Lung Cancer
Conditions
Brief summary
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.
Detailed description
Upon determination of eligibility, all patients will be receive: * Irinotecan + Carboplatin + Radiation Therapy + Bevacizumab 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.
Interventions
DRUGIrinotecan
50mg/m2 days 1 & 8 each 21-day cycle 1 & 2, 28-day cycle 3 & 4
DRUGCarboplatin
AUC 5
DRUGBevacizumab
10mg/kg IV every 2 weeks for 10 doses starting week 16
RADIATIONRadiation
Sponsors
Genentech, Inc.
Pharmacia and Upjohn
SCRI Development Innovations, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be included in this study, you must meet the following criteria: * Small cell lung cancer, confirmed by biopsy. * Limited stage disease after standard evaluation. * Able to perform activities of daily living without assistance. * No previous treatment with chemotherapy, radiation therapy, or biologics. * Measurable or evaluable disease * Adequate bone marrow, liver and kidney function * Able to understand the nature of this study and give written consent.
Exclusion criteria
You cannot participate in this study if any of the following apply to you: * Age \< 18 years * History of previous malignancies * Women pregnant or lactating * History or physical exam evidence of central nervous system disease) * Active infection requiring intravenous antibiotics * Full-dose anticoagulation or thrombolytic therapy within 10 days * Proteinuria. * Serious nonhealing wound, ulcer, or bone fracture * Evidence if bleeding diathesis or coagulopathy * History of heart attack within 6 months. * Uncontrolled cardiovascular disease * PEG or G-tube * History of other serious disease Please note: There are additional inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC) | 18 months | Toxicity was evaluated in all patients who received at least 1 dose of therapy, and graded according to CTCAE v. 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-Year Progression-free Survival (PFS) | 24 months | 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. |
| Overall Response Rate | 18 month | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 65 years |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 60 / 60 |
| serious Total, serious adverse events | 35 / 60 |
Outcome results
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.
Time frame: 18 months
Population: Patients who received at least one dose of bevacizumab maintenance therapy were assessed for toxicities.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC) | Hemorrhage | 2 Grade 3/4 Toxicity Events |
| Intervention | Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC) | Diarrhea | 1 Grade 3/4 Toxicity Events |
| Intervention | Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC) | Fatigue | 1 Grade 3/4 Toxicity Events |
| Intervention | Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC) | Hypertension | 1 Grade 3/4 Toxicity Events |
| Intervention | Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC) | Nausea | 1 Grade 3/4 Toxicity Events |
| Intervention | Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC) | Infection - Other (Pnemonia) | 4 Grade 3/4 Toxicity Events |
| Intervention | Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC) | Pulmonary toxicities | 4 Grade 3/4 Toxicity Events |
| Intervention | Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC) | Leukopenia | 2 Grade 3/4 Toxicity Events |
| Intervention | Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC) | Neutropenia | 1 Grade 3/4 Toxicity Events |
| Intervention | Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC) | Thrombocytopenia | 1 Grade 3/4 Toxicity Events |
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.
Time frame: 24 months
Population: All patients were assessed for progression free survival.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | 2-Year Progression-free Survival (PFS) | 22 percentage of 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.
Time frame: 18 month
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Overall Response Rate | 80 percentage of participants |