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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Pharmacia and Upjohn | INDUSTRY |
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In this multicenter trial, we plan to evaluate the feasibility and toxicity of initial treatment with irinotecan/carboplatin/radiation therapy, followed by treatment with bevacizumab, in patients with limited stage small cell lung cancer.
Upon determination of eligibility, all patients will be receive:
Patients will receive 4 courses of irinotecan/carboplatin. Radiation therapy will begin concurrently with the third course of chemotherapy. The intervals between chemotherapy courses will be 21 days except for the interval between the third and fourth courses (during radiation therapy), which will be 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan | Drug | 50mg/m2 days 1 & 8 each 21-day cycle 1 & 2, 28-day cycle 3 & 4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC) | Toxicity was evaluated in all patients who received at least 1 dose of therapy, and graded according to CTCAE v. 3. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 2-Year Progression-free Survival (PFS) | Progression-free survival (PFS) was defined as the date of study entry until the date of tumor progression or death. 2-Year PFS is the percentage of patients alive and without progressive disease (PD) 2 years from the date of study entry. | 24 months |
| Overall Response Rate |
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Inclusion Criteria:
To be included in this study, you must meet the following criteria:
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
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| Name | Affiliation | Role |
|---|---|---|
| John D. Hainsworth, MD | SCRI Development Innovations, LLC | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19875975 | Background | Spigel DR, Greco FA, Zubkus JD, Murphy PB, Saez RA, Farley C, Yardley DA, Burris HA 3rd, Hainsworth JD. Phase II trial of irinotecan, carboplatin, and bevacizumab in the treatment of patients with extensive-stage small-cell lung cancer. J Thorac Oncol. 2009 Dec;4(12):1555-60. doi: 10.1097/JTO.0b013e3181bbc540. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10). |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 2-Year Progression-free Survival (PFS) | Progression-free survival (PFS) was defined as the date of study entry until the date of tumor progression or death. 2-Year PFS is the percentage of patients alive and without progressive disease (PD) 2 years from the date of study entry. | All patients were assessed for progression free survival. | Posted | Number | percentage of participants | 24 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 | Intervention | Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary/Upper Respiratory - Other (Acute respiratory failure) | Respiratory, thoracic and mediastinal disorders | CTCAE v. 3 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE v. 3 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Hainsworth, MD | Sarah Cannon Research Institute | 1-877-691-7274 | ASKSARAH@scresearch.net |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| D016190 | Carboplatin |
| D000068258 | Bevacizumab |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
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| Carboplatin | Drug | AUC 5 |
|
|
| Bevacizumab | Drug | 10mg/kg IV every 2 weeks for 10 doses starting week 16 |
|
|
| Radiation | Radiation |
|
Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. |
| 18 month |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Overall Response Rate | Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. | All patients were evaluated for response by RECIST v. 1 criteria. All patients with major responses had confirmation of response on repeat scans by the same technique(s) 4 weeks (or longer) later. | Posted | Number | 95% Confidence Interval | percentage of participants | 18 month |
|
|
|
| Primary | Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC) | Toxicity was evaluated in all patients who received at least 1 dose of therapy, and graded according to CTCAE v. 3. | Patients who received at least one dose of bevacizumab maintenance therapy were assessed for toxicities. | Posted | Number | Grade 3/4 Toxicity Events | 18 months |
|
|
|
| 35 |
| 60 |
| 60 |
| 60 |
| Hemorrhage, GI (Upper GI NOS) | Blood and lymphatic system disorders | CTCAE v. 3 | Systematic Assessment |
|
| Infection - Other (Aspergillus pneumonia) | Infections and infestations | CTCAE v. 3 | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE v. 3 | Systematic Assessment |
|
| Death not associated with CTCAE term (Disease Progression NOS) | General disorders | CTCAE v. 3 | Systematic Assessment |
|
| Fistula, GI - esophagus | Gastrointestinal disorders | CTCAE v. 3 | Systematic Assessment |
|
| Liver dysfunction/failure (clinical) | Hepatobiliary disorders | CTCAE v. 3 | Systematic Assessment |
|
| Infection - Other (influenza) | Infections and infestations | CTCAE v. 3 | Systematic Assessment |
|
| Infection with Grade 3/4 Neutrophils - Blood | Infections and infestations | CTCAE v. 3 | Systematic Assessment |
|
| Infection - Other (obstructive pneumonia) | Infections and infestations | CTCAE v. 3 | Systematic Assessment |
|
| Perforation, GI - Colon | Gastrointestinal disorders | CTCAE v. 3 | Systematic Assessment |
|
| Infection with unknown ANC - Lung (pnemonia) | Respiratory, thoracic and mediastinal disorders | CTCAE v. 3 | Systematic Assessment |
|
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE v. 3 | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE v. 3 | Systematic Assessment |
|
| Pulmonary fibrosis (radiographic changes) | Respiratory, thoracic and mediastinal disorders | CTCAE v. 3 | Systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE v. 3 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE v. 3 | Systematic Assessment |
|
| Neutrophils | Blood and lymphatic system disorders | CTCAE v. 3 | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE v. 3 | Systematic Assessment |
|
| Mood Alteration - Anxiety | Psychiatric disorders | CTCAE v. 3 | Systematic Assessment |
|
| Pain - joint | General disorders | CTCAE v. 3 | Systematic Assessment |
|
| Pain - back | General disorders | CTCAE v. 3 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE v. 3 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v. 3 | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE v. 3 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE v. 3 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE v. 3 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE v. 3 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE v. 3 | Systematic Assessment |
|
| Edema | General disorders | CTCAE v. 3 | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE v. 3 | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE v. 3 | Systematic Assessment |
|
| Hemorrhage, Pulmonary/upper respiratory | Blood and lymphatic system disorders | CTCAE v. 3 | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE v. 3 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE v. 3 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE v. 3 | Systematic Assessment |
|
| Infection | Infections and infestations | CTCAE v. 3 | Systematic Assessment |
|
| Insomnia | General disorders | CTCAE v. 3 | Systematic Assessment |
|
| Pain - muscle | Musculoskeletal and connective tissue disorders | CTCAE v. 3 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE v. 3 | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTCAE v. 3 | Systematic Assessment |
|
| Pulmonary Symptoms | Respiratory, thoracic and mediastinal disorders | CTCAE v. 3 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE v. 3 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE v. 3 | Systematic Assessment |
|
| Leukocytes | Blood and lymphatic system disorders | CTCAE v. 3 | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE v. 3 | Systematic Assessment |
|
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009930 |
| Organic Chemicals |
| 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 |
| D055585 | Physical Phenomena |
| Title | Measurements |
|---|
|
| Hypertension |
|
| Nausea |
|
| Infection - Other (Pnemonia) |
|
| Pulmonary toxicities |
|
| Leukopenia |
|
| Neutropenia |
|
| Thrombocytopenia |
|