Clinical trial NCT00807170: 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
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer (NSCLC)
Keywords: Non-small Cell Lung Cancer (NSCLC)
Whole Brain Radiotherapy
metastasis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-12-11
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: To investigate the maximum tolerated dose of Vandetanib and concurrent WBRT in patients with NSCLC and brain metastases
timeFrame: All evaluable patients (all registered patients who receive at least opne dose of study medication) who have completed week 9 study period
Secondary outcomes:
measure: To investigate the time to clinical and radiological progression of brain metastases
timeFrame: Until disease progression
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Research site
city: Groningen
country: Netherlands
facility: Research site
city: Maastricht
country: Netherlands
facility: Research site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: