Malignant Pleural Effusion With ZD6474

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00402896
First received: November 20, 2006
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Pleural Effusion
Drug: ZD6474
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pleural Effusion Improvement (amount of pleural fluid drainage) [ Time Frame: Time from initiation of the treatment, i.e., time of inserting Denver catheter, to the removal of Denver catheter ] [ Designated as safety issue: No ]
    Primary objective is to examine whether ZD6474 would help patients 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.


Enrollment: 28
Study Start Date: October 2006
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZD6474
300 mg/day orally for 10 weeks.
Drug: ZD6474
300 mg/day orally for 10 weeks.
Other Names:
  • Vascular Endothelial Growth Factor Receptor
  • Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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
  2. 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
  3. 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
  4. Serious underlying medical condition that would impair the ability of the patient to receive protocol treatment, specifically cardiac diseases, uncontrolled hypertension or renal diseases
  5. Diagnosis of post-obstructive pneumonia or other serious infection in the 14 days prior to registration
  6. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  7. 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
  8. 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
  9. 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
  10. Previous history of corrected QT interval (QTc) prolongation with other medication that required discontinuation of that medication
  11. Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age
  12. 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
  13. Any concomitant medication that may cause QTc prolongation or induce Torsades de Pointes
  14. Hypertension not controlled by medical therapy (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg)
  15. Women who are currently pregnant or breast feeding
  16. Participation in a clinical trial of any investigational agents within 30 days prior to commencing study treatment
  17. In 2nd line or later, the last dose of prior chemotherapy is discontinued less than 3 weeks before the start of study therapy
  18. In 2nd line or later, the last radiation therapy discontinued less than 2 weeks before the start of study therapy except palliative radiotherapy
  19. If it is in 2nd line or later, any unresolved toxicity greater than CTC grade 1 from previous anti-cancer therapy
  20. Previous enrollment or randomization of treatment in the present study
  21. Patients with pre-existing placement of intrapleural catheter
  22. Presence of left bundle branch block (LBBB.)
  23. Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy
  24. Patients may not have a history of a bleeding diathesis
  25. Currently active diarrhea that may affect the ability of the patient to absorb the ZD6474 or tolerate diarrhea
  26. Concomitant medications that are potent inducers (rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital and St. John's Wort) of CYP3A4 function
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402896

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
AstraZeneca
Investigators
Principal Investigator: Carlos Jimenez, M.D. M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00402896     History of Changes
Other Study ID Numbers: 2005-0929, NCI-2012-02082, W81XWH-05-2-0027
Study First Received: November 20, 2006
Last Updated: June 20, 2014
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

Additional relevant MeSH terms:
Lung Neoplasms
Pleural Effusion
Pleural Effusion, Malignant
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pleural Diseases
Pleural Neoplasms
Endothelial Growth Factors
Mitogens
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014