Loading clinical trials...
Loading clinical trials...
Assessment of Feasibility and Safety of the Addition of ZD6474 (Zactima) to Carboplatin and Paclitaxel Administered Neo-Adjuvantly in Stage IB, II and T3, N1 Non-Small Cell Lung Cancer (NSCLC)
RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vandetanib together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving vandetanib together with carboplatin and paclitaxel works in treating patients with stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.
OBJECTIVES: Primary * Determine the feasibility of neoadjuvant vandetanib in combination with carboplatin and paclitaxel in patients with resectable stage IB, II, or IIIA non-small cell lung cancer. Secondary * Assess the 30-day postoperative mortality rate in these patients. * Assess the toxicity of this regimen in these patients. * Determine the percentage of patients who complete all planned courses of therapy. * Assess the clinical response rate in patients treated with this regimen. * Assess the pathologic complete response rate in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral vandetanib once daily on days 1-21. Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 3 courses. Patients undergo surgery at least 3 weeks after the last course of chemotherapy. PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Age
18 - 120 years
Sex
ALL
Healthy Volunteers
No
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Start Date
July 1, 2007
Primary Completion Date
January 1, 2008
Completion Date
October 1, 2008
Last Updated
March 26, 2019
2
ACTUAL participants
carboplatin
DRUG
paclitaxel
DRUG
Zactima
DRUG
neoadjuvant therapy
PROCEDURE
Lead Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
NCT07190248
NCT06498635
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07336732