The purpose of this clinical trial is to test whether treatment of patients with NSCLC with erlotinib plus sunitinib is better than treatment with erlotinib plus placebo. All patients enrolling in this study will receive treatment with erlotinib.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Overall Survival
Secondary outcome
Progression-Free Survival
Objective Response Rate
One-year Survival
Duration of Response
Type, incidence, severity, timing, seriousness, and relationship to study
therapy of adverse events; laboratory abnormalities
Patient-reported outcomes as measured by the EQ-5D questionnaire
Background summary
Erlotinib is used to treat patients with advanced or metastatic NSCLC after
failure of one or two prior chemotherapy regimens. Erlotinib is an Epidermal
Growth Factor Receptor (EGFR) inhibitor - it blocks the signal that EGFR sends
to the cancer cells to make them grow.
Sunitinib is approved by the US FDA for the treatment of Gastrointestinal
Stromal Tumor - a rare type of gastrointestinal cancer - and for the treatment
of advanced kidney cancer. Sunitinib is an investigational agent in NSCLC that
is thought to work by killing cancer cells and slowing tumor growth and the
growth of new blood vessels that supply nutrients to tumors. Sunitinib does
this by blocking molecules on the surface of cancer cells and the surrounding
blood vessels that send the signals to grow. To date, over 7000 patients with
advanced cancer have been treated with sunitinib. Studies in patients with
NSCLC are in early stages and have not yet proven that sunitinib is effective
in this disease; however, a few patients with NSCLC who were treated with
sunitinib have shown tumor responses to treatment.
Study objective
The purpose of this clinical trial is to test whether treatment of patients
with NSCLC with erlotinib plus sunitinib is better than treatment with
erlotinib plus placebo. All patients enrolling in this study will receive
treatment with erlotinib.
Study design
This study is a multinational, multicenter, randomized, double-blind,
controlled, phase 3 efficacy and safety study of sunitinib combined with
erlotinib versus placebo combined with erlotinib in patients with
advanced/metastatic non-small cell lung cancer.
Treatment on study will be administered in 4-week cycles. The starting dose of
erlotinib will be 150 mg daily administered orally and of sunitinib 37,5 mg
daily administered orally. The dosage may be elevated or reduced based on
tolerability by the investigator.
Disease progression and overall survival will be assessed in all patients who
will be followed until death.
Intervention
erlotinib: All patients will receive erlotinib. Erlotinib tablets will be
taken every day by mouth at a starting dose 150 mg continuously.
Sunitinib: capsules of sunitinib at 37.5 mg or placebo once daily continuously.
The study doctor might change the dosage if in his opinion it would be better.
Study burden and risks
number of blooddraws: 16 x
number of physical examinations: 13 x
number of questionnaires: 14 x
number of CT/MRI: 7 x
number of bone scans: 1 x
number of brainscans: 1 x
The most common adverse events of sunitinib are: diarrhea, nausea, upset
stomach, taste disturbances, inflammation of mucous membranes, vomiting,
constipation etc. (see patient information)
The most common side effects are rash and diarrhea (see patient information)
Risk of Blood Drawing: a risk of bruising, pain, or infection at the site of
the blood draw.
Radiation Risks from Imaging Studies: The amount of radiation exposure you may
receive from these standard diagnostic tests is considered small, and will not
adversely affect the treatment of your disease.
Contrast dye for CT scans: hives and itching or other allergic symptoms
MRI scans: Because of a strong magnetic field metal prostheses or pace makers
might malfunction
Rivium Westlaan 142
2909 LD Capelle a/d IJssel
NL
Rivium Westlaan 142
2909 LD Capelle a/d IJssel
NL
Listed location countries
Age
Inclusion criteria
Histologically or cytologically proven diagnosis of NSCLC with evidence of disease that is recurrent and for which erlotinib treatment is clinically indicated;Prior treatment with 1 or 2 chemotherapy regimens ;Disease progression during or after first-line chemotherapy
Exclusion criteria
Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitors, or other angiogenesis inhibitors;Treatment with sunitinib and/or erlotinib if it is contraindicated according to the local prescribing information
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-001915-52-NL |
| ClinicalTrials.gov | NCT00457392 |
| CCMO | NL17998.068.07 |