Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217282
Status:
COMPLETED
Last Update Posted:
2008-05-22
First Post:
2005-09-14
Brief Title:
Study of Oxaliplatin and Gemcitabine With or Without Bevacizumab to Treat Advanced Non-Small Cell Lung Cancer
Sponsor:
Mt Sinai Medical Center Miami
Organization:
Mt Sinai Medical Center Miami
Study Overview
Official Title:
Phase II Trial OF Oxaliplatin and Gemcitabine With Bevacizumab in Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The combination of oxaliplatin and gemcitabine has proven activity in advanced non-small cell lung cancer NSCLC Due to its favorable toxicity profile this combination is optimal for adding new agents Bevacizumab is an anti-VEGF monoclonal antibody that has also shown favorable results in advanced NSCLC This study will add bevacizumab to oxaliplatin and gemcitabine as first line treatment in patients with Stage IIIB and IV NSCLC
Detailed Description:
STUDY OBJECTIVES
Primary
To determine the overall time to progression of the combination regimen of Gemcitabine Oxaliplatin and Bevacizumab as first-line treatment in patients with Stage IIIB and IV non-small cell lung cancer
Secondary
To determine the overall response rate
To determine the overall survival
To determine the toxicity of Gemcitabine Oxaliplatin given in combination with Bevacizumab
ELIGIBILITY CRITERIA
1 Patients must have histologically or cytologically confirmed non-small cell lung cancer EXCEPT squamous cell carcinoma Mixed tumors will be categorized by the predominant cell type unless small cell elements are present in which case the patient is ineligible Cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy
2 Patients must have advanced NSCLC Stage IIIB with malignant pleural effusion or Stage IV or recurrent disease
3 Patients must have measurable disease as defined in Section 130
4 ECOG performance status 0 or 1
5 Patients must not have known CNS metastases Brain imaging is required within 4 weeks prior to study entry
6 No prior systemic treatment for advanced NSCLC is permitted Prior treatment for early-stage disease adjuvant or for locally-advanced Stage III disease is allowed if completed at least 12 months prior to registration
7 Required laboratory values obtained 2 weeks prior to registration
71 ANC 1500mm³ 72 Platelets 100000mm³ 73 Total Bilirubin 15 mgdl 74 Transaminases 5 x ULN
8 Patients must have adequate renal function as determined by the following tests within 2 weeks prior to registration
81 Serum creatinine less than or equal to 15 x upper limit of normal ULN AND Urinalysis 1 protein
Patients discovered to have 1 proteinuria at baseline must undergo a 24-hour urine collection This must be an adequate collection and must demonstrate 1g of protein24 hr to allow participation in the study
9 Patients must be 18 years or older
10 Pregnant and lactating women are excluded from the study because the agents used in this study may be teratogenic to a fetus and there is no information on the excretion of the agents or their metabolites into breast milk A negative urine or serum pregnancy test required for women of childbearing potential
11 Women of childbearing potential and sexually active males must agree 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
12 Patients treated with radiation therapy must have adverse events from therapy resolved to grade 2 or less following completion of treatment
13 Patients must not have ongoing or active infection symptomatic congestive heart failure cerebrovascular accident within 12 months unstable angina pectoris cardiac arrhythmia or psychiatric illnesssocial situations that would limit compliance with study requirements
14 Patients must have no deep vein thrombosis or pulmonary embolus within one year of registration and no ongoing need for full-dose oral or parenteral anticoagulation Low dose coumadin 1mg for maintenance of catheter patency or daily prophylactic aspirin is allowed
15 Patients with history of hypertension must be well-controlled defined as a blood pressure of 160 mmHg systolic andor 110 mmHg diastolic on a stable regimen of anti-hypertensive therapy
16 Patients must not have serious non-healing wound ulcer or bone fracture or major surgical procedure within 3 weeks prior to starting treatment
17 Patients with a history of gross hemoptysis defined as bright red blood of a ½ teaspoon or more will be excluded from this trial
18 No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer in situ cervical cancer or other cancer for which the patient has been disease-free for five years
TREATMENT PLAN Gemcitabine 1000mgm2 IV over 30 minutes on days 1 and 8 followed by Oxaliplatin 130mgm2 IV over 2 hours on day 1 followed by Bevacizumab 15 mgkg IV over 90 minutes on day 1 Cycles q 3 weeks x 4 cycles One cycle equals 3 weeks Patients will be re-evaluated every 2 cycles If CR PR or SD patients will continue treatment up to four cycles or until progression or unacceptable toxicity
Patients achieving CR PR or SD after 4 cycles will continue Bevacizumab maintenance
Bevacizumab 15 mgkg IV q 3 weeks until relapseprogression
Primary
To determine the overall time to progression of the combination regimen of Gemcitabine Oxaliplatin and Bevacizumab as first-line treatment in patients with Stage IIIB and IV non-small cell lung cancer
Secondary
To determine the overall response rate
To determine the overall survival
To determine the toxicity of Gemcitabine Oxaliplatin given in combination with Bevacizumab
ELIGIBILITY CRITERIA
1 Patients must have histologically or cytologically confirmed non-small cell lung cancer EXCEPT squamous cell carcinoma Mixed tumors will be categorized by the predominant cell type unless small cell elements are present in which case the patient is ineligible Cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy
2 Patients must have advanced NSCLC Stage IIIB with malignant pleural effusion or Stage IV or recurrent disease
3 Patients must have measurable disease as defined in Section 130
4 ECOG performance status 0 or 1
5 Patients must not have known CNS metastases Brain imaging is required within 4 weeks prior to study entry
6 No prior systemic treatment for advanced NSCLC is permitted Prior treatment for early-stage disease adjuvant or for locally-advanced Stage III disease is allowed if completed at least 12 months prior to registration
7 Required laboratory values obtained 2 weeks prior to registration
71 ANC 1500mm³ 72 Platelets 100000mm³ 73 Total Bilirubin 15 mgdl 74 Transaminases 5 x ULN
8 Patients must have adequate renal function as determined by the following tests within 2 weeks prior to registration
81 Serum creatinine less than or equal to 15 x upper limit of normal ULN AND Urinalysis 1 protein
Patients discovered to have 1 proteinuria at baseline must undergo a 24-hour urine collection This must be an adequate collection and must demonstrate 1g of protein24 hr to allow participation in the study
9 Patients must be 18 years or older
10 Pregnant and lactating women are excluded from the study because the agents used in this study may be teratogenic to a fetus and there is no information on the excretion of the agents or their metabolites into breast milk A negative urine or serum pregnancy test required for women of childbearing potential
11 Women of childbearing potential and sexually active males must agree 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
12 Patients treated with radiation therapy must have adverse events from therapy resolved to grade 2 or less following completion of treatment
13 Patients must not have ongoing or active infection symptomatic congestive heart failure cerebrovascular accident within 12 months unstable angina pectoris cardiac arrhythmia or psychiatric illnesssocial situations that would limit compliance with study requirements
14 Patients must have no deep vein thrombosis or pulmonary embolus within one year of registration and no ongoing need for full-dose oral or parenteral anticoagulation Low dose coumadin 1mg for maintenance of catheter patency or daily prophylactic aspirin is allowed
15 Patients with history of hypertension must be well-controlled defined as a blood pressure of 160 mmHg systolic andor 110 mmHg diastolic on a stable regimen of anti-hypertensive therapy
16 Patients must not have serious non-healing wound ulcer or bone fracture or major surgical procedure within 3 weeks prior to starting treatment
17 Patients with a history of gross hemoptysis defined as bright red blood of a ½ teaspoon or more will be excluded from this trial
18 No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer in situ cervical cancer or other cancer for which the patient has been disease-free for five years
TREATMENT PLAN Gemcitabine 1000mgm2 IV over 30 minutes on days 1 and 8 followed by Oxaliplatin 130mgm2 IV over 2 hours on day 1 followed by Bevacizumab 15 mgkg IV over 90 minutes on day 1 Cycles q 3 weeks x 4 cycles One cycle equals 3 weeks Patients will be re-evaluated every 2 cycles If CR PR or SD patients will continue treatment up to four cycles or until progression or unacceptable toxicity
Patients achieving CR PR or SD after 4 cycles will continue Bevacizumab maintenance
Bevacizumab 15 mgkg IV q 3 weeks until relapseprogression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None