AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 2NCT00621049

Carboplatin, Docetaxel, Bevacizumab, and Erlotinib Versus Chemotherapy Alone in Resected NSCLC

A Phase 2 study testing Docetaxel/Carboplatin/Bevacizumab/Erlotinib and Docetaxel/Carboplatin in people with Non-Small Cell Lung Cancer, run by SCRI Development Innovations, LLC at 26 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

Multicenter randomized phase II trial to examine the safety and efficacy of carboplatin, docetaxel, bevacizumab followed by maintenance bevacizumab and erlotinib in patients with completely resected stage IB, II, and select III NSCLC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Docetaxel/Carboplatin/Bevacizumab/Erlotinib and Docetaxel/Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
26 sitesUnited States
Study dates
Dec 2007to Feb 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients must have histologically-confirmed non-small cell lung cancer (adenocarcinoma, squamous, large cell and undifferentiated). Mixed small cell and non-small histologies are excluded.
  • Patients with completely resected (R0) stage IB, II, and select III NSCLC. The following stages are eligible:
  • IB T2 N0 IIA T1 N1 IIB T2 N1 IIB T3 N0 IIIA T3 N1
  • Bronchioalveolar carcinoma that presents as a single, solitary discrete nodule or mass may be included
  • Patients determined to have N2 disease, that was not apparent radiologically preoperatively (and completely resected) can be included.
  • Complete surgical resection defined as the appropriate pulmonary parenchymal resection including lobectomy, bilobectomy, sleeve lobectomy, and pneumonectomy with histologically confirmed negative bronchial margins. Patients treated by segmentectomy or wedge resection are not eligible for this study. Additionally all patients must have had either a mediastinal node dissection or at least, sampling of 2 mediastinal nodal stations (levels 4,7,and 9 for right-sided tumors, and levels 5,6,7, and 9 for left-sided tumors are suggested.)
Show all 15Show fewer
  • No evidence of metastatic disease
  • ANC >= 1500, platelets >= 100,000 and hemoglobin >= 10.0.
  • Total bilirubin <= ULN. AST and ALT and alkaline phosphatase must be WNL
  • Serum creatinine <= 1.5mg/dl (If greater than 1.5, the creatinine clearance, calculated according to the Cockroft-Gault formula, must be >= 50ml/min).
  • Patients may have had no previous chemotherapy, radiation therapy, angiogenesis inhibitor, or tyrosine kinase inhibitor for non-small cell lung cancer.
  • Patients must be able to understand the nature of this study and give written informed consent.
  • Age >= 18 years
  • Ability to start treatment between 8 and 12 weeks following surgery.
  • Ability to take oral medication.

Who cannot join

  • Patients with preoperative radiologic evidence of N2 disease by either PET or CT scan (i.e. radiological evidence of metastasis to ipsilateral mediastinal and subcarinal nodes) that is confirmed as N2 disease histologically are excluded. - PLEASE SEE EXCEPTION in section 3.1.2 of protocol
  • Mixed small cell and non-small cell histologies
  • Pulmonary carcinoid tumors
  • Positive bronchial margins
  • History of prior malignancy within 5 years with the exception of skin cancer or cervical carcinoma in situ.
  • Women who are pregnant (positive pregnancy test) or breast-feeding. Subjects of childbearing potential or with partners of childbearing potential (women and men) must use effective birth control measures during treatment.
Show all 31Show fewer
  • Treatment with a non-approved or investigational drug within 30 days before day 1 of trial treatment.
  • Patients with seizures not controlled with standard medical therapy.
  • Patients with active infection requiring parenteral antibiotics
  • Patients who have had major surgical procedure, open biopsy, or significant traumatic injury within 8 weeks of beginning study treatment or anticipation of need for major surgical procedure during the course of the study
  • Fine needle aspiration, core biopsy or other minor surgical procedure (excluding placement of a vascular access device) within 7 days of beginning study treatment.
  • Patients receiving thrombolytic therapy within 10 days of starting study treatment are also ineligible. Patients may receive prophylactic anticoagulation therapy, 1 mg coumadin daily for port clot prophylaxis.
  • Patients with proteinuria at screening as demonstrated by either:
  • Urine protein creatinine (UPC) ratio >= 1.0 at screening OR
  • Urine dipstick for proteinuria >= 2+ (patients discovered to have >= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate >= 1 g of protein in 24hours to be eligible).
  • Patients with serious nonhealing wound, ulcer, or bone fracture.
  • Patients with evidence of bleeding diathesis or coagulopathy.
  • Patients with history of hemoptysis defined as bright red blood of ½ teaspoon or more per episode) within 8 weeks prior to study treatment.
  • History of myocardial infarction or unstable angina within 6 months of beginning study treatment.
  • Inadequately controlled hypertension (defined as systolic blood pressure > 150 and /or diastolic blood pressure > 100 mmHg on antihypertensive medications).
  • New York Heart Association (NYHA) grade II or greater CHF.
  • Serious cardiac arrhythmia requiring medication.
  • Symptomatic peripheral vascular disease.
  • History of stroke or transient ischemic attack within 6 months prior to beginning bevacizumab.
  • Any prior history of hypertensive crisis or hypertensive encephalopathy.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning study treatment.
  • ECOG Performance status > 1.
  • Peripheral neuropathy> grade 1.
  • Known hypersensitivity to any component of study drugs including platinum or to drugs formulated with polysorbate 80.
  • Impaired oral absorption.
  • Inability to comply with study and/or follow-up procedures.

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

United States26 sites

  • New Mexico Oncology Hematology Consultants

    Albuquerque, New Mexico, 87109

  • Hematology Oncology Life Center

    Alexandria, Louisiana, 71301

  • Northeast Alabama Medical Center

    Anniston, Alabama, 36207

  • Cancer Care of Western North Carolina

    Asheville, North Carolina, 28801

  • Medical Oncology Associates of Augusta

    Augusta, Georgia, 30901

  • Hematology Oncology Clinic, LLP

    Baton Rouge, Louisiana, 70806

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Associates in Hematology Oncology

    Chattanooga, Tennessee, 37404

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • St. Louis Cancer Care

    Chesterfield, Missouri, 63017

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Jackson Oncology Associates

    Jackson, Mississippi, 39202

  • Northeast Arkansas Clinic

    Jonesboro, Arkansas, 72401

  • Baptist Hospital East

    Louisville, Kentucky, 40207

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • Wellstar Cancer Research

    Marietta, Georgia, 30060

  • Hematology Oncology Associates of Northern NJ

    Morristown, New Jersey, 07960

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37023

  • Peninsula Cancer Institute

    Newport News, Virginia, 23601

  • Nebraska Methodist Cancer Center

    Omaha, Nebraska, 68114

  • Portsmouth Regional Hospital

    Portsmouth, New Hampshire, 03801

  • Gulfcoast Oncology Associates

    St. Petersburg, Florida, 33705

  • Providence Medical Group

    Terre Haute, Indiana, 47802

  • RHHP/Hope Cancer Center

    Terre Haute, Indiana, 47802

Other trials in United States

About this study

Official title: Randomized Phase II Trial of Adjuvant Carboplatin, Docetaxel, Bevacizumab, and Erlotinib Versus Chemotherapy Alone in Patients With Resected Non-Small Cell Lung Cancer

Multicenter randomized phase II trial to examine the safety and efficacy of carboplatin, docetaxel, bevacizumab followed by maintenance bevacizumab and erlotinib in patients with completely resected stage IB, II, and select III NSCLC.

Being tested
Docetaxel/Carboplatin/Bevacizumab/Erlotinib, Docetaxel/Carboplatin
Keywords
Non-Small Cell Lung Cancer, Resected, Carboplatin, Docetaxel, Bevacizumab, Erlotinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Docetaxel/Carboplatin/Bevacizumab/ErlotinibDrug

    Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1

    Docetaxel should be administered before carboplatin.

    After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:

    Maintenance Treatment for patients in Cohort A:

    Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily

    Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity.

  • Docetaxel/CarboplatinDrug

    Adjuvant Treatment Cohort B:

    Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1

    Docetaxel should be administered before carboplatin.

    Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment.

Study groups in NCT00621049
Study groupRoleWhat they receive
Docetaxel/Carboplatin/Bevacizumab/ErlotinibExperimentalNot described
Receives: Drug: Docetaxel/Carboplatin/Bevacizumab/Erlotinib
Docetaxel and CarboplatinActive comparatorNot described
Receives: Drug: Docetaxel/Carboplatin

What is being measured

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

  1. Disease-free Survival

    The length of time, in months, that patients were alive from the end of their treatment without any signs or symptoms of their disease.

    Measured: 1 year

Secondary outcomes (3)

  1. Safety

    Adverse Events occuring in >15% of patients

    Measured: 2 years

  2. 2-year Survival

    Proportion of patients known to still be alive 2 years after coming on study

    Measured: 24 months

  3. Overall Survival (OS)

    The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

    Measured: 18 months

Timeline

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

  1. First posted22 Feb 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionJul 2013
  4. Study completionFeb 2014

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
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00621049
Sponsor's protocol ID
SCRI LUN 142
Other IDs
US_IST_12218, AVF3923s
Status last verified
May 2015
First submitted
26 Dec 2007
Last updated
8 Jun 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel/Carboplatin/Bevacizumab/Erlotinib and Docetaxel/Carboplatin in people with Non-Small Cell Lung Cancer, run by SCRI Development Innovations, LLC at 26 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 15 inclusion and 31 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 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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?

Yes. Results are posted in the registry (first posted 14 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Disease-free Survival (time frame: 1 year). 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 NCT00621049.

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 8 Jun 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in