Malignant Pleural Effusion With ZD6474

NCT00402896 | Terminated Phase 2 Results

• 3 other identifiers: 2005-0929NCI-2012-02082W81XWH-05-2-0027
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is 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. This study will also 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. The effect that this drug has on quality of life and shortness of breath will also be examined.

Conditions

Lung Cancer; Pleural Effusion

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Median Time to Pleurodesis

  Time to pleurodesis from initiation of treatment to catheter removal as measure of pleural effusion Improvement (amount of pleural fluid drainage) where objective was to examine whether ZD6474 would help participants to improve the condition of pleural effusion, and thus remove the catheter earlier. Cox model analysis applied to examine the effect of covariates on the time to catheter removal.

  Time from initiation of treatment and catheter insertion up to a maximum of 10 weeks

Study Arms (1)

ZD6474

EXPERIMENTAL

300 mg/day orally for 10 weeks.

Drug: ZD6474

Interventions

ZD6474 DRUG

300 mg/day orally for 10 weeks.

Also known as: Vascular Endothelial Growth Factor Receptor, Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor

ZD6474

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (Eastern Cooperative Oncology Group (ECOG) scale)
• International Normalized Ratio (INR) \</= 2.5
• Signed informed consent prior to any study related procedures
• Subject must be female or male age 18 years or over

You may not qualify if:

• 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 \</=30 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 corrected QT interval (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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• United States Department of Defense: collaborator
• AstraZeneca: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Massarelli E, Onn A, Marom EM, Alden CM, Liu DD, Tran HT, Mino B, Wistuba II, Faiz SA, Bashoura L, Eapen GA, Morice RC, Jack Lee J, Hong WK, Herbst RS, Jimenez CA. Vandetanib and indwelling pleural catheter for non-small-cell lung cancer with recurrent malignant pleural effusion. Clin Lung Cancer. 2014 Sep;15(5):379-86. doi: 10.1016/j.cllc.2014.04.002. Epub 2014 May 14.

  PMID: 24913066 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lung Neoplasms; Pleural Effusion; Carcinoma, Non-Small-Cell Lung

Interventions

vandetanib; Receptors, Vascular Endothelial Growth Factor

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pleural Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Receptor Protein-Tyrosine Kinases; Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cell Surface; Membrane Proteins; Receptors, Growth Factor; Receptors, Peptide

Results Point of Contact

• Title: Carlos A. Jimenez, MD/Professor, Pulmonary Medicine
• Organization: The University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Carlos Jimenez, M.D.

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

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: November 20, 2006
• First Posted: November 22, 2006
• Study Start: October 1, 2006
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 9, 2016
• Results First Posted: March 9, 2016

Record last verified: 2016-02

Locations

US (1)