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CompletedPhase 2NCT00687297
Official study title

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

Study 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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedvandetanib induction and Docetaxel

Plus 3 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 30, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?30 U.S. locations

Locations may change over time.

Who runs it?PrECOG, LLC.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
PrECOG, LLC.
Interventions being studied
Drug: vandetanib induction; Drug: Docetaxel; Drug: Carboplatin; Drug: Placebo; Drug: Vandetanib maintenance
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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
Reasons someone may not be able to joinExclusion criteria
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Boca Raton Community HospitalBoca Raton, Florida
  • Lakeland Regional Cancer CenterLakeland, Florida
  • SwedishAmerican HospitalRockford, Illinois
  • Cancer Center of KansasWichita, Kansas
  • Ochsner ClinicNew Orleans, Louisiana
  • Greater Baltimore Medical CenterBaltimore, Maryland
  • St. Joseph Mercy Hospital- Ann ArborAnn Arbor, Michigan
  • West Michigan Cancer CenterKalamazoo, Michigan
  • Metro-Minnesota CCOPSaint Louis Park, Minnesota
  • Ocean Medical CenterBrick, New Jersey
  • Morristown Memorial HospitalMorristown, New Jersey
  • Cancer Institute of New JerseyNew Brunswick, New Jersey

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 30, 2018. Always confirm current availability with the study team.

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