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Non-Small-Cell Lung CarcinomaPhase 2NCT00095225

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

A Phase 2 study testing Avastin (bevacizumab) and Tarceva (erlotinib HCl) in people with Non-Small-Cell Lung Carcinoma and Neoplasm Recurrence, Local, run by Genentech, Inc. at 48 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Avastin (bevacizumab) and Tarceva (erlotinib HCl)
How many people
122 participants
Where
48 sitesUnited States
Study dates
Jul 2004to Nov 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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 (\> 1 teaspoon) or presence of a cavitary lesion
  • Clinical history of Grade \> 2 hematemesis within 6 months or Grade 1 hematemesis within 28 days prior to randomization
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  • History of serious systemic disease, including myocardial infarction within the last 6 months, uncontrolled hypertension (blood pressure \> 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

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

United States48 sites

  • Hematology and Oncology of Northeast Georgia, PC (TORI)

    Athens, Georgia, 30607

  • Medical Oncology Associates, PC (TORI)

    Augusta, Georgia, 30901

  • Comprehensive Blood and Cancer Center (TORI)

    Bakersfield, California, 93309

  • Mid Dakota Clinic

    Bismarck, North Dakota, 58501

  • Comprehensive Cancer Care Specialist at Boca Raton

    Boca Raton, Florida, 33428

  • Rush-Presbyteriam

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • Bay Area Cancer Research Group

    Concord, California, 94520

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Virginia K. Crosson Cancer Center (TORI)

    Fullerton, California, 92835

  • Cancer Research of Long Island

    Great Neck, New York, 11023

  • California Cancer Center, Inc

    Greenbrae, California, 94904

  • Northwestern Carolina Oncology and Hematology

    Hickory, North Carolina, 28603

  • M.D. Anderson

    Houston, Texas, 77030

  • Comprehensive Cancer Centers of Nevada (TORI)

    Las Vegas, Nevada, 89109

  • Wilshire Oncology Medical Group (TORI)

    Laverne, California, 91750

  • Suburban Hematology-Oncology Associates (TORI)

    Lawrenceville, Georgia, 30045

  • Pacific Shores Medical Group (TORI)

    Long Beach, California, 90813-3244

  • UCLA Medical Center PVUB 3360

    Los Angeles, California, 90095

  • Norton Healthcare Louisville Oncology

    Louisville, Kentucky, 40202

  • WellStar Cancer Research Office

    Marietta, Georgia, 30060

  • Loyola Univ. Medical Center

    Maywood, Illinois, 60153

  • University of Tenn. Cancer Ins

    Memphis, Tennessee, 38104

  • The West Cancer Clinic

    Memphis, Tennessee, 38120

  • Central Hematology Oncology Medical Group (TORI)

    Monterey Park, California, 91754

  • Hematology Oncology Consultants

    Naperville, Illinois, 60540

  • Ochsner Cancer Inst.

    New Orleans, Louisiana, 70121

  • North Valley Hematology/Oncology Medical Group (TORI)

    Northridge, California, 91328

  • Methodist Cancer Center-Oncology Research

    Omaha, Nebraska, 68114

  • The Florida Cancer Institute(TORI)

    Orlando, Florida, 32804

  • MD Anderson Cancer Ctr- Orlando

    Orlando, Florida, 32806

  • Ventura County Hematology-Oncology Specialists (TORI)

    Oxnard, California, 93030

  • Oncoloy Hematology Associates of Central Illinois, PC (TORI)

    Peoria, Illinois, 61615

  • Univ. of Pittsburgh Cancer Center Inst.

    Pittsburgh, Pennsylvania, 15232

  • Earle A. Chiles Research Institute

    Portland, Oregon, 97213

  • Kaiser Permanente Northwest Region

    Portland, Oregon, 97227

  • Cancer Care Associates Medical Group (TORI)

    Redondo Beach, California, 90277

  • Atlanta Cancer Care (TORI)

    Roswell, Georgia, 30076

  • UC Davis Cancer Center

    Sacramento, California, 95817

  • Kaiser Permanente/ San Diego

    San Diego, California, 92120

  • Sansum Santa Barbara Medical Foundation Clinic (TORI)

    Santa Barbara, California, 93105

  • Santa Barbara Hematology Oncology Medical Group, Inc (TORI)

    Santa Barbara, California, 93105

  • Maine Center for Cancer Medicine and Blood Disorders

    Scarborough, Maine, 04074

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Summit Medical Group Overlook Oncology Center

    Summit, New Jersey, 07901

  • Kaiser Permanente Northern CA

    Vallejo, California, 94589

  • San Diego Cancer Center Medical Group (TORI)

    Vista, California, 92081

  • Internal Medicine Associates of Yakima

    Yakima, Washington, 98902

Other trials in United States

About this study

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

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.

Being tested
Avastin (bevacizumab), Tarceva (erlotinib HCl)
Keywords
Recurrent or refractory non-small cell lung cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasm Recurrence, Local, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Avastin (bevacizumab)Drug

  • Tarceva (erlotinib HCl)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2004 (estimated)
  2. Study startJul 2004
  3. Study completionNov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00095225
Sponsor's protocol ID
OSI2950g
Status last verified
Jan 2008
First submitted
1 Nov 2004
Last updated
29 Jan 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avastin (bevacizumab) and Tarceva (erlotinib HCl) in people with Non-Small-Cell Lung Carcinoma and Neoplasm Recurrence, Local, run by Genentech, Inc. at 48 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00095225.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2008.

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