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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02587 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| NCI-1990 | |||
| CASE-1503 | |||
| CDR0000365315 | |||
| CASE-CWRU-1503 | Other Identifier | Case Comprehensive Cancer Center | |
| 1990 | Other Identifier | CTEP | |
| U01CA062502 | U.S. NIH Grant/Contract | View source | |
| P30CA043703 | U.S. NIH Grant/Contract | View source |
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Drugs used in chemotherapy, such as rebeccamycin analog, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well rebeccamycin analog works as second-line therapy in treating patients with limited-stage or extensive-stage small cell lung cancer that has relapsed after previous first-line chemotherapy.
OBJECTIVES:
I. Determine the objective response rate in patients with limited or extensive stage small cell lung cancer that relapsed after prior first-line chemotherapy when treated with rebeccamycin analogue as second-line therapy.
II. Determine the duration of remission and survival of patients treated with this drug.
III. Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed annually.
PROJECTED ACCRUAL: A total of 20-39 patients will be accrued for this study within 15 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (becatecarin) | Experimental | Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| becatecarin | Drug | Given IV |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate Estimated as the Proportion of Responders | Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. An exact binomial 95% confidence interval will be calculated for this proportion. | Up to 4 years |
| Progression Free Survival | Median time of patients without Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Duration of remission will be analyzed using Kaplan-Meier curves. | Up to 4 years |
| Overall Survival | Median time of patient survival. Duration of survival will be analyzed using Kaplan-Meier curves. | Up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Percentage of patients that are progression free at 6 months. | 6 months |
| Overall Survival | Percentage of patients alive at 1 year |
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Inclusion Criteria:
Diagnosis of small cell lung cancer (SCLC)
At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
Sensitive* relapsed disease after only 1 prior chemotherapy regimen
Brain metastasis allowed provided the following criteria are met:
Performance status - ECOG 0-2
Performance status - Karnofsky 60-100%
At least 12 weeks
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9.0 g/dL
AST and ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver involvement is present)
Bilirubin ≤ 1.5 mg/dL
Creatinine < 2.0 mg/dL
Creatinine clearance ≥ 60 mL/min
No New York Heart Association class III or IV heart disease
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active or ongoing infection
No other concurrent uncontrolled illness
No psychiatric illness or social situation that would preclude study compliance
See Disease Characteristics
See Disease Characteristics
See Disease Characteristics
Prior radiotherapy allowed
No other concurrent investigational agents
No other concurrent therapies for SCLC
No concurrent combination antiretroviral therapy for HIV-positive patients
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| Name | Affiliation | Role |
|---|---|---|
| Afshin Dowlati | Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
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Patients were recruited for Cleveland area medical hospitals between November 2004 and November 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Rebeccamycin Analogue) | Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. becatecarin : Given IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 1 year |
| COMPLETED |
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| NOT COMPLETED |
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One patient died prior to start of treatment and is not included on any data analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Rebeccamycin Analogue) | Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. becatecarin : Given IV |
| 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, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| ECOG Performance Status | Based on a scale of 0-4 with 0=100 Asymptomatic; 1=80-90 Symptomatic, fully ambulatory; 2=60-70 Symptomatic, in bed less than 50% of the day; 3=40-50 Symptomatic, in bed more than 50% of the day, but not bedridden; 4=20-30 Bedridden | Number | participants |
| ||||||||||||||||||||||
| Prior Therapy | Number of patients exceeds number on study as some patients had both chemo and radiation. | 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 | Objective Response Rate Estimated as the Proportion of Responders | Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. An exact binomial 95% confidence interval will be calculated for this proportion. | Intent to treat | Posted | Number | participants | Up to 4 years |
|
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| Primary | Progression Free Survival | Median time of patients without Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Duration of remission will be analyzed using Kaplan-Meier curves. | Intent to treat | Posted | Median | 95% Confidence Interval | months | Up to 4 years |
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| Primary | Overall Survival | Median time of patient survival. Duration of survival will be analyzed using Kaplan-Meier curves. | Intent to treat | Posted | Median | 95% Confidence Interval | months | Up to 4 years |
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| Secondary | Progression Free Survival | Percentage of patients that are progression free at 6 months. | Intent to treat | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
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| Secondary | Overall Survival | Percentage of patients alive at 1 year | Intent to treat | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
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Adverse events were collected while patients were on study, up to four 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 | Treatment (Rebeccamycin Analogue) | Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. becatecarin : Given IV | 7 | 20 | 19 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac troponin T (cTnT) | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cardiac-ischemia/infarction | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Death not associated with CTCAE term - Multi-organ failure | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea patients without colostomy | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with grade 3 or 4 neutropenia (ANC <1.0 x 10e9/L) | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Lung Infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Obstruction/stenosis of airway: Bronchus | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Supraventricular arrhythmias (SVT/atrial fibrillation/flutter) | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain or cramping | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ataxia (incoordination) | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Chest Congestion/Flu like symptoms | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Chest Pressure | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Cognitive disturbance/learning problems | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Confusion | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Diarrhea patients without colostomy | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Dizziness/lightheadedness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Dyspepsia/heartburn | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Edema | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Extrapyramidal/involuntary movement/restlessness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Fatigue (lethargy, malaise, asthenia) | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Insomnia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Intermittent Halatosis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Mood alteration-anxiety, agitation | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Mood alteration-depression | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Mouth dryness | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Neuropathy-sensory | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Pain NOS | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Rigors, chills | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Taste disturbance (dysgeusia) | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight loss | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Afshin Dowlati MD | Case Comprehensive Cancer Center | 216-844-1228 | afshin.dowlati@uhhospitals.org |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C093269 | becatecarin |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 2 |
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