Study of Vandetanib Combined With Chemotherapy to Treat Advanced Non-small Cell Lung Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Lung Cancer, Non Small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT00687297

Run by

PrECOG, LLC.

People needed

162

Starts

2008-04-01

Expected to finish

2011-04-01

Last updated by the study team

2018-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Boca Raton Community Hospital — Boca Raton, Florida, United States
• Lakeland Regional Cancer Center — Lakeland, Florida, United States
• SwedishAmerican Hospital — Rockford, Illinois, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Ochsner Clinic — New Orleans, Louisiana, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• St. Joseph Mercy Hospital- Ann Arbor — Ann Arbor, Michigan, United States
• West Michigan Cancer Center — Kalamazoo, Michigan, United States
• Metro-Minnesota CCOP — Saint Louis Park, Minnesota, United States
• Ocean Medical Center — Brick, New Jersey, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Riverview Medical Center — Red Bank, New Jersey, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Aultman Hospital — Canton, Ohio, United States
• Abington Memorial Hospital — Abington, Pennsylvania, United States
• Hematology & Oncology of NEPA — Dunmore, Pennsylvania, United States
• Lancaster General Hospital — Lancaster, Pennsylvania, United States
• Central PA Hematology & Medical Oncology Associaties — Lemoyne, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Albert Einstein Cancer Center — Philadelphia, Pennsylvania, United States
• The Reading Hospital and Medical Center — Reading, Pennsylvania, United States
• Mount Nittany Medical Center — State College, Pennsylvania, United States
• Sanford Clinic — Sioux Falls, South Dakota, United States
• Meharry Medical College — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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