Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase II Evaluation of Avastin in Combination With Docetaxel and Carboplatin as Chemotherapy in Patients With Metastatic Non-Small Cell Lung Cancer
Verified date | April 2020 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 43 |
Est. completion date | July 27, 2017 |
Est. primary completion date | July 27, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Lyndon Baines Johnson General Hospital | Houston | Texas |
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | Genentech, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Progression-Free Survival (PFS) | Bevacizumab has recently been demonstrated to prolong overall survival when added to carboplatin and paclitaxel for chemotherapy-nai¨ve patients with nonsquamous nonsmall-cell lung cancer (NSCLC). However, the effects of combining bevacizumab with other standards, front-line, platinum-based doublets have not been extensively explored.We designed this single treatment arm, phase 2 trial to determine whether the combination of carboplatin, docetaxel, and bevacizumab is tolerable and prolongs progression-free survival of chemotherapy-nai¨ve patients with advanced, on squamous NSCLC. | Baseline up to 12 months or disease progression/death | |
Secondary | Overall Survival (OS)- 5 Years | Secondary endpoints of the study included the assessment of overall survival, disease control rate (CR þPR þ SD, defined by RECIST16), and evaluation of the safety profile of this triple-agent regimen. All patients who received at least 1 dose of the study drug were analyzed for efficacy and toxicity endpoints. | Baseline start of treatment to death, assessed up to 6 years | |
Secondary | Disease Control Rate | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1 .0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)= CR+ PR. | Baseline start of treatment to death, assessed up to 6 years |
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