NSCLC: Study of Bevacizumab and Erlotinib in Patients With Advanced Non-small Cell Lung Cancer

• Sponsor: Fox Chase Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00553800
• Collaborator: Genentech, Inc. (Industry), OSI Pharmaceuticals (Industry)
• Enrollment: 32
• Locations: 7
• Arm: 1
• Actual Duration (Months): 46.9
• Patients Per Site: 4.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study will evaluate the combination of bevacizumab and erlotinib in elderly patients with advanced non-small cell lung cancer.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung	Drug: bevacizumab; Drug: Erlotinib	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Bevacizumab and Erlotinib in Elderly Patients With Advanced Non-Small Lung Cancer
• Actual Study Start Date: Jul 5, 2007
• Actual Primary Completion Date: Jan 12, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bevacizumab & Erlotinib bevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day	Drug: bevacizumab; Other Names: Other names: Avastin ; Drug: Erlotinib; Other Names: Other name: Tarceva

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) [3 years]

   Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	AtlantiCare Regional Medical Center	Galloway	New Jersey	United States	08205
2	Fox Chase Virtua Health Cancer Program at Memorial	Mount Holly	New Jersey	United States	08060
3	Paoli Hospital	Paoli	Pennsylvania	United States	19301
4	Abramson Cnacer Center, University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
5	Pennsylvania Oncology Hematology Associates	Philadelphia	Pennsylvania	United States	19106
6	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
7	Grand View Hospital	Sellersville	Pennsylvania	United States	18960

Sponsors and Collaborators

• Fox Chase Cancer Center
• Genentech, Inc.
• OSI Pharmaceuticals

Investigators

• Principal Investigator: Hossein Borghaei, DO, Fox Chase Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 1, 2012

More Information

Additional Information:

• Related Info

Publications

• Phase II study of bevacizumab and erlotinib in treatment-naïve elderly patients (older than age 65) with advanced non-small cell lung cancer (NSCLC). H. Borghaei, R. Mehra, M. M. Millenson, H. Tuttle, K. Ruth, A. J. Magdalinski, D. M. Mintzer, J. W. Lee, G. R. Simon, and C. J. Langer Journal of Clinical Oncology 2010 28:15_suppl, e18019-e18019

• Responsible Party: Fox Chase Cancer Center
• ClinicalTrials.gov Identifier: NCT00553800
• Other Study ID Numbers: FER-TH-007
• First Posted: Nov 6, 2007
• Last Update Posted: Jul 12, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung; Bevacizumab; Erlotinib Hydrochloride

Study Results

Participant Flow

Arm/Group Title	Bevacizumab & Erlotinib
Arm/Group Description	bevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day bevacizumab Erlotinib
Period Title: Overall Study
STARTED	32
COMPLETED	32
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Bevacizumab & Erlotinib
Arm/Group Description	bevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day bevacizumab Erlotinib
Overall Participants	32
Age, Customized (Count of Participants)
≤ 75 yrs	18 56.3%
> 75 yrs	14 43.8%
Sex: Female, Male (Count of Participants)
Female	17 53.1%
Male	15 46.9%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	26 81.3%
African-American	5 15.6%
Native American	1 3.1%
Region of Enrollment (participants) [Number]
United States	32 100%

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival (PFS)
Description	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bevacizumab & Erlotinib
Arm/Group Description	bevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day bevacizumab Erlotinib
Measure Participants	32
Median (95% Confidence Interval) [months]	6.6

Adverse Events

Time Frame	3 years
Arm/Group Title	Bevacizumab & Erlotinib
Arm/Group Description	bevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day bevacizumab Erlotinib
All Cause Mortality
	Bevacizumab & Erlotinib
	Affected / at Risk (%)	# Events
Total	17/32 (53.1%)
Serious Adverse Events
	Bevacizumab & Erlotinib
	Affected / at Risk (%)	# Events
Total	15/32 (46.9%)
Cardiac disorders
Hypoxia	1/32 (3.1%)
Gastrointestinal disorders
Constipation	1/32 (3.1%)
Diarrhea	2/32 (6.3%)
Bowel perforation	1/32 (3.1%)
General disorders
Pain	3/32 (9.4%)
Fatigue	1/32 (3.1%)
Metabolism and nutrition disorders
Dehydration	3/32 (9.4%)
FTT	1/32 (3.1%)
Anorexia	1/32 (3.1%)
Anemia	1/32 (3.1%)
Psychiatric disorders
Confusion	2/32 (6.3%)
Respiratory, thoracic and mediastinal disorders
Pneumonia	1/32 (3.1%)
Shortness of breath	2/32 (6.3%)
Dyspnea	1/32 (3.1%)
Other (Not Including Serious) Adverse Events
	Bevacizumab & Erlotinib
	Affected / at Risk (%)	# Events
Total	32/32 (100%)
Gastrointestinal disorders
Nausea	9/32 (28.1%)
Vomiting	6/32 (18.8%)
Diarrhea	12/32 (37.5%)
Constipation	10/32 (31.3%)
Anorexia	8/32 (25%)
General disorders
Fatigue	10/32 (31.3%)
Metabolism and nutrition disorders
Weight loss	7/32 (21.9%)
Nervous system disorders
Neuropathy	7/32 (21.9%)
Psychiatric disorders
Depression	7/32 (21.9%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	8/32 (25%)
Skin and subcutaneous tissue disorders
Rash	13/32 (40.6%)
Nail changes	3/32 (9.4%)
Dry cracked skin	8/32 (25%)
Fissures	2/32 (6.3%)
Incr. hair growth	3/32 (9.4%)
Alopecia	5/32 (15.6%)
Vascular disorders
Hypertension	9/32 (28.1%)
Deep vein thrmbosis	1/32 (3.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.