Vandetanib, Carboplatin, and Paclitaxel in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Can Be Removed by Surgery
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.
Procedure: neoadjuvant therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- Complete Resection (R0) Rate [ Time Frame: Following three cycles of pre-operative zactima and carboplatin/paclitaxel ] [ Designated as safety issue: No ]
- Post-Operative Mortality Rate [ Time Frame: at 30 days ] [ Designated as safety issue: No ]
- Assess Toxicity of This Regimen and the Percentage of Patients Completing All Planned Cycles of Therapy [ Time Frame: Weekly for the first cycle; Thereafter within 72 hours of each dose of carboplatin/paclitaxel ] [ Designated as safety issue: Yes ]Serum chemistry includes Albumin, alkaline phosphatase, total bilirubin, bicarbonate, BUN, calcium, chloride, creatinine, glucose, potassium, total protein, SGOT [AST], SGPT [ALT], sodium, laboratory tests should be done on a weekly basis for the first cycle. After the first cycle laboratory tests should be done within 72 hours of each dose of carboplatin/paclitaxel.
- Assess the Clinical Response Rate of the Proposed Pre-operative Regimen [ Time Frame: End of three cycles of treatment ] [ Designated as safety issue: Yes ]Patients will undergo tumor evaluation when all of the three cycles have been completed unless the treating physician has concerns regarding tumor progression. If the patient has undergone tumor evaluation prior to the last cycle the patient will require repeat tumor assessment within 4 weeks of completion of the last cycle of therapy
- Assess the Complete Pathologic Complete Response (CR) Rate With This Regimen. [ Time Frame: 30 days post surgery ] [ Designated as safety issue: No ]Evaluation of the number of patients who have no evidence of tumor in the resected tumor.
|Study Start Date:||July 2007|
|Study Completion Date:||October 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Experimental: Zactima, Paclitaxel, Carboplatin
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.
Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1
Other Name: Paraplatin ®Drug: paclitaxel
Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1.
Other Names:Drug: Zactima
Zactima- 100 mg orally daily, starting on day 1 of cycle 1.
Other Names:Procedure: neoadjuvant therapy
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.
Other Name: R0 Resection
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459121
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Study Chair:||Shirish M. Gadgeel, MD||Barbara Ann Karmanos Cancer Institute|