Avastin/Docetaxel/Carboplatin in Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Bevacizumab (Avastin); Carboplatin; Docetaxel
Intervention description: 15 mg/kg intravenously (IV) every 3 weeks; AUC 6 IV every 3 weeks; 75 mg/m2 IV every 3 weeks
Intervention MeSH terms: Bevacizumab; Carboplatin; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Small Cell Lung Cancer; Lung Cancer; Bevacizumab; Carboplatin; Docetaxel; Avastin; NSCLC; Anti-VEGF monoclonal antibody; rhuMAb-VEGF; Paraplatin®; Taxotere

Summary:

      The goal of this clinical research study is to evaluate the effectiveness of Avastin® in
      combination with docetaxel and carboplatin in the treatment of lung cancer. The safety of
      this combination will also be studied.
    

Eligibility criteria:

        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
             irradiated;

          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
             consent

          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. Eastern Cooperative Oncology Group (ECOG) status of 2 or greater

          4. Screening clinical laboratory values:*absolute neutrophil count (ANC) of <1,500/µL
             *Platelet count of <75,000/µL * international normalized ratio (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 </=5xULN;4.alk phos >2.5xULN but </=5xULN AND AST or ALT > 1xULN but</=
             1.5xULN; 5.alk phos >2.5xULN but</=5xULN AND AST or ALT >1.5xULN but </=5xULN

          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