Clinical trial NCT00459121
Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer
Sponsor: Barbara Ann Karmanos Cancer Institute
Start date: 2007-07-01; Completion date: 2008-10-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: Zactima- 100 mg orally daily, starting on day 1 of cycle 1. Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 Duration of each cycle: 21 days. The last dose of zactima will be on the first day of the last cycle.

Neoadjuvant Surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment.
Interventions: intervention 1: carboplatin intervention 2: paclitaxel intervention 3: Zactima intervention 4: neoadjuvant therapy
Intervention descriptions: intervention 1: Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 intervention 2: Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. intervention 3: Zactima- 100 mg orally daily, starting on day 1 of cycle 1. intervention 4: Neoadjuvant surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment.

Protocol documents: