured every 6-8 weeks from the end of treatment, up to 31 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 | Bendamustine | Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles | 27 | 50 | 50 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| atrial fibrillation | Cardiac disorders |
| |||
| troponin levels postive | Cardiac disorders |
| |||
| clot, left upper arm | Vascular disorders |
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| chills | General disorders |
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| creatine | Investigations |
| |||
| death not associated with CTCAE term-NOS | General disorders |
| |||
| death not associated with CTCAE term-disease progression | General disorders |
| |||
| diarrhea | Gastrointestinal disorders |
| |||
| dyspnea | Respiratory, thoracic and mediastinal disorders |
| |||
| fatigue | General disorders |
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| fever in the absence of neutropenia, where neutropenia is defined as ANC < 1.0 x 10e9/L | General disorders |
| |||
| hip fracture | Musculoskeletal and connective tissue disorders |
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| glucose, serum-low | Metabolism and nutrition disorders |
| |||
| hemoglobin | Blood and lymphatic system disorders |
| |||
| hypoxia | Respiratory, thoracic and mediastinal disorders |
| |||
| infection-other | Infections and infestations |
| |||
| infection-documented with Grade 3 or 4 neutrophils-pneumonia | Respiratory, thoracic and mediastinal disorders |
| |||
| infection with normal ANC or Grade 1 or 2 neutrophils-bronchus | Respiratory, thoracic and mediastinal disorders |
| |||
| infection with normal ANC or Grade 1 or 2 neutrophils-lung | Respiratory, thoracic and mediastinal disorders |
| |||
| infection with unknown ANC-lung | Respiratory, thoracic and mediastinal disorders |
| |||
| nausea | Gastrointestinal disorders |
| |||
| neutrophils/granulocytes | Blood and lymphatic system disorders |
| |||
| pain-abdomen NOS | Gastrointestinal disorders |
| |||
| chest pain | Cardiac disorders |
| |||
| pain-right hip | Musculoskeletal and connective tissue disorders |
| |||
| pain NOS | General disorders |
| |||
| pericardial effusion-non-malignant | Cardiac disorders |
| |||
| pleural effusion | Respiratory, thoracic and mediastinal disorders |
| |||
| pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders |
| |||
| potassium, serum-low | Metabolism and nutrition disorders |
| |||
| acute respiratory distress | Respiratory, thoracic and mediastinal disorders |
| |||
| bilateral basilar pneumonia | Respiratory, thoracic and mediastinal disorders |
| |||
| pulomonary emboli-multiple | Respiratory, thoracic and mediastinal disorders |
| |||
| right lower lobe lung collapse | Respiratory, thoracic and mediastinal disorders |
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| acute renal failure | Renal and urinary disorders |
| |||
| hyponatremia | Metabolism and nutrition disorders |
| |||
| somnolence | Nervous system disorders |
| |||
| superior vena cava syndrome | Vascular disorders |
| |||
| thrombocytopenia | Blood and lymphatic system disorders |
| |||
| vomiting | Gastrointestinal disorders |
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| hemoptysis | Respiratory, thoracic and mediastinal disorders |
| |||
| pneumonia | Respiratory, thoracic and mediastinal disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| albumin, serum-low | Metabolism and nutrition disorders |
| |||
| alkaline phosphatase | Investigations |
| |||
| Alanine aminotransferase, serum glutamic pyruvic transaminase (ALT, SGPT) | Investigations |
| |||
| anorexia | Metabolism and nutrition disorders |
| |||
| aspartate transaminase, serum glutamic oxaloacetic transaminase (AST, SGOT) | Investigations |
| |||
| constipation | Gastrointestinal disorders |
| |||
| constitutional symptoms-other | General disorders |
| |||
| cough | Respiratory, thoracic and mediastinal disorders |
| |||
| dermatology/skin-other | Skin and subcutaneous tissue disorders |
| |||
| diarrhea | Gastrointestinal disorders |
| |||
| dizziness | Nervous system disorders |
| |||
| dyspnea | Respiratory, thoracic and mediastinal disorders |
| |||
| edema-limb | General disorders |
| |||
| fatigue | General disorders |
| |||
| calcium, serum-low | Metabolism and nutrition disorders |
| |||
| gastrointestinal-other | Gastrointestinal disorders |
| |||
| glucose, serum-high | Metabolism and nutrition disorders |
| |||
| hemoglobin | Blood and lymphatic system disorders |
| |||
| hypotension | Vascular disorders |
| |||
| insomnia | Psychiatric disorders |
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| leukocytes | Blood and lymphatic system disorders |
| |||
| magnesium, serum-low | Metabolism and nutrition disorders |
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| metabolic, laboratory-other | Metabolism and nutrition disorders |
| |||
| depression | Psychiatric disorders |
| |||
| mucositis (functional/symptomatic)-oral cavity | Gastrointestinal disorders |
| |||
| nausea | Gastrointestinal disorders |
| |||
| neurology-other | Nervous system disorders |
| |||
| neuropathy-sensory | Nervous system disorders |
| |||
| neutrophils/granulocytes | Blood and lymphatic system disorders |
| |||
| pain-abdomen NOS | Gastrointestinal disorders |
| |||
| pain-back | Musculoskeletal and connective tissue disorders |
| |||
| pain-extremity, limb | Musculoskeletal and connective tissue disorders |
| |||
| pain-joint | Musculoskeletal and connective tissue disorders |
| |||
| platelets | Blood and lymphatic system disorders |
| |||
| potassium, serum-low | Metabolism and nutrition disorders |
| |||
| pulmonary/upper respiratory-other | Respiratory, thoracic and mediastinal disorders |
| |||
| sodium, serum-low | Investigations |
| |||
| vomiting | Gastrointestinal disorders |
| |||
| weight loss | Investigations |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leora Horn, MD | Vanderbilt-Ingram Cancer Center | 615-936-2033 | leora.horn@vanderbilt.edu |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| 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 |
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| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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