Study of Vandetanib Combined With Chemotherapy to Treat Advanced Non-small Cell Lung Cancer
A Randomized Phase II Study Evaluating Vandetanib (ZD6474) in Combination With Docetaxel and Carboplatin Followed by Placebo or Maintenance Therapy With Vandetanib in Patients With IIIb, IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
2 other identifiers
interventional
162
1 country
30
Brief Summary
It has been shown in previous studies that the ability to treat lung cancer could be significantly improved by not only targeting the tumor cells directly with chemotherapy, but also by cutting off the blood supply to the cancer cells. Blood vessels that supply the tumor are formed through a process called angiogenesis. Vandetanib is an investigational drug that acts by producing what is called an anti-angiogenic effect. An Anti-angiogenic effect is able to inhibit the development of new blood vessels required by tumors to survive by blocking the growth factors needed to form new blood vessels. The purpose of this study is to determine if the addition of vandetanib to a standard chemotherapy regimen will slow or stop the growth of the cancer for a longer period of time compared to the time period generally gained from the use of standard chemotherapy alone
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 lung-cancer
Started Apr 2008
30 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
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 27, 2008
CompletedFirst Posted
Study publicly available on registry
May 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
July 10, 2012
CompletedMay 30, 2018
April 1, 2018
2.8 years
May 27, 2008
June 6, 2012
April 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
Time from randomization (prior to induction) to first evidence of disease progression or death without progression. Participants alive without progression were censored at the date of last disease evaluation.
Assessed every 2 cycles (1 cycle = 3 weeks during induction and 4 weeks during maintenance))
Secondary Outcomes (2)
Objective Response Rate
Assessed every 2 cycles (1 cycle = 3 weeks during induction and 4 weeks during maintenance))
Progression-free Survival
every 2 cycles (every 6 weeks during induction, every 8 weeks during maintenance)
Study Arms (2)
Vandetanib Maintenance
ACTIVE COMPARATORDocetaxel day 1, carboplatin day 1 + vandetanib induction days 1 through 21 (daily) of a 28-day cycle for 4 cycles. If free of disease progression after 4 cycles, vandetanib maintenance daily until progression.
Placebo Maintenance
PLACEBO COMPARATORDocetaxel day 1, carboplatin day 1 + vandetanib induction days 1 through 21 (daily) of a 28-day cycle for 4 cycles. If free of disease progression after 4 cycles, placebo maintenance daily until progression.
Interventions
100 mg daily by mouth
(75mg/m2) IV (in the vein) on day 1 of a 21-day cycle for 4 cycles or until disease progression
IV (in the vein) to area under the curve (AUC) of 6 on day 1 of a 21 day cycle, for 4 cycles or until disease progression
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed non-small cell lung cancer
- Advanced disease (stage IIIB disease \[malignant pleural or pericardial effusion seen on CT or Chest X-ray, any N, M0\] or stage IV disease \[Any T, any N, M1: distant metastases\]) that is primary or recurrent
- Measurable disease according to the RECIST criteria
- ECOG Performance Status 0 or 1
- Adequate organ function, as evidenced by ALL the following
- Absolute neutrophil count (ANC) ≥ 1500/mm³ and platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 gm/dL
- Total bilirubin ≤ 1 X institutional ULN; if patient has Gilbert's disease, then patient must have isolated hyperbilirubinemia (e.g. no other liver function test abnormality), with maximum bilirubin ≤ 2 X institutional ULN.
- AST, ALT and alkaline phosphatase (Alk Phos) must be ≤ 1.5 ULN
- Creatinine ≤ 1.5 X institutional ULN or calculated creatinine clearance ≥ 60 ml/min
- Potassium between 4 mEq/L and institutional ULN (supplementation may be used),
- Calcium (ionized or adjusted for albumin)within institutional normal limits
- Magnesium within institutional normal limits (supplementation may be used)
- No prior cytotoxic chemotherapy or targeted therapy for advanced or metastatic disease (Prior adjuvant therapy for lung cancer allowed if completed \> 1 year prior to registration)
- Able to take oral medication
You may not qualify if:
- Myocardial infarction, superior vena caval syndrome, NYHA classification of heart disease ≥ 2 within the 3 months prior to entry
- History of an uncontrolled or recurrent ventricular, supraventricular or nodal arrhythmia that requires treatment
- Hypertension not controlled by medication
- Peripheral or sensory neuropathy \> grade 1
- Known hypersensitivity to carboplatin or docetaxel
- Active infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PrECOG, LLC.lead
- AstraZenecacollaborator
Study Sites (30)
Boca Raton Community Hospital
Boca Raton, Florida, 33486, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
SwedishAmerican Hospital
Rockford, Illinois, 61104, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Ochsner Clinic
New Orleans, Louisiana, 70121, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
St. Joseph Mercy Hospital- Ann Arbor
Ann Arbor, Michigan, 48106, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, 55416, United States
Ocean Medical Center
Brick, New Jersey, 08724, United States
Morristown Memorial Hospital
Morristown, New Jersey, 07960, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Riverview Medical Center
Red Bank, New Jersey, 07701, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Aultman Hospital
Canton, Ohio, 44710, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Hematology & Oncology of NEPA
Dunmore, Pennsylvania, 18512, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17604, United States
Central PA Hematology & Medical Oncology Associaties
Lemoyne, Pennsylvania, 17043, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141, United States
The Reading Hospital and Medical Center
Reading, Pennsylvania, 19610, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16803, United States
Sanford Clinic
Sioux Falls, South Dakota, 57104, United States
Meharry Medical College
Nashville, Tennessee, 37208, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Charleston Area Medical Center
Charleston, West Virginia, 25304, United States
St. Vincent Hospital
Green Bay, Wisconsin, 45301, United States
Gundersen Lutheran
La Crosse, Wisconsin, 54601, United States
Regional Cancer Center
Waukesha, Wisconsin, 53188, United States
Related Publications (1)
Aisner J, Manola JB, Dakhil SR, Stella PJ, Sovak MA, Schiller JH. Vandetanib plus chemotherapy for induction followed by vandetanib or placebo as maintenance for patients with advanced non-small-cell lung cancer: a randomized phase 2 PrECOG study (PrE0501). J Thorac Oncol. 2013 Aug;8(8):1075-83. doi: 10.1097/JTO.0b013e3182937317.
PMID: 23689430RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- PrECOG
Study Officials
- STUDY CHAIR
Joseph Aisner, MD
Rutgers Cancer Institute of New Jersey
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2008
First Posted
May 30, 2008
Study Start
April 1, 2008
Primary Completion
January 1, 2011
Study Completion
April 1, 2011
Last Updated
May 30, 2018
Results First Posted
July 10, 2012
Record last verified: 2018-04