Status:
COMPLETED
Avastin/Docetaxel/Carboplatin in Non-Small Cell Lung Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
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 d...
Eligibility Criteria
Inclusion
- 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;
- 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;
- Eastern Cooperative Oncology Group Performance Status of 0 or 1, (determined within 2 weeks prior to receiving study medication;
- Ability to understand and adhere to the protocol requirements, and give informed consent
- 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
- Patients who have had docetaxel in nonradiosensitizing therapy
- Patients who have received prior full dose systemic chemotherapy for NSCLC (ie neoadjuvant, adjuvant, or metastatic) within the last 6 months.
- Eastern Cooperative Oncology Group (ECOG) status of 2 or greater
- 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
- Inability to comply with study and/or follow-up procedures
- 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.
- 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
- Prior exposure to anti-VEGF therapy
- Blood pressure of \> 140/90 mmHg as documented in two consecutive blood pressure readings within 4 hours
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months
- History of stroke or transient ischemic attack within 6 months
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
- Evidence of bleeding diathesis or coagulopathy
- Presence of central nervous system or brain metastases at any time
- 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
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
- Pregnant (positive pregnancy test) or lactating
- 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).
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
- Serious, non-healing wound, ulcer, or bone fracture
- Lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel, cavitation.
- History of hemoptysis (bright red blood of 1/2 teaspoon or more)
- Full dose anticoagulation, chronic use of Aspirin (\>325 mg/day) or NSAIDs
- Inability to comply with study and/or follow-up procedures
Key Trial Info
Start Date :
December 5 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2017
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00271505
Start Date
December 5 2005
End Date
July 27 2017
Last Update
May 11 2020
Active Locations (2)
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1
Lyndon Baines Johnson General Hospital
Houston, Texas, United States, 77030
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030