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A Randomized Phase II Trial of Pemetrexed/Gemcitabine/Bevacizumab or Pemetrexed/Carboplatin/Bevacizumab in the First-Line Treatment of Elderly Patients With Advanced Non-Small Cell Lung Cancer


Phase 2
70 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Randomized Phase II Trial of Pemetrexed/Gemcitabine/Bevacizumab or Pemetrexed/Carboplatin/Bevacizumab in the First-Line Treatment of Elderly Patients With Advanced Non-Small Cell Lung Cancer


Patients in this study will be assigned to one of 2 treatment groups. The selection of the
treatment groups will be done randomly by a computer.

The first group, Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes
followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2
by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each
treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen
patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following
that they can receive bevacizumab alone once every 2 weeks as long as their disease does not
worsen.

The second group, Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes
followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by
carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each
treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen
patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following
that they can receive bevacizumab alone once every 3 weeks as long as their disease does not
worsen.

In both regimens vitamin B12 injections and Folic Acid pills will be given to reduce the
occurrence of side effects from the treatment.

Each patient's disease will be evaluated at intervals by the proper scans or X-rays to see
how well the cancer is responding to the treatment.


Inclusion Criteria:



- Histologically confirmed non-small cell bronchogenic carcinoma, (adenocarcinoma, or
large cell carcinoma)

- Patients who have newly diagnosed unresectable stage III or stage IV disease are
eligible.

- Must be at least 70 years of age

- Must have measurable disease by CT scan

- Must be able to be up and about and care for themselves

- May not have received prior treatment for stage III or IV disease

- Must have adequate white and red blood cells and platelets.

- Must be able to take Vitamin B12, Folic Acid and dexamethasone as stated in the study

- Must be able to understand the nature of this study and give written informed consent

- Adequate liver and kidney function

Exclusion Criteria:

- Past or current history of cancer with the exception of treated non- melanoma skin
cancer or carcinoma in-situ of the cervix, or other cancers cured by local therapy
alone and have been disease free for five years

- Female patients who are pregnant or are lactating are ineligible

- History of unstable angina or myocardial infarction within 6 months prior to
beginning bevacizumab

- Brain metastasis - cancer that has spread to the brain

- Major surgical procedure, open biopsy, or significant traumatic injury within 6 weeks
of beginning bevacizumab or anticipation of need for major surgical procedure during
the course of the study

- Full-dose oral or by vein anticoagulation or receiving anti-clotting therapy within
10 days of starting treatment

- Serious nonhealing wound, ulcer, or bone fracture

- Bleeding or clotting disorders

- Uncontrolled high blood pressure or serious heart arrhythmia requiring medication

- History of abdominal fistula, gastrointestinal perforation, or intra- abdominal
abscess within 6 months prior to beginning bevacizumab

- Chronic non-steroidal anti-inflammatory use is not allowed on study

- History of stroke or TIAs within the last 6 months

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease

Outcome Description:

Defined as the interval between the date of treatment initiation and the date of progressive disease

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

David R Spigel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI LUN 139

NCT ID:

NCT00456261

Start Date:

March 2007

Completion Date:

September 2012

Related Keywords:

  • Lung Cancer
  • Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
Florida Cancer SpecialistsFort Myers, Florida  33901
Northeast Georgia Medical CenterGainesville, Georgia  30501
Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Consultants in Blood Disorders and CancerLouisville, Kentucky  40207
Methodist Cancer CenterOmaha, Nebraska  68114
Cancer Care of Western North CarolinaAsheville, North Carolina  28801
Mercy HospitalPortland, Maine  04101
Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Tennessee Oncology, PLLCClarksville, Tennessee  37043
Wellstar Cancer ResearchMarietta, Georgia  30060
Oncology Hematology CareCincinnati, Ohio  45242
Watson Clinic Center for Cancer Care and ResearchLakeland, Florida  33805
Graves-Gilbert ClinicBowling Green, Kentucky  42101
Providence Medical GroupTerre Haute, Indiana  47802
Chattanooga Oncology Hematology AssociatesChattanooga, Tennessee  37404
Associates in Hematology OncologyChattanooga, Tennessee  37404
NEA Baptist ClinicJonesboro, Arkansas  72401