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A Phase II Evaluation of Avastin in Combination With Docetaxel and Carboplatin as Chemotherapy in Patients With Metastatic Non-Small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Non-Small Cell Lung Cancer

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Trial Information

A Phase II Evaluation of Avastin in Combination With Docetaxel and Carboplatin as Chemotherapy in Patients With Metastatic Non-Small Cell Lung Cancer

Avastin® is a humanized monoclonal antibody that binds to vascular endothelial growth factor
(VEGF). VEGF plays an important role in the growth of both normal and abnormal blood
vessels. Avastin® is designed to prevent or slow down the growth of cancer cells by
blocking the effects of VEGF.

Docetaxel and carboplatin are standard chemotherapy drugs that have been approved by the FDA
for the treatment of NSCLC. Docetaxel and carboplatin are designed to work by stopping the
division of cancer cells.

If you are found to be eligible, you will begin receiving Avastin®, docetaxel, and
carboplatin. Avastin®, carboplatin, and docetaxel will be given by vein once every 3 weeks.
The first dose of Avastin® will be given over 90 minutes. The second dose of Avastin® will
be given over 60 minutes. All other doses of Avastin® will be given over 30 minutes.
Carboplatin and docetaxel will always be given over 30 minutes. They will be given on the
same day every 3 weeks (1 cycle). You may receive up to 6 cycles of treatment. You will
receive standard premedication with dexamethasone to help decrease the risk of side effects.
Dexamethasone will be taken before you receive your docetaxel infusion.

During the study, you will have blood tests (about 2 teaspoons) every 3 weeks to look at
your blood counts. These samples will be used only for routine lab tests. You will be seen
by a physician every 3 weeks and given a physical exam. Your blood pressure will be
monitored, and you will be asked about any side effects you are experiencing. A performance
status evaluation will also be done. In addition, you will have a urine test every 2 cycles
of treatment.

After 2 cycles of treatment (6 weeks), you will have a chest x-ray and computerized
tomography (CT) or magnetic resonance imaging (MRI) scan to evaluate the status of the
disease. These will be repeated every 2 cycles. Your continued participation in this study
depends on how your cancer responds to the study drugs. Your doctor may decide to take you
off this study if you experience significant side effects or your medical condition worsens.
You may continue receiving bevacizumab for as long as your cancer responds to study

You will be followed-up on by phone or at routine clinic visits for at least 12 months to
monitor your condition and disease status.

This is an investigational study. Avastin® has been approved by the FDA for the treatment
of colorectal cancer. Docetaxel and carboplatin are FDA approved and commercially
available. The use of these drugs together in this study is experimental. A total of 50
patients will take part in this study. All participants will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Men and women, at least 18 years old, with histologically confirmed, advanced stage
IIIB or IV NSCLC for whom no curative options exist and for whom docetaxel and
carboplatin is a reasonable treatment option;

2. At least 1 target lesion that is unidimensionally measurable as defined by the
Response Evaluation Criteria in Solid Tumors (RECIST) and has not been previously

3. Eastern Cooperative Oncology Group Performance Status of 0 or 1, (determined within 2
weeks prior to receiving study medication;

4. Ability to understand and adhere to the protocol requirements, and give informed

5. Use of effective means of contraception (men and women) in subjects of child-bearing
potential. Child-bearing potential is defined as follows: A woman of childbearing
potential is a sexually mature woman who has not undergone a hysterectomy or who has
not been naturally postmenopausal for at least 12 consecutive months (i.e., who has
had menses at any time in the preceding 12 consecutive months).

Exclusion Criteria:

1. Patients who have had docetaxel in nonradiosensitizing therapy

2. Patients who have received prior full dose systemic chemotherapy for NSCLC (ie
neoadjuvant, adjuvant, or metastatic) within the last 6 months.

3. ECOG status of 2 or greater

4. Screening clinical laboratory values:*ANC of <1,500/µL *Platelet count of <75,000/µL
* INR >/= 1.5 *T bilirubin elevation above normal (MDACC upper normal limit is 1.0
mg/dL) *Serum creatinine of >2.0 mg/dL *Hemoglobin of <9 mg/dL (may be transfused or
receive epoetin alfa [e.g., Epogen®] to maintain or exceed this level) *The pt is
ineligible if: 1.alk phos>5xULN; 2.AST or ALT >5xULN; 3.alk phos >1xULN but 2.5xULN AND AST or ALT >1.5xULN but 2.5xULN but or ALT > 1xULN but2.5xULN but >1.5xULN but
5. Inability to comply with study and/or follow-up procedures

6. History of other disease, active infection, metabolic dysfunction , physical
examination finding, or clinical laboratory finding which is uncontrolled requiring
medical intervention giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that might affect the
interpretation of the results of the study or render the subject at high risk from
treatment complications.

7. Current, recent (within 4 weeks of the first infusion of this study), or planned
participation in an experimental drug study other than a bevacizumab cancer study

8. Prior exposure to anti-VEGF therapy

9. Blood pressure of > 140/90 mmHg as documented in two consecutive blood pressure
readings within 4 hours

10. Any prior history of hypertensive crisis or hypertensive encephalopathy

11. New York Heart Association (NYHA) Grade II or greater congestive heart failure

12. History of myocardial infarction or unstable angina within 6 months

13. History of stroke or transient ischemic attack within 6 months

14. Significant vascular disease (e.g., aortic aneurysm, aortic dissection)

15. Evidence of bleeding diathesis or coagulopathy

16. Presence of central nervous system or brain metastases at any time

17. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 0, anticipation of need for major surgical procedure during the course
of the study

18. Minor surgical procedures, fine needle aspirations or core biopsies within 7 days
prior to Day 0

19. Pregnant (positive pregnancy test) or lactating

20. 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 < 1g of protein in 24 hours to be eligible).

21. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to Day 0

22. Serious, non-healing wound, ulcer, or bone fracture

23. Lung carcinoma of squamous cell histology or any histology in close proximity to a
major vessel, cavitation.

24. History of hemoptysis (bright red blood of 1/2 teaspoon or more)

25. Full dose anticoagulation, chronic use of Aspirin (>325 mg/day) or NSAIDs

26. Inability to comply with study and/or follow-up procedures

Type of Study:


Study Design:

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

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Time Frame:

Baseline (enrollment) to 12 months or disease progression/death

Safety Issue:


Principal Investigator

William N. William Jr., MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

December 2005

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • Bevacizumab
  • Carboplatin
  • Docetaxel
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF
  • Paraplatin®
  • Taxotere
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030
Lyndon Baines Johnson General Hospital Houston, Texas  77030