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A Phase II Study of Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer


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

Thank you

Trial Information

A Phase II Study of Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer


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 premetrexed 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 premetrexed 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)


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to progression

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

David Spigel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI LUN 134

NCT ID:

NCT00402883

Start Date:

November 2006

Completion Date:

January 2009

Related Keywords:

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

Name

Location

Consultants in Blood Disorders and CancerLouisville, Kentucky  40207
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
Gainsville Hematology Oncology AssociatesGainesville, Florida  32605
Associates in Hematology OncologyChattanooga, Tennessee  37404