- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00766246
Phase II Avastin Trial for Stage IIIB/IV NSCLC
April 18, 2016 updated by: Pharmatech
A Multicenter, Open-Label, Randomized, Phase II Trial of Docetaxel, Carboplatin and Bevacizumab as First-Line Treatment, Followed by Bevacizumab Plus Pemetrexed Versus Pemetrexed Alone as Second-Line Treatment of Stage IIIB or IV Non-Small Cell Lung Cancer
This is a randomized, open-label, multicenter study in 160 patients in first line treatment and 114 in second line treatment with advanced or metastatic NSCLC (Stage IIIB/IV).
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
This phase II clinical trial will address the issues of bevacizumab treatment duration and treatment safety as first-line therapy for patients with non-squamous NSCLC.
Following disease progression or treatment failure, the potential benefit of continued bevacizumab therapy will be tested by randomizing patients to two treatment arms, including second-line chemotherapy with or without further bevacizumab.
It is hypothesized that continuation of bevacizumab with pemetrexed as second-line treatment following progression will result in improved clinical outcomes for patients with NSCLC.
Study Type
Interventional
Enrollment (Actual)
125
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥ 18 years
- Histologically or cytologically confirmed stage IIIB with malignant pleural effusion or stage IV NSCLC except squamous-cell carcinoma
- Measurable disease defined by RECIST
Adequate organ function:
- Absolute neutrophil count ≥ 1.5 x 10(9)/L
- Hemoglobin ≥ 9.0 g/dL
- Platelets ≥ 100 x 10(9)/L
- Hepatic enzyme levels: AST and ALT and Alkaline Phosphatase must be within range allowing for eligibility. In determining eligibility, the more abnormal of the two values (AST or ALT) should be used according to table listed in the protocol
- Bilirubin ≤ ULN
- Serum Creatinine ≤ 1.5 mg/dL (or creatinine clearance ≥ 60mL/min)
- Urine protein/creatinine ratio < 1.0 OR urine dipstick for proteinuria < 2 + (patients discovered to have ≥ 2 + proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤1g of protein in 24 hours to be eligible)
- INR ≤ 1.5
- PTT ≤ ULN
- ECOG Performance Status 0-1
- Estimated survival of ≥ 12 weeks
- Provide written informed consent
Exclusion Criteria:
- Prior chemotherapy for advanced NSCLC
- Neoadjuvant or adjuvant treatment within six (6) months of registration
- Prior radiation therapy within three (3) weeks of registration; all side effects must have resolved by registration
- Prior treatment with an investigational or marketed agent that acts by antiangiogenesis mechanisms
- Large ( > 4 cm) centrally located lesions or large lesions in close proximity to major blood vessels unless treated with palliative radiation
- Brain metastases or leptomeningeal disease, except for patients who have had a resection and/or completed a course of cranial irradiation, have no worsening CNS symptoms, and have discontinued all corticosteroids for that indication for at least one (1) month prior to registration
- History of gross hemoptysis (defined as bright red blood of at least ½ teaspoon or 2.5 mL per episode) within three (3) months of registration unless definitively treated with surgery, radiation, arteriographic embolization, or endobronchial interventions at least four (4) weeks prior to registration
- Presence of cavitory lesion
- Presence of squamous histology (mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; sputum cytology alone is not acceptable)
- Peripheral neuropathy > grade 1
- Major surgery, open biopsy or significant traumatic injury within four (4) weeks of registration or anticipation of need for major surgical procedure during the course of the study
- Minor surgical procedures, fine needle aspirations or core biopsies within one (1) week prior to registration
- Current, ongoing therapeutic anticoagulation with full-dose warfarin or its equivalent
- Current or recent (within ten [10] days of the first dose of study treatment) use of aspirin (at least 325 mg/day) or other NSAIDs with anti-platelet activity or treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix), or cilostazol (Pletal)
- History of prior malignancy within the past three (3) years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or treated localized prostate cancer with a current PSA of < 1.0 mg/dL on two successive evaluations, at least three (3) months apart, with the most recent evaluation no more than four (4) weeks prior to registration
History of serious systemic disease including:
- Unstable angina, New York Heart Association (NYHA) ≥ Grade II or congestive heart failure
- Inadequately controlled hypertension (blood pressure >150/100 mmHg while taking antihypertensive medications)
- Unstable symptomatic arrhythmia requiring medication
- Myocardial infarction within six (6) months prior to registration
- Stroke within six (6) months prior to registration
- Transient ischemic attack within six (6) months prior to registration
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within six (6) months prior to registration
- Clinically significant peripheral vascular disease or evidence of bleeding, diathesis (prone to bleeding) or coagulopathy
- Active systemic bacterial, fungal or viral infection, including known HCV and HIV
- Pregnancy or women who are breast-feeding; women of child-bearing potential and non-vasectomized men must agree to use effective methods of birth control during and three (3) months following treatment period and women of child-bearing potential must have a negative pregnancy test
- History of severe hypersensitivity reaction to docetaxel or any other drugs formulated with polysorbate 80
- Any other medical condition, including mental illness or substance abuse, which in the judgment of the investigator, is likely to interfere with a patient's ability to provide informed consent, cooperate, and participate in the study, or to interfere with the interpretation of the results
- Use of any investigational agent within four (4) weeks prior to registration
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: First-line
Carboplatin, docetaxel, bevacizumab Open-label, single arm with treatment period up to 6 cycles.
Patients completing a total of 2 to 6 cycles of first-line without disease progression will be eligible for maintenance.
|
15 mg/kg administered in 21 day cycles on day 1 of each cycle for first-line and maintenance
Other Names:
75 mg/m2 administered in 21-day cycles on day 1 of each cycle for first line treatment
Other Names:
AUC=6 administered in 21-day cycles on day 1 of each cycle for first-line treatment
Other Names:
|
Experimental: Maintenance
Bevacizumab Open-label, single arm with treatment period up to 18 cycles.
|
15 mg/kg administered in 21 day cycles on day 1 of each cycle for first-line and maintenance
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival (PFS) of bevacizumab and pemetrexed compared to pemetrexed monotherapy during second-line treatment of Stage IIIB or IV NSCLC
Time Frame: Duration of study
|
Duration of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival (OS)
Time Frame: Duration of the study
|
Duration of the study
|
Objective tumor response (objective response rate [ORR]) in second-line treatment
Time Frame: Duration of the study
|
Duration of the study
|
Progression-free survival (PFS) in first-line and maintenance treatment
Time Frame: Duration of the study
|
Duration of the study
|
Objective tumor response (objective response rate [ORR]) in first-line and maintenance treatment
Time Frame: Duration of the study
|
Duration of the study
|
Treatment safety in first-line, maintenance and second-line treatment
Time Frame: Duration of the study
|
Duration of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chandra P Belani, MD, Penn State Milton S. Hershey Medical Center, Penn State College of Medicine, Penn State Hershey Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
October 1, 2008
First Submitted That Met QC Criteria
October 2, 2008
First Posted (Estimate)
October 3, 2008
Study Record Updates
Last Update Posted (Estimate)
April 19, 2016
Last Update Submitted That Met QC Criteria
April 18, 2016
Last Verified
April 1, 2016
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
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Docetaxel
- Carboplatin
- Bevacizumab
Other Study ID Numbers
- PSHCI 08-009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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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