Bevacizumab and Docetaxel in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Completed · Phase 2
Conditions studied: Lung Cancer
In brief
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 carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, also work in different ways to kill tumor cells or stop them from growing. Giving bevacizumab together with docetaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel works in treating older patients with stage III or stage IV non-small cell lung cancer.
Key facts
- Study ID
- NCT00541099
- Run by
- Barbara Ann Karmanos Cancer Institute
- People needed
- 11
- Starts
- 2008-01-01
- Expected to finish
- 2013-01-01
- Last updated by the study team
- 2019-03-27
Who can join
Age: 75 and older, up to 120. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed non-small cell lung cancer
- Stage III or IV disease
- Stage III disease allowed, provided the patient is not a candidate for concurrent chemotherapy and radiotherapy
- Mixed histology allowed, provided the biopsy has less than 50% squamous cell histology
- Measurable or evaluable disease
You may not qualify if…
- Squamous cell histology
- Evidence of cavitation in the tumor
- Tumors in close proximity to major blood vessels
- No active, untreated brain metastases
- More than 7 days since prior treatment for brain metastases AND no evidence of hemorrhage in the lesion
- Stable or declining dose of steroids allowed
- PATIENT CHARACTERISTICS:
- Inclusion criteria:
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy > 12 weeks
- Leukocytes ≥ 3,000/μL
- Absolute neutrophil count ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN (< 5 times ULN if patients has liver metastases)
- Creatinine ≤ 1.5 times normal
- Left ventricular function ≥ normal by MUGA scan or ECHO
- Urine protein:creatinine ratio ≤ 1.0 AND/OR urine protein ≤ 1+ by dipstick analysis OR protein ≤ 1 g/24-hour urine collection
- Fertile patients must use effective contraception and women should avoid breastfeeding
- Exclusion criteria:
- Resting blood pressure (BP) consistently > 140/90 mm Hg
- Patients whose BP is controlled (≤ 140 mm Hg systolic and ≤ 90 mm Hg diastolic) after adjusting, starting, or increasing the medications are eligible
- Significant hemorrhage (i.e., > 30 mL bleeding/episode ) or hemoptysis (i.e., > 5 mL fresh blood in one episode) in the previous 3 months
- Evidence of bleeding diathesis or coagulopathy
- Significant traumatic injury within the past 28 days
Where it is running
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
- Nevada Cancer Institute — Las Vegas, Nevada, United States
- Case Comprehensive Cancer Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.