Study of Bevacizumab and Erlotinib in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
This study has been completed.
Sponsor:
Fox Chase Cancer Center
Collaborators:
Genentech
OSI Pharmaceuticals
Information provided by:
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00553800
First received: November 5, 2007
Last updated: June 18, 2013
Last verified: May 2013
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Purpose
This study will evaluate the combination of bevacizumab and erlotinib in elderly patients with advanced non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung |
Drug: bevacizumab and erlotinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Bevacizumab and Erlotinib in Elderly Patients With Advanced Non-Small Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Fox Chase Cancer Center:
Primary Outcome Measures:
- Efficacy measure is progression free survival defined as the time from enrollment to documented progression of disease by radiologic imaging. [ Time Frame: Scans to be done after every 2nd cycle of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- toxicity [ Time Frame: every 3 weeks at day 1 physician exam and in between as needed ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 33 |
| Study Start Date: | March 2007 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: bevacizumab and erlotinib
- Avastin
- Tarceva
bevacizumab at 15mg/kg IV on day 1 of each 21 day cycle with erlotinib 150 mg tablets once a day throughout treatment.
Other Names:
There is no definite evidence of a superior therapy for advanced non-small cell lung cancer in elderly patients. With the exception of one known study, single agent erlotinib has not been studied exclusively in the elderly and the combination of erlotinib and bevacizumab has never been studied exclusively in the treatment naive elderly. This is an important population that needs less toxic therapies.
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Cytologically or histologic confirmed non-small cell lung cancer, stage IIIB or IV or recurrent after primary surgery or radiotherapy.
- ECOG PS 0-1
- 70 years of age or older
- Must have measurable disease
- ANC > 1500, platelets > 100,000
- Total bilirubin </= 1.5, SGOT * SGPT < 5 x ULN
- Able and willing to swallow and absorb oral medication
- Able and willing to sign consent
- Request archival diagnostic tissue for EGFR expression but not required
Exclusion Criteria:
- Proteinuria as demonstrated by UPC ratio >/= 1.0
- Prior treatment with an investigational or marketed inhibitor of the EGFR pathway or anti-angiogenesis agent (includes thalidomide)
- Prior treatment for advanced stage disease, with the exception of surgery or radiation (no systemic)
- History of gross hemoptysis within 1 month of enrollment unless treated with surgery or radiation
- Evidence of bleeding diathesis or coagulopathy or other serious/acute internal bleeding within 6 months of enrollment.
- Current, ongoing treatment with full dose warfarin or equivalent
- Current(within 10 days)use of aspirin (> 325mg/day) or other NSAID with antiplatelet activity
- History of hemorrhagic or thrombotic stoke, TIA, or other CNS bleeding w/in last 6 months. Clinically significant PVD
- Known CNS disease except for treated brain mets.
- Squamous cell histology
- Blood pressure > 150/100 that cannot be ameliorated with standard anti-hypertensives
- History of hypertensive crisis or hypertensive encephalopathy
- NYHA grade II or > CHF
- History of MI within 6 months of enrollment
- Major surgery, open biopsy, significant trauma within 28 days of enrollment
- Pregnancy, lactation
- Abdominal or other fistula, abcess, perforation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553800
Locations
| United States, New Jersey | |
| AtlantiCare Regional Medical Center | |
| Galloway, New Jersey, United States, 08205 | |
| Fox Chase Virtua Health Cancer Program at Memorial | |
| Mount Holly, New Jersey, United States, 08060 | |
| United States, Pennsylvania | |
| Paoli Hospital | |
| Paoli, Pennsylvania, United States, 19301 | |
| Abramson Cnacer Center, University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Pennsylvania Oncology Hematology Associates | |
| Philadelphia, Pennsylvania, United States, 19106 | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Grand View Hospital | |
| Sellersville, Pennsylvania, United States, 18960 | |
Sponsors and Collaborators
Fox Chase Cancer Center
Genentech
OSI Pharmaceuticals
Investigators
| Principal Investigator: | Hossein Borghaei, DO | Fox Chase Cancer Center |
More Information
No publications provided
| Responsible Party: | Hossein Borghaei, DO, Fox Chase Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00553800 History of Changes |
| Other Study ID Numbers: | FER-TH-007 |
| Study First Received: | November 5, 2007 |
| Last Updated: | June 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
Bevacizumab Erlotinib Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013