- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00217282
Study of Oxaliplatin and Gemcitabine With or Without Bevacizumab to Treat Advanced Non-Small Cell Lung Cancer
Phase II Trial OF Oxaliplatin and Gemcitabine With Bevacizumab in Advanced Non-Small Cell Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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
- 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.
- Patients must have advanced NSCLC (Stage IIIB with malignant pleural effusion or Stage IV or recurrent disease).
- Patients must have measurable disease (as defined in Section 13.0).
- ECOG performance status 0 or 1.
- Patients must not have known CNS metastases. Brain imaging is required within 4 weeks prior to study entry.
- 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.
Required laboratory values (obtained 2 weeks prior to registration):
7.1 ANC > 1500/mm³. 7.2 Platelets > 100,000/mm³. 7.3 Total Bilirubin < 1.5 mg/dl. 7.4 Transaminases < 5 x ULN.
Patients must have adequate renal function as determined by the following tests within 2 weeks prior to registration.
8.1 Serum creatinine less than or equal to 1.5 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 protein/24 hr to allow participation in the study.
- Patients must be 18 years or older.
- 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.
- 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.
- Patients treated with radiation therapy must have adverse events from therapy resolved to grade 2 or less following completion of treatment.
- Patients must not have ongoing or active infection, symptomatic congestive heart failure, cerebrovascular accident within 12 months, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- 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.
- Patients with history of hypertension must be well-controlled (defined as a blood pressure of >160 mmHg systolic and/or > 110 mmHg diastolic) on a stable regimen of anti-hypertensive therapy.
- Patients must not have serious non-healing wound ulcer, or bone fracture, or major surgical procedure within 3 weeks prior to starting treatment.
- Patients with a history of gross hemoptysis (defined as bright red blood of a ½ teaspoon or more) will be excluded from this trial
- 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 1000mg/m2 IV over 30 minutes, on days 1 and 8 followed by Oxaliplatin 130mg/m2 IV over 2 hours on day 1 followed by Bevacizumab 15 mg/kg 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 mg/kg IV q 3 weeks until relapse/progression
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Florida
-
Miami Beach, Florida, United States, 33140
- Mount Sinai Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Confirmed non-small cell lung cancer, EXCEPT squamous cell cancer
- Stage IIIB or IV disease
- ECOG PS 0-1
- No prior treatment
- No brain metastases
- Must have measurable disease
Exclusion Criteria:
- Deep vein thromboses or pulmonary embolus within 1 year
- History of gross hemoptysis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: Prospective
|
Prospective
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
• To determine the overall response rate • To determine the overall survival. • To determine the toxicity of Gemcitabine, Oxaliplatin given in combination with Bevacizumab
Time Frame: Prospective
|
Prospective
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rogerio Lilenbaum, Icahn School of Medicine at Mount Sinai
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Gemcitabine
- Oxaliplatin
- Bevacizumab
Other Study ID Numbers
- LUN08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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