Erlotinib + Bevacizumab for PS 2 Chemotherapy Naïve Non-Small Cell Lung Cancer
Part of paid clinical trials in Galesburg, Illinois.
- Sponsor
- Nasser Hanna, M.D.
- Study ID
- NCT00367601
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Erlotinib — DRUGErlotinib 150 mg qd days 1-21
- Bevacizumab — DRUGBevacizumab 15 mg/kg IV, day 1
Study Details
The strategy for combining therapeutic agents in cancer treatments has been successful in multiple tumor types, including NSCLC. Erlotinib and bevacizumab target different pathways involved in tumor growth. Nonclinical studies have demonstrated that the combination of bevacizumab and erlotinib results in greater efficacy than either agent alone. Furthermore, because there is little to no overlap in toxicity profile between the two agents, the combination is expected to be well tolerated and may provide even greater benefit for patients who are unable to receive cytotoxic therapy.
Key Dates
- First listed
- Aug 23, 2006
- Start date
- Aug 31, 2006
- Status verified
- Jan 2016
- Primary completion
- Apr 30, 2008
- Completion
- Dec 31, 2008
Study Design
- Enrollment
- 25 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 1Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
Primary Outcome Measure
To Establish Rate of Non-progressive Disease at 4 Months in Patients With Advanced NSCLC Who Have Been Designated PS2 by Their Treating Physician [ Time Frame: 4 months ]
Locations (13)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Medical & Surgical Specialists, LLC | Galesburg | Illinois | 61401 | - |
| Cancer Care Center of Southern Indiana | Bloomington | Indiana | 47403 | - |
| Oncology Hematology Associates of SW Indiana | Evansville | Indiana | 47714 | - |
| Fort Wayne Oncology & Hematology, Inc | Fort Wayne | Indiana | 46815 | - |
| Community Regional Cancer Center | Indianapolis | Indiana | 46256 | - |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | - |
| Quality Cancer Center (MCGOP) | Indianapolis | Indiana | 46202 | - |
| Arnett Cancer Care | Lafayette | Indiana | 47904 | - |
| Horizon Oncology Center | Lafayette | Indiana | 47905 | - |
| Medical Consultants, P.C. | Muncie | Indiana | 47303 | - |
| Northern Indiana Cancer Research Consortium | South Bend | Indiana | 46601 | - |
| Methodist Cancer Center | Omaha | Nebraska | 68114 | - |
| Oncology Partners Network | Cincinnati | Ohio | 45247 | - |
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