| ID | Type | Description | Link |
|---|---|---|---|
| 200210637 | Other Identifier | UC Davis | |
| PFIZER-Z1000752 | Other Grant/Funding Number | Pfizer | |
| P30CA093373 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Pfizer | INDUSTRY |
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RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works in treating patients with metastatic or recurrent small cell lung cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (yes vs no) and disease stage (metastatic vs relapsed).
Patients receive irinotecan hydrochloride IV over 90 minutes and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic SCLC | Experimental | Irinotecan 200 mg/m2, every 21 days (intravenous) + Carboplatin AUC = 5 mg/ml x min (intravenous), every 21 days for 6 cycles |
|
| Relapsed SCLC | Experimental | Irinotecan 150 mg/m2 (intravenous), every 21 days + Carboplatin AUC = 5 mg/ml x min (intravenous, every 21 days for 6 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | Patients receive carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by radiographic techniques. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Median Survival of Patients Treated With This Regimen | The length of time from the start of treatment that half of the patients in a group of patients diagnosed with the disease are still alive. | Up to 36 months |
| Number of Participants With Toxicity |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer, meeting 1 of the following criteria:
Previously untreated metastatic or extensive disease
Recurrent disease
Limited, metastatic, or extensive disease
Relapsed after prior chemotherapy, excluding irinotecan hydrochloride
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 1 cm by physical examination or radiographic techniques
Known brain metastases allowed
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Derick H. Lau, MD | University of California, Davis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19204194 | Result | Chen G, Huynh M, Fehrenbacher L, West H, Lara PN Jr, Yavorkovsky LL, Russin M, Goldstein D, Gandara D, Lau D. Phase II trial of irinotecan and carboplatin for extensive or relapsed small-cell lung cancer. J Clin Oncol. 2009 Mar 20;27(9):1401-4. doi: 10.1200/JCO.2008.20.2127. Epub 2009 Feb 9. |
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The recruitment period was 6 years. Subjects were recruited at 4 large medical centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A - Metastatic SCLC (no Previous Chemo) | Extensive small cell lung cancer with no previous chemotherapy |
| FG001 | Arm B - Relapsed SCLC (Previous Chemo) | Relapsed small cell lung cancer with previous chemotherapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | Metastatic small cell lung cancer with no previous chemotherapy |
| BG001 | Arm B | Relapsed small cell lung cancer with previous chemotherapy |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate | Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by radiographic techniques. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | All participants for whom response evaluation measurements were recorded at Baseline and after 2 cycles. | Posted | Number | percentage of participants | Up to 36 months |
|
Up to 36 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 | Arm A | Irinotecan (200 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
Of the 80 patients, 72 were assessable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Analyst | University of California, Davis | 916-734-8053 | nlogihara@ucdavis.edu |
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| 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 |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
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|
| irinotecan | Drug | Patients receive irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. |
|
|
All adverse events were graded according to the National Cancer InstituteCommon Toxicity Criteria, version 2.0. All 80 patients were assessable for toxicity at least for the first cycle.
| Up to 36 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
|
|
| Secondary | Median Survival of Patients Treated With This Regimen | The length of time from the start of treatment that half of the patients in a group of patients diagnosed with the disease are still alive. | All participants for whom response evaluation measurements were recorded at Baseline and after 2 cycles. | Posted | Median | 95% Confidence Interval | months | Up to 36 months |
|
|
|
| Secondary | Number of Participants With Toxicity | All adverse events were graded according to the National Cancer InstituteCommon Toxicity Criteria, version 2.0. All 80 patients were assessable for toxicity at least for the first cycle. | Posted | Count of Participants | Participants | Up to 36 months |
|
|
|
| 2 |
| 40 |
| 40 |
| 40 |
| EG001 | Arm B | Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles | 2 | 40 | 40 | 40 |
| Vomiting | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Neutropenic fever | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Nausea/emesis | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Treatment-related death | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment | Succumbed to sepsis in the setting of neutropenia |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D006571 |
| Heterocyclic Compounds |