Back to resultsA Study of Cetuximab and Bevacizumab in Combination With Paclitaxel and Carboplatin in Stage IIIb/IV NSCLC
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cetuximab
Bevacizumab
Paclitaxel
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Non-Small Cell Lung Cancer, Malignant pleural effusions
Eligibility Criteria
Inclusion Criteria: The patient has histologically or cytologically confirmed non-small cell lung cancer (NSCLC), except squamous cell carcinoma. Mixed tumors will be categorized by the predominant cell type, but the presence of small cell lung cancer elements will make the patient ineligible. Cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy. The patient has advanced NSCLC (Stage IIIB with malignant pleural effusion or Stage IV or recurrent disease). Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST). The patient's Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1. The patient has adequate hematologic function as defined by an Absolute Neutrophil Count greater than or equal to 1500/mm³,hemoglobin greater than or equal to 9 gm/dL, and a platelet count greater than or equal to 100,000/mm³ obtained within 2 weeks prior to the first dose of study medication. The patient has adequate hepatic function as defined by a total bilirubin greater than or equal to 1.5 mg/dL and transaminases and alkaline phosphatase less than or equal to 5 x the Upper Limit of Normal (ULN) obtained within 2 weeks prior to the first dose of study medication. The patient has adequate renal function as defined by serum creatinine less than or equal to 1.5 x ULN or calculated creatinine clearance (CrCl) >60 mL/minute, and urine dipstick for proteinuria <1+ (ie, either 0 or trace) obtained within 2 weeks prior to the first dose of study medication. If urine dipstick is greater than or equal to 1+, then a 24-hour urine for protein must demonstrate <500 mg of protein in 24 hours to allow participation in the study. The patient has adequate coagulation function as defined by International Normalized Ratio less than or equal to 1.5 and a Prothrombin time and partial thromboplastin time less than or equal to ULN obtained within 2 weeks prior to the first dose of study medication. The patient, if a woman of childbearing potential, agrees to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study. If a male and sexually active, the patient agrees to use effective contraception. Exclusion Criteria: The patient has known Central Nervous System metastases. A head computed tomography (CT) is required within 4 weeks prior to the first dose of study medication (magnetic resonance imagines [MRIs] are also acceptable). The patient has received prior cetuximab therapy. The patient has received prior bevacizumab therapy. The patient has received prior systemic chemotherapy or radiation therapy at any time for lung cancer. Any concurrent malignancy other than basal cell skin cancer, or carcinoma in situ of the cervix. Patients with adequately treated cancers of other histologies who have been disease-free for more than 3 years prior to the first treatment dose are eligible. Concurrent treatment with other anti-cancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy. The patient has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. The patient has a history of thrombotic or hemorrhagic disorders. The patient has uncontrolled hypertension (>150/100 mmHg) on a standard regimen of anti-hypertensive therapy. The patient is receiving chronic daily treatment with aspirin (>325 mg/day) or nonsteroidal anti-inflammatory agents known to inhibit platelet function. The patient is receiving treatment with dipyridamole (Persantine®), ticlopidine (Ticlid®), clopidogrel (Plavix®) and /or cilostazol (Pletal®). The patient is receiving anti-coagulation therapy. Prophylactic anti-coagulation of venous access devices is allowed. Caution should be taken on treating patients with low dose heparin or low molecular weight heparin for deep vein thrombosis (DVT) prophylaxis during treatment with bevacizumab as there may be an increased risk of bleeding. Patients with a history of gross hemoptysis (defined as bright red blood or greater than or equal to ½ teaspoon). The patient has a serious non-healing wound ulcer, bone fracture, or major surgical procedure within 30 days prior to first dose of study medication. Elective or planned major surgery to be performed during the course of the trial. The patient has a pre-existing neuropathy >grade 1. The patient, if a woman, is pregnant or lactating.
Sites / Locations
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)
Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)
Arm Description
Cycles 1-6: Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle Paclitaxel 200 mg/m² on day 1 of every 3 week cycle Carboplatin area under curve (AUC=6 min*mg/mL) on day 1 of every 3 week cycle Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met
Cycles 1-6: Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle Cycles 1-3: Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS)
PFS is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD ≥20% increase in sum of longest diameter of target lesions. Participants who are alive and without PD will be censored at the date of their last tumor assessment.
Secondary Outcome Measures
Overall Survival
Overall survival is defined as the time from randomization to death. Participants who are alive will be censored on the last known alive date.
Percentage of Participants Achieving an Objective Overall Response (Overall Response Rate)
The best objective overall response rate (ORR) is the percentage of randomized participants with a best overall response of complete response (CR) or partial response (PR), as classified by the investigator according to the RECIST guidelines. CR=disappearance of all target lesions; PR≥30% decrease in sum of longest diameter of target lesions. ORR is calculated as a total number of participants with CR or PR divided by the total number of participants treated in that arm, multiplied by 100. Participants with no post-baseline evaluation will be considered as a non-responder.
Duration of Overall Response
The duration of response, in participants with best overall response of CR or PR, is measured from the date criteria are met for CR/PR (whichever is first recorded), until the first date that the criteria for PD is met or death. CR, PR, and PD, as classified by the investigator according to the RECIST guidelines. CR=disappearance of all target lesions; PR≥30% decrease in sum of longest diameter of target lesions; PD≥20% increase in sum of longest diameter of target lesions. Participants who are alive and without PD will be censored at the date of their last tumor assessment.
Percentage of Participants With Symptomatic Response (Symptom Response Rate)
Functional Assessment of Cancer Therapy for Patients With Lung Cancer (FACT-L) measures domains of health-related quality of life (HR-QL): physical wellbeing (WB), social/family WB, emotional WB, functional WB, and additional lung cancer concerns. Symptom response (improvement) was defined as ≥2 point increase from baseline in the 7-item Lung cancer subscale (LCS) score maintained for 2 consecutive assessments. Scores range from 0-28 with higher scores indicating fewer symptoms. Patients with a score of >26 were not evaluable for symptom response, since a score of 28 is the maximum possible.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00343291
Brief Title
A Study of Cetuximab and Bevacizumab in Combination With Paclitaxel and Carboplatin in Stage IIIb/IV NSCLC
Official Title
Phase II Randomized, Open-Label Study of Cetuximab and Bevacizumab in Combination With Paclitaxel and Carboplatin in Patients With Stage IIIB/IV Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study will be to determine the progression free survival of patients with stage IIIb/IV non-small cell lung cancer (NSCLC) treated with dual agent monoclonal antibody therapy consisting of cetuximab and bevacizumab in combination with two different regimens of paclitaxel and carboplatin chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Non-Small Cell Lung Cancer, Malignant pleural effusions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)
Arm Type
Active Comparator
Arm Description
Cycles 1-6:
Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle
Paclitaxel 200 mg/m² on day 1 of every 3 week cycle
Carboplatin area under curve (AUC=6 min*mg/mL) on day 1 of every 3 week cycle
Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met
Arm Title
Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)
Arm Type
Active Comparator
Arm Description
Cycles 1-6:
Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle
Cycles 1-3:
Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles
Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles
Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met
Intervention Type
Biological
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
Administered intravenously
Intervention Type
Biological
Intervention Name(s)
Bevacizumab
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Administered intravenously
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD ≥20% increase in sum of longest diameter of target lesions. Participants who are alive and without PD will be censored at the date of their last tumor assessment.
Time Frame
Randomization to PD or date of death from any cause up to 33.1 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival is defined as the time from randomization to death. Participants who are alive will be censored on the last known alive date.
Time Frame
Randomization to the date of death from any cause up to 42.7 months
Title
Percentage of Participants Achieving an Objective Overall Response (Overall Response Rate)
Description
The best objective overall response rate (ORR) is the percentage of randomized participants with a best overall response of complete response (CR) or partial response (PR), as classified by the investigator according to the RECIST guidelines. CR=disappearance of all target lesions; PR≥30% decrease in sum of longest diameter of target lesions. ORR is calculated as a total number of participants with CR or PR divided by the total number of participants treated in that arm, multiplied by 100. Participants with no post-baseline evaluation will be considered as a non-responder.
Time Frame
Randomization to measured progressive disease up to 31.8 months
Title
Duration of Overall Response
Description
The duration of response, in participants with best overall response of CR or PR, is measured from the date criteria are met for CR/PR (whichever is first recorded), until the first date that the criteria for PD is met or death. CR, PR, and PD, as classified by the investigator according to the RECIST guidelines. CR=disappearance of all target lesions; PR≥30% decrease in sum of longest diameter of target lesions; PD≥20% increase in sum of longest diameter of target lesions. Participants who are alive and without PD will be censored at the date of their last tumor assessment.
Time Frame
Time of first response to the first date of PD or death due to any cause up to 31.8 months
Title
Percentage of Participants With Symptomatic Response (Symptom Response Rate)
Description
Functional Assessment of Cancer Therapy for Patients With Lung Cancer (FACT-L) measures domains of health-related quality of life (HR-QL): physical wellbeing (WB), social/family WB, emotional WB, functional WB, and additional lung cancer concerns. Symptom response (improvement) was defined as ≥2 point increase from baseline in the 7-item Lung cancer subscale (LCS) score maintained for 2 consecutive assessments. Scores range from 0-28 with higher scores indicating fewer symptoms. Patients with a score of >26 were not evaluable for symptom response, since a score of 28 is the maximum possible.
Time Frame
From date of partial response until progression of disease up to 31.8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient has histologically or cytologically confirmed non-small cell lung cancer (NSCLC), except squamous cell carcinoma. Mixed tumors will be categorized by the predominant cell type, but the presence of small cell lung cancer elements will make the patient ineligible. Cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy.
The patient has advanced NSCLC (Stage IIIB with malignant pleural effusion or Stage IV or recurrent disease).
Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
The patient's Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1.
The patient has adequate hematologic function as defined by an Absolute Neutrophil Count greater than or equal to 1500/mm³,hemoglobin greater than or equal to 9 gm/dL, and a platelet count greater than or equal to 100,000/mm³ obtained within 2 weeks prior to the first dose of study medication.
The patient has adequate hepatic function as defined by a total bilirubin greater than or equal to 1.5 mg/dL and transaminases and alkaline phosphatase less than or equal to 5 x the Upper Limit of Normal (ULN) obtained within 2 weeks prior to the first dose of study medication.
The patient has adequate renal function as defined by serum creatinine less than or equal to 1.5 x ULN or calculated creatinine clearance (CrCl) >60 mL/minute, and urine dipstick for proteinuria <1+ (ie, either 0 or trace) obtained within 2 weeks prior to the first dose of study medication. If urine dipstick is greater than or equal to 1+, then a 24-hour urine for protein must demonstrate <500 mg of protein in 24 hours to allow participation in the study.
The patient has adequate coagulation function as defined by International Normalized Ratio less than or equal to 1.5 and a Prothrombin time and partial thromboplastin time less than or equal to ULN obtained within 2 weeks prior to the first dose of study medication.
The patient, if a woman of childbearing potential, agrees to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study. If a male and sexually active, the patient agrees to use effective contraception.
Exclusion Criteria:
The patient has known Central Nervous System metastases. A head computed tomography (CT) is required within 4 weeks prior to the first dose of study medication (magnetic resonance imagines [MRIs] are also acceptable).
The patient has received prior cetuximab therapy.
The patient has received prior bevacizumab therapy.
The patient has received prior systemic chemotherapy or radiation therapy at any time for lung cancer.
Any concurrent malignancy other than basal cell skin cancer, or carcinoma in situ of the cervix. Patients with adequately treated cancers of other histologies who have been disease-free for more than 3 years prior to the first treatment dose are eligible.
Concurrent treatment with other anti-cancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy.
The patient has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
The patient has a history of thrombotic or hemorrhagic disorders.
The patient has uncontrolled hypertension (>150/100 mmHg) on a standard regimen of anti-hypertensive therapy.
The patient is receiving chronic daily treatment with aspirin (>325 mg/day) or nonsteroidal anti-inflammatory agents known to inhibit platelet function.
The patient is receiving treatment with dipyridamole (Persantine®), ticlopidine (Ticlid®), clopidogrel (Plavix®) and /or cilostazol (Pletal®).
The patient is receiving anti-coagulation therapy. Prophylactic anti-coagulation of venous access devices is allowed. Caution should be taken on treating patients with low dose heparin or low molecular weight heparin for deep vein thrombosis (DVT) prophylaxis during treatment with bevacizumab as there may be an increased risk of bleeding.
Patients with a history of gross hemoptysis (defined as bright red blood or greater than or equal to ½ teaspoon).
The patient has a serious non-healing wound ulcer, bone fracture, or major surgical procedure within 30 days prior to first dose of study medication.
Elective or planned major surgery to be performed during the course of the trial.
The patient has a pre-existing neuropathy >grade 1.
The patient, if a woman, is pregnant or lactating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Decatur
State/Province
Alabama
ZIP/Postal Code
35601
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
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City
Grass Valley
State/Province
California
ZIP/Postal Code
95945
Country
United States
Facility Name
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City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
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City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
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City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
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City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
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City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
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City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
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City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
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City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
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City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
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City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
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City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
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City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
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City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
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City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40215
Country
United States
Facility Name
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City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
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City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
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City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
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City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
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City
Lambertville
State/Province
Michigan
ZIP/Postal Code
48144
Country
United States
Facility Name
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City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
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City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
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City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
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City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
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City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
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City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
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City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
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City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
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City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
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City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
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City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
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City
Hilton Head Island
State/Province
South Carolina
ZIP/Postal Code
29926
Country
United States
Facility Name
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City
MT Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
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City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
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City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
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City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Facility Name
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City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
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City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Cetuximab and Bevacizumab in Combination With Paclitaxel and Carboplatin in Stage IIIb/IV NSCLC
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