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Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00402883
Recruitment Status : Terminated (Terminated due to bevacizumab and chemoradiotherapy toxicity)
First Posted : November 22, 2006
Results First Posted : January 13, 2014
Last Update Posted : January 13, 2014
Sponsor:
Collaborators:
Genentech, Inc.
Eli Lilly and Company
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Tracking Information
First Submitted Date  ICMJE November 21, 2006
First Posted Date  ICMJE November 22, 2006
Results First Submitted Date  ICMJE August 15, 2013
Results First Posted Date  ICMJE January 13, 2014
Last Update Posted Date January 13, 2014
Study Start Date  ICMJE November 2006
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2008)
Time to Progression [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2006)
  • Safety (toxicity)
  • Time to progression of disease
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2008)
  • To Evaluate the Objective Response Rates [ Time Frame: 18 months ]
  • Overall Survival [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2006)
  • To Evaluate the Objective Response Rates
  • Overall Survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer
Official Title  ICMJE A Phase II Study of Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer
Brief Summary The purpose of this study is to see if this combination of chemotherapy plus radiation therapy and immunotherapy (with bevacizumab) expands treatment options for patients with non-small cell lung cancer.
Detailed Description

The patients on this study will receive treatment in 3 stages of therapy.

The first stage is Induction Therapy. This therapy is 7 weeks long. Patients will receive bevacizumab followed by pemetrexed followed by carboplatin all by vein once a week in weeks 1 and 4. During Induction patients will also receive radiation therapy daily, Monday through Friday, for 7 weeks (weeks 1-7). This is followed by 2 weeks of rest. During this rest period patients will have scans done to see how their disease has responded to treatment.

The next stage of treatment is Consolidation Therapy. This stage is 10 weeks long. Patients will receive bevacizumab followed by pemetrexed followed by carboplatin all by vein once a week in weeks 10, 13 and 16. This is followed by 3 weeks rest. During week 19 patients will have scans to see how their disease has responded to treatment.

The last stage of treatment is Maintenance Therapy. Patients will receive bevacizumab alone by vein every 3 weeks. Treatment will be given every three weeks for up to 9 treatments. (week 45)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Drug: Bevacizumab
    15mg/kg week 1, 4, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, and 49.
    Other Name: Avastin
  • Drug: Pemetrexed
    500mg/m2 week 1, 4, 16, 19 and 22.
    Other Name: Alimta
  • Procedure: Radiotherapy
    1.8 Gy single daily fractions(Monday-Friday), to total dose 61.2 Gy (7 weeks)
    Other Name: RT
  • Other: Folic Acid
    350 to 1,000 ug or equivalent supplementation administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinues study therapy.
  • Other: vitamin B12
    1,000ug administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinues therapy.
  • Drug: carboplatin
    AUC=5 administered intravenously weeks 1 and 4.
Study Arms  ICMJE Experimental: Intervention
Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
Interventions:
  • Drug: Bevacizumab
  • Drug: Pemetrexed
  • Procedure: Radiotherapy
  • Other: Folic Acid
  • Other: vitamin B12
  • Drug: carboplatin
Publications * Spigel DR, Hainsworth JD, Yardley DA, Raefsky E, Patton J, Peacock N, Farley C, Burris HA 3rd, Greco FA. Tracheoesophageal fistula formation in patients with lung cancer treated with chemoradiation and bevacizumab. J Clin Oncol. 2010 Jan 1;28(1):43-8. doi: 10.1200/JCO.2009.24.7353. Epub 2009 Nov 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 27, 2013)
5
Original Enrollment  ICMJE
 (submitted: November 21, 2006)
50
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinically confirmed non-small cell lung cancer stage IIIA and selected stage IIIB
  • Measurable or evaluable disease
  • Be up and about and able to care for self
  • Adequate kidney, liver and bone marrow function
  • No prior treatment for this disease
  • Must be able to give written informed consent
  • Must be able to take folic acid, vitamin B12 and dexamethasone as described in the protocol
  • Age 18 years or older

Exclusion Criteria:

  • Stage IV or IIIB patients with pleural or pericardial effusions
  • Stage IIIB disease with contralateral mediastinal nodes greater than 4cm
  • Squamous cell predominant tumors
  • Pregnant or lactating women
  • Patients with active infections
  • History of another cancer within the last 5 years with the exception of skin cancer or cervical carcinoma in situ
  • History of stroke, transient ischemic attacks, or acute MI within the past 6 months or any other serious cardiovascular disease
  • Symptoms of peripheral vascular disease
  • History of neurological disease
  • Recent history of blood in the sputum or vomitus
  • Non-healing wounds, ulcer or long bone fractures
  • History of bleeding problems or coagulation problems
  • History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 6 months
  • History of uncontrolled hypertension
  • Chronic use of non-steroidal anti-inflammatory medication not allowed on this study

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00402883
Other Study ID Numbers  ICMJE SCRI LUN 134
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SCRI Development Innovations, LLC
Study Sponsor  ICMJE SCRI Development Innovations, LLC
Collaborators  ICMJE
  • Genentech, Inc.
  • Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: David Spigel, MD SCRI Development Innovations, LLC
PRS Account SCRI Development Innovations, LLC
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP