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Malignant Pleural Effusion With ZD6474
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, December 2008
Sponsors and Collaborators: M.D. Anderson Cancer Center
Department of Defense
AstraZeneca
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00402896
  Purpose

Primary Objective:

1. To examine the effect of ZD6474 on the time between placement of an indwelling pleural catheter and its removal.

Secondary Objectives:

  1. Measure the amount of pleural fluid drainage.
  2. Study expression of VEGF, IL-6, IL-8, bFGF, LDH, protein, pH in serum and pleural effusion.
  3. Study expression of VEGFR, EGFR and activated receptors on tumor cells collected from effusion.
  4. Measure level of circulating endothelial cells and circulating endothelial progenitor cells in serum and pleural effusion.
  5. Evaluate the effect of the study agent on tumor burden with chest CTs.
  6. Evaluate the effect of the study agent on QOL and shortness of breath using standard questionnaires.

Condition Intervention Phase
Lung Cancer
Pleural Effusion
Drug: ZD6474
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Epidermal Growth Factor Vandetanib Tyrosine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Treatment of Malignant Pleural Effusion With ZD6474, a Novel Vascular Endothelial Growth Factor Receptor (VEGFR) and Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To learn the effect of ZD6474 on the amount of time between placement of an indwelling pleural catheter and the catheter's removal in patients with malignant pleural effusion. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To look at the effect that ZD6474 has on tumor cells, biological characteristics of cells in the body, rate of fluid build-up around the lungs, tumor size, and thickness of blood vessels. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
  • The effect that this drug has on quality of life and shortness of breath will also be examined. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: October 2006
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
ZD6474
Drug: ZD6474
300 mg/day orally for 10 weeks.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with pleural effusion requiring placement of an indwelling intrapleural denver catheter for recurrent symptomatic malignant pleural effusion.
  • Pathologic documentation of NSCLC.
  • Performance status 0 to 2 (ECOG scale).
  • INR </= 2.5
  • Signed informed consent prior to any study related procedures.
  • Subject must be female or male age 18 years or over.

Exclusion Criteria:

  • Chemotherapy or other anticancer therapy in the 3 weeks prior to study. Palliative radiotherapy will be allowed to extra thoracic sites 2 weeks prior to study.
  • No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for at least two years.
  • Laboratory results sustained at:Neutrophils less than 1.5x10^9/L or platelets less than 100x10^9/L; Serum bilirubin >1.5 x the upper limit of reference range (ULRR);Serum creatinine>1.5xULRR or CrCl </=50 mL/minute(calculated by Cockcroft-Gault formula). Potassium,<4.0 mmol despite supplementation;serum calcium (ionized or adjusted for albumin),or magnesium out of normal range despite supplementation;Alanine aminotransferase(ALT)or aspartate aminotransferase(AST) > 2.5 x ULRR or alkaline phosphatase(ALP)> 2.5 x ULRR,or > 5 x ULRR if judged by the investigator to be related to liver metastases
  • Serious underlying medical condition that would impair the ability of the patient to receive protocol treatment, specifically cardiac diseases, uncontrolled hypertension or renal diseases.
  • Diagnosis of post-obstructive pneumonia or other serious infection in the 14 days prior to registration.
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  • Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
  • Clinically significant cardiovascular event such as Myocardial infarction; New York Heart Association (NYHA) classification of heart disease >/=2 within 3 months before entry; or presence of cardiac disease that in the opinion of the Investigator increase the risk of ventricular arrhythmia.
  • History of arrhythmia (multifocal premature ventricular contractions (PVCs), bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is not excluded.
  • Previous history of QTc prolongation with other medication that required discontinuation of that medication.
  • Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age.
  • QTc with Bazett's correction that is unmeasurable, or >/=480 msec on screening ECG. If a patient has QTc >/=480 msec on screening ECG, the screen ECG may be repeated twice (at least 24 hours apart). The average QTc from the three screening ECGs must be <480 msec in order for the patient to be eligible for the study). Patients who are receiving a drug that has a risk of QTc prolongation are excluded if QTc is >/= 460 msec.
  • Any concomitant medication that may cause QTc prolongation or induce Torsades de Pointes.
  • Hypertension not controlled by medical therapy (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg).
  • Women who are currently pregnant or breast feeding.
  • Participation in a clinical trial of any investigational agents within 30 days prior to commencing study treatment.
  • In 2nd line or later, the last dose of prior chemotherapy is discontinued less than 3 weeks before the start of study therapy.
  • In 2nd line or later, the last radiation therapy discontinued less than 2 weeks before the start of study therapy except palliative radiotherapy.
  • If it is in 2nd line or later, any unresolved toxicity greater than CTC grade 1 from previous anti-cancer therapy.
  • Previous enrollment or randomization of treatment in the present study.
  • Patients with pre-existing placement of intrapleural catheter.
  • Presence of left bundle branch block (LBBB.)
  • Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy.
  • Patients may not have a history of a bleeding diathesis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00402896

Contacts
Contact: Christine Alden, R.N. 713-792-0734 cmalden@mdanderson.org

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Christine Alden, R.N.     713-792-0734     cmalden@mdanderson.org    
Principal Investigator: Roy S. Herbst, M.D., PhD.            
Sponsors and Collaborators
M.D. Anderson Cancer Center
AstraZeneca
Investigators
Principal Investigator: Roy S. Herbst, M.D., PhD. U.T.M.D. Anderson Cancer Center
  More Information

UT MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: U.T.M.D. Anderson Cancer Center ( Roy S. Herbst, MD, PhD/Professor )
Study ID Numbers: 2005-0929
Study First Received: November 20, 2006
Last Updated: December 22, 2008
ClinicalTrials.gov Identifier: NCT00402896  
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Lung Cancer
Non-Small Cell Lung Cancer
Pleural Effusion
Indwelling Intrapleural Denver Catheter
ZD6474
Vascular Endothelial Growth Factor Receptor
VEGFR
Epidermal Growth factor Receptor
EGFR
Tyrosine Kinase Inhibitor

Study placed in the following topic categories:
Thoracic Neoplasms
Pleural Effusion
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Pleural Diseases
Lung Diseases
Pleural Effusion, Malignant
Endothelial Growth Factors
Carcinoma, Non-Small-Cell Lung
Pleural Neoplasms

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009