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A Study to Evaluate Bevacizumab and Chemotherapy or Tarceva in Treating Recurrent or Refractory NSCLC (Non-Small Cell Lung Cancer)

Primary Purpose

Non-Small-Cell Lung Carcinoma, Neoplasm Recurrence, Local

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Avastin (bevacizumab)
Tarceva (erlotinib HCl)
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small-Cell Lung Carcinoma focused on measuring Recurrent or refractory non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed written informed consent Histologically or cytologically proven Stage IIIb with pleural effusion, or Stage IV, recurrent non-squamous NSCLC that is recurrent and unresectable Progression after one line of platinum-based chemotherapy (patients who have received prior docetaxel treatment are eligible to participate if there are no contraindications for pemetrexed treatment) Progression after previous adjuvant chemotherapy, if therapy was completed >= 6 months prior to randomization and the patient has received one line of therapy for recurrent disease (Optional) Availability of archival diagnostic tissue (paraffin tissue block or 2-10 unstained slides representative of the patient's primary cancer) ECOG performance status of 0, 1, or 2 Life expectancy >= 3 months Measurable disease in accordance with RECIST Age >= 18 years Use of an acceptable means of contraception (potentially fertile men and women) or documentation of infertility Exclusion Criteria: More than 30 days of prior treatment with an investigational or marketed agent that acts by EGFR inhibition (those with 30 or fewer days on an EGFR inhibitor without disease progression are eligible for enrollment) Treatment with an investigational or marketed agent that acts by anti-angiogenic mechanisms Previous treatment with more than one platinum-based chemotherapy Chemotherapy or radiotherapy within 28 days prior to randomization History of hemoptysis (&gt; 1 teaspoon) or presence of a cavitary lesion Clinical history of Grade &gt; 2 hematemesis within 6 months or Grade 1 hematemesis within 28 days prior to randomization History of serious systemic disease, including myocardial infarction within the last 6 months, uncontrolled hypertension (blood pressure &gt; 150/100 mmHg on medication), unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or Grade II or greater peripheral vascular disease History or clinical evidence of CNS or brain metastases or CNS bleeding History or clinical evidence of hemorrhagic or thrombotic stroke within the 6 months prior to randomization Centrally located lesions and lesions that abut major blood vessels Ongoing treatment with full-dose warfarin (or its equivalent) or heparin (or its equivalent; e.g., Lovenox(R)) In-patient surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization Minor surgical procedure, fine needle aspirations, or core biopsy within 7 days prior to randomization Anticipation of need for a major surgical procedure during the course of the study Serious, non-healing wound, ulcer, or bone fracture Inability to take oral medication or requirement for IV alimentation or total parenteral nutrition with lipids, or prior surgical procedures affecting absorption Any of the following abnormal hematologic values (within 1 week prior to randomization): ANC <= 1,500 cells/uL; platelet count <= 100,000 cells/uL; Hemoglobin <= 9.0 g/dL; International normalized ratio (INR) &gt; 1.5 x upper limit of normal (ULN) For patients who will receive docetaxel, any of the following abnormal liver function tests (within 1 week prior to randomization): Serum bilirubin greater than ULN; Albumin <= 2.5 g/dL; Serum ALT >= 1.5 x ULN; Serum AST >= 1.5 x ULN; Alkaline phosphatase >= 2.5 x ULN Other baseline laboratory values: Serum creatinine &gt; 2.0 x ULN; Uncontrolled hypercalcemia ( &gt; 11.5 mg/dL); Urinary protein/creatinine ratio >= 1 (spot urine) or clinically significant impairment of renal function; Estimated creatinine clearance &lt; 45 mL/min (for patients who will receive pemetrexed) Any active systemic bacterial, fungal, or viral infection, including known hepatitis C and HIV Pregnant or breast-feeding Presence of another cancer within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix or non-melanomatous skin cancer Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient's understanding of the Informed Consent Form

Sites / Locations

  • Comprehensive Blood and Cancer Center (TORI)
  • Bay Area Cancer Research Group
  • Virginia K. Crosson Cancer Center (TORI)
  • California Cancer Center, Inc
  • Wilshire Oncology Medical Group (TORI)
  • Pacific Shores Medical Group (TORI)
  • UCLA Medical Center PVUB 3360
  • Central Hematology Oncology Medical Group (TORI)
  • North Valley Hematology/Oncology Medical Group (TORI)
  • Ventura County Hematology-Oncology Specialists (TORI)
  • Cancer Care Associates Medical Group (TORI)
  • UC Davis Cancer Center
  • Kaiser Permanente/ San Diego
  • Sansum Santa Barbara Medical Foundation Clinic (TORI)
  • Santa Barbara Hematology Oncology Medical Group, Inc (TORI)
  • Kaiser Permanente Northern CA
  • San Diego Cancer Center Medical Group (TORI)
  • Comprehensive Cancer Care Specialist at Boca Raton
  • Florida Cancer Specialists
  • The Florida Cancer Institute(TORI)
  • MD Anderson Cancer Ctr- Orlando
  • Hematology and Oncology of Northeast Georgia, PC (TORI)
  • Medical Oncology Associates, PC (TORI)
  • Suburban Hematology-Oncology Associates (TORI)
  • WellStar Cancer Research Office
  • Atlanta Cancer Care (TORI)
  • Rush-Presbyteriam
  • University of Chicago
  • Loyola Univ. Medical Center
  • Hematology Oncology Consultants
  • Oncoloy Hematology Associates of Central Illinois, PC (TORI)
  • Norton Healthcare Louisville Oncology
  • Ochsner Cancer Inst.
  • Maine Center for Cancer Medicine and Blood Disorders
  • Methodist Cancer Center-Oncology Research
  • Comprehensive Cancer Centers of Nevada (TORI)
  • Summit Medical Group Overlook Oncology Center
  • Cancer Research of Long Island
  • Northwestern Carolina Oncology and Hematology
  • Mid Dakota Clinic
  • Earle A. Chiles Research Institute
  • Kaiser Permanente Northwest Region
  • Univ. of Pittsburgh Cancer Center Inst.
  • University of Tenn. Cancer Ins
  • The West Cancer Clinic
  • M.D. Anderson
  • Virginia Mason Medical Center
  • Internal Medicine Associates of Yakima

Outcomes

Primary Outcome Measures

To evaluate the safety and preliminary efficacy of combining bevacizumab with chemotherapy or Tarceva relative to chemotherapy alone on patients with previously treated advanced non-small cell lung cancer.

Secondary Outcome Measures

Full Information

First Posted
November 1, 2004
Last Updated
January 23, 2008
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00095225
Brief Title
A Study to Evaluate Bevacizumab and Chemotherapy or Tarceva in Treating Recurrent or Refractory NSCLC (Non-Small Cell Lung Cancer)
Official Title
A Phase II, Multicenter, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy (Docetaxel or Pemetrexed) or Tarceva (Erlotinib) Compared With Chemotherapy (Docetaxel or Pemetrexed) Alone for Treatment of Recurrent or Refractory Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Genentech, Inc.

4. Oversight

5. Study Description

Brief Summary
This Phase II, multicenter, randomized trial is designed to make preliminary evaluations of the efficacy of combining bevacizumab with chemotherapy (docetaxel or pemetrexed) or Tarceva relative to chemotherapy (docetaxel or pemetrexed) alone in patients with previously treated advanced NSCLC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small-Cell Lung Carcinoma, Neoplasm Recurrence, Local
Keywords
Recurrent or refractory non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Avastin (bevacizumab)
Intervention Type
Drug
Intervention Name(s)
Tarceva (erlotinib HCl)
Primary Outcome Measure Information:
Title
To evaluate the safety and preliminary efficacy of combining bevacizumab with chemotherapy or Tarceva relative to chemotherapy alone on patients with previously treated advanced non-small cell lung cancer.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed written informed consent Histologically or cytologically proven Stage IIIb with pleural effusion, or Stage IV, recurrent non-squamous NSCLC that is recurrent and unresectable Progression after one line of platinum-based chemotherapy (patients who have received prior docetaxel treatment are eligible to participate if there are no contraindications for pemetrexed treatment) Progression after previous adjuvant chemotherapy, if therapy was completed >= 6 months prior to randomization and the patient has received one line of therapy for recurrent disease (Optional) Availability of archival diagnostic tissue (paraffin tissue block or 2-10 unstained slides representative of the patient's primary cancer) ECOG performance status of 0, 1, or 2 Life expectancy >= 3 months Measurable disease in accordance with RECIST Age >= 18 years Use of an acceptable means of contraception (potentially fertile men and women) or documentation of infertility Exclusion Criteria: More than 30 days of prior treatment with an investigational or marketed agent that acts by EGFR inhibition (those with 30 or fewer days on an EGFR inhibitor without disease progression are eligible for enrollment) Treatment with an investigational or marketed agent that acts by anti-angiogenic mechanisms Previous treatment with more than one platinum-based chemotherapy Chemotherapy or radiotherapy within 28 days prior to randomization History of hemoptysis (&gt; 1 teaspoon) or presence of a cavitary lesion Clinical history of Grade &gt; 2 hematemesis within 6 months or Grade 1 hematemesis within 28 days prior to randomization History of serious systemic disease, including myocardial infarction within the last 6 months, uncontrolled hypertension (blood pressure &gt; 150/100 mmHg on medication), unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or Grade II or greater peripheral vascular disease History or clinical evidence of CNS or brain metastases or CNS bleeding History or clinical evidence of hemorrhagic or thrombotic stroke within the 6 months prior to randomization Centrally located lesions and lesions that abut major blood vessels Ongoing treatment with full-dose warfarin (or its equivalent) or heparin (or its equivalent; e.g., Lovenox(R)) In-patient surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization Minor surgical procedure, fine needle aspirations, or core biopsy within 7 days prior to randomization Anticipation of need for a major surgical procedure during the course of the study Serious, non-healing wound, ulcer, or bone fracture Inability to take oral medication or requirement for IV alimentation or total parenteral nutrition with lipids, or prior surgical procedures affecting absorption Any of the following abnormal hematologic values (within 1 week prior to randomization): ANC <= 1,500 cells/uL; platelet count <= 100,000 cells/uL; Hemoglobin <= 9.0 g/dL; International normalized ratio (INR) &gt; 1.5 x upper limit of normal (ULN) For patients who will receive docetaxel, any of the following abnormal liver function tests (within 1 week prior to randomization): Serum bilirubin greater than ULN; Albumin <= 2.5 g/dL; Serum ALT >= 1.5 x ULN; Serum AST >= 1.5 x ULN; Alkaline phosphatase >= 2.5 x ULN Other baseline laboratory values: Serum creatinine &gt; 2.0 x ULN; Uncontrolled hypercalcemia ( &gt; 11.5 mg/dL); Urinary protein/creatinine ratio >= 1 (spot urine) or clinically significant impairment of renal function; Estimated creatinine clearance &lt; 45 mL/min (for patients who will receive pemetrexed) Any active systemic bacterial, fungal, or viral infection, including known hepatitis C and HIV Pregnant or breast-feeding Presence of another cancer within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix or non-melanomatous skin cancer Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient's understanding of the Informed Consent Form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vince O'Neill, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Comprehensive Blood and Cancer Center (TORI)
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Bay Area Cancer Research Group
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Virginia K. Crosson Cancer Center (TORI)
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
California Cancer Center, Inc
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Wilshire Oncology Medical Group (TORI)
City
Laverne
State/Province
California
ZIP/Postal Code
91750
Country
United States
Facility Name
Pacific Shores Medical Group (TORI)
City
Long Beach
State/Province
California
ZIP/Postal Code
90813-3244
Country
United States
Facility Name
UCLA Medical Center PVUB 3360
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Central Hematology Oncology Medical Group (TORI)
City
Monterey Park
State/Province
California
ZIP/Postal Code
91754
Country
United States
Facility Name
North Valley Hematology/Oncology Medical Group (TORI)
City
Northridge
State/Province
California
ZIP/Postal Code
91328
Country
United States
Facility Name
Ventura County Hematology-Oncology Specialists (TORI)
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Cancer Care Associates Medical Group (TORI)
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
UC Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente/ San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Sansum Santa Barbara Medical Foundation Clinic (TORI)
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Santa Barbara Hematology Oncology Medical Group, Inc (TORI)
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Kaiser Permanente Northern CA
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
San Diego Cancer Center Medical Group (TORI)
City
Vista
State/Province
California
ZIP/Postal Code
92081
Country
United States
Facility Name
Comprehensive Cancer Care Specialist at Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
The Florida Cancer Institute(TORI)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
MD Anderson Cancer Ctr- Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Hematology and Oncology of Northeast Georgia, PC (TORI)
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Medical Oncology Associates, PC (TORI)
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Suburban Hematology-Oncology Associates (TORI)
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
WellStar Cancer Research Office
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Atlanta Cancer Care (TORI)
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Rush-Presbyteriam
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Loyola Univ. Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Hematology Oncology Consultants
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
Oncoloy Hematology Associates of Central Illinois, PC (TORI)
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Norton Healthcare Louisville Oncology
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Ochsner Cancer Inst.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Maine Center for Cancer Medicine and Blood Disorders
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Methodist Cancer Center-Oncology Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada (TORI)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Summit Medical Group Overlook Oncology Center
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Cancer Research of Long Island
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Northwestern Carolina Oncology and Hematology
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28603
Country
United States
Facility Name
Mid Dakota Clinic
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Earle A. Chiles Research Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Kaiser Permanente Northwest Region
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Univ. of Pittsburgh Cancer Center Inst.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
University of Tenn. Cancer Ins
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
The West Cancer Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
M.D. Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Internal Medicine Associates of Yakima
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate Bevacizumab and Chemotherapy or Tarceva in Treating Recurrent or Refractory NSCLC (Non-Small Cell Lung Cancer)

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