Investigate the Maximum Tolerated Dose of Vandetanib and Concurrent Whole Brain Radiotherapy (WBRT) in Patients With Non-small Cell Lung Cancer (NSCLC) and Brain Metastases
This study has been terminated.
(Very slow recruitment)
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00807170
First received: December 9, 2008
Last updated: January 11, 2011
Last verified: January 2011
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Purpose
A clinical study to investigate the maximum tolerated dose of Vandetanib and concurrent WBRT in patients with NSCLC and brain metastases. All patients will receive WBRT, 10 fractions of 3 Gy. Patients will start 7 days prior to start of radiation treatment with Vandetanib. Total treatment time with Vandetanib is 3 weeks (21 days). Patients will have the opportunity to continue Vandetanib until progression at a dose of 300 mg. This multi-centre study will be conducted in a minimum of 9 patients and a maximum of 18 patients at 3 sites.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer |
Drug: ZD6474 (Vandetanib) Radiation: Whole Brain Radiotherapy (WBRT) Drug: ZD6474 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of ZD6474 (Vandetanib) Concurrent With Whole Brain Radiotherapy for the Treatment of Brain Metastases in Patients With Non-small Cell Lung Cancer (NSCLC) |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- To investigate the maximum tolerated dose of Vandetanib and concurrent WBRT in patients with NSCLC and brain metastases [ Time Frame: All evaluable patients (all registered patients who receive at least opne dose of study medication) who have completed week 9 study period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To investigate the time to clinical and radiological progression of brain metastases [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]
| Enrollment: | 5 |
| Study Start Date: | May 2009 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ZACTIMA TM |
Drug: ZD6474 (Vandetanib)
100 mg as a once daily oral dose, 21 days
Other Name: ZACTIMA TM
Radiation: Whole Brain Radiotherapy (WBRT)
Drug: ZD6474
200 mg as a once daily oral dose, 21 days
Other Name: ZACTIMA TM
Drug: ZD6474
300 mg as a once daily oral dose, 21 days
Other Name: ZACTIMA TM
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female patients aged above 18 years with histologically or cytologically confirmed NSCLC and contrast-enhanced CT scan or Gadolinium-enhanced MRI confirmed brain metastases who have a performance status of 0 to 2
- No previous radiotherapy, surgery or chemotherapy for brain metastases
- Patients should not have any unstable systemic disease
Exclusion Criteria:
- Serious abnormal laboratory values
- 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 (e.g. myocardial infarction, superior vena cava syndrome (SVC), New York Heart Association (NYHA) classification of heart disease >2 within 3 months before entry; or presence of cardiac disease that, in the
- Previous randomization of treatment in the present study and/ or current participation in another clinical study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807170
Locations
| Netherlands | |
| Research site | |
| Amsterdam, Netherlands | |
| Research site | |
| Groningen, Netherlands | |
| Research site | |
| Maastricht, Netherlands | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | A. C. Dingemans, MD, PhD | University Medical Centre Maastricht, the Netherlands |
| Study Director: | H. Kamsteeg, PhD | AstraZeneca, the Netherlands |
| Study Chair: | A.C.C. Cornelissen-Poirters, MSc | AstraZeneca, the Netherlands |
| Study Director: | Peter Langmuir, MD | AZ Pharmaceuticals -US |
More Information
No publications provided
| Responsible Party: | Peter LANGMUIR, MD ZACTIMA Medical Science Senior Director, AstraZeneca Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00807170 History of Changes |
| Other Study ID Numbers: | D4200C00085, EUDRACT Number 2008-005556-24 |
| Study First Received: | December 9, 2008 |
| Last Updated: | January 11, 2011 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by AstraZeneca:
|
Non-small Cell Lung Cancer (NSCLC) Whole Brain Radiotherapy metastasis |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasm Metastasis Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013