Status:
COMPLETED
Bevacizumab, Docetaxel, and Gemcitabine Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Lead Sponsor:
Nathan Pennell, MD, PhD
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or...
Detailed Description
OBJECTIVES: Primary * Estimate the 1-year progression-free survival rate in patients with stage IIIB, stage IV, or recurrent non-squamous cell non-small cell lung cancer treated with bevacizumab, do...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed non-squamous cell non-small cell lung cancer
- Stage IIIB (with pleural effusion), stage IV, or recurrent disease
- Bidimensionally measurable disease
- No known CNS disease, except for previously treated brain metastasis defined as no evidence of progression or hemorrhage after treatment AND no ongoing requirement for dexamethasone as documented by clinical examination, MRI, or CT scan
- Treatment for brain metastases may have included whole brain radiotherapy, radiosurgery (gamma knife, LINAC, or equivalent), or a combination of therapy as deemed appropriate by the treating physician
- Stable dose of anticonvulsants allowed
- No known metastatic disease to the gastrointestinal tract (e.g., stomach, small bowel, or large bowel)
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy \> 3 months
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL
- Bilirubin ≤ 2.0 mg/dL
- AST or ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5.0 times ULN if hepatic metastases are present)
- Serum creatinine ≤ 1.8 mg/dL
- Urine protein:creatinine ratio \< 1.0 OR proteinuria \< 2+ by urine dipstick OR ≤ 1 g of protein by 24-hour urine collection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Available for regular follow-ups
- No inadequately controlled hypertension, defined as systolic BP \> 150 mm Hg and/or diastolic BP \> 100 mm Hg despite antihypertensive medications
- No history of hypertensive crisis or hypertensive encephalopathy
- No NYHA class II-IV congestive heart failure
- No myocardial infarction or unstable angina within the past 6 months
- No stroke or transient ischemic attack within the past 6 months
- No significant vascular disease (e.g., aortic aneurysm, aortic dissection requiring surgical repair, or recent peripheral arterial thrombosis) within the past 6 months
- No symptomatic peripheral vascular disease
- No evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
- No history of colonic diverticular disease (i.e., diverticulosis or diverticulitis)
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No serious, nonhealing wound, ulcer, or bone fracture
- No known hypersensitivity to any component of bevacizumab
- No hemoptysis (bright red blood of ≥ ½ teaspoon per episode) within the past 3 months
- No significant traumatic injury within the past 28 days
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or biological therapy
- No prior radiotherapy to an area of measurable disease unless there is documented progressive disease after completion of therapy
- More than 2 weeks since prior radiotherapy
- More than 4 weeks since prior and no concurrent participation in another experimental drug study, except for a Genentech-sponsored bevacizumab cancer study
- More than 28 days since prior major surgical procedure or open biopsy
- More than 3 months since prior abdominal surgery
- More than 3 months since prior neurosurgical resection or brain biopsy
- More than 7 days since prior core biopsy or other minor surgical procedure, except placement of a vascular access device
- No concurrent major surgical procedure
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00970684
Start Date
September 1 2009
End Date
September 1 2011
Last Update
August 16 2022
Active Locations (4)
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1
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
2
Fairview Hospital, Moll Pavilion
Cleveland, Ohio, United States, 44111
3
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
4
Hillcrest Hospital, a Cleveland Clinic Hospital
Mayfield Heights, Ohio, United States, 44124