Avastin/Docetaxel/Carboplatin in Non-Small Cell Lung Cancer
A Phase II Evaluation of Avastin in Combination With Docetaxel and Carboplatin as Chemotherapy in Patients With Metastatic Non-Small Cell Lung Cancer
2 other identifiers
interventional
43
1 country
2
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 also be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer
Started Dec 2005
Longer than P75 for phase_2 nonsmall-cell-lung-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 5, 2005
CompletedFirst Submitted
Initial submission to the registry
December 29, 2005
CompletedFirst Posted
Study publicly available on registry
January 2, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2017
CompletedResults Posted
Study results publicly available
May 11, 2020
CompletedMay 11, 2020
April 1, 2020
11.6 years
December 29, 2005
April 8, 2020
April 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Progression-Free Survival (PFS)
Bevacizumab has recently been demonstrated to prolong overall survival when added to carboplatin and paclitaxel for chemotherapy-naı¨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-naı¨ve patients with advanced, on squamous NSCLC.
Baseline up to 12 months or disease progression/death
Secondary Outcomes (2)
Overall Survival (OS)- 5 Years
Baseline start of treatment to death, assessed up to 6 years
Disease Control Rate
Baseline start of treatment to death, assessed up to 6 years
Study Arms (1)
Avastin + Docetaxel + Carboplatin
EXPERIMENTALAvastin 15 mg/kg intravenously (IV) every 3 weeks. Docetaxel 75 mg/m2 IV every 3 weeks. Carboplatin AUC 6 IV every 3 weeks.
Interventions
15 mg/kg intravenously (IV) every 3 weeks
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Genentech, Inc.collaborator
Study Sites (2)
Lyndon Baines Johnson General Hospital
Houston, Texas, 77030, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. John V Heymach, PHD/ Chair, Thoracic-Head & Neck Med Onc
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Vali Papadimitrakopoulou, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2005
First Posted
January 2, 2006
Study Start
December 5, 2005
Primary Completion
July 27, 2017
Study Completion
July 27, 2017
Last Updated
May 11, 2020
Results First Posted
May 11, 2020
Record last verified: 2020-04