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)
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Complete Resection (R0) Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: carboplatin (Drug)
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.
Intervention: paclitaxel (Drug)
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.
Intervention: Zactima (Drug)
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.
Intervention: neoadjuvant therapy (Procedure)
Outcomes
Primary Outcomes
Complete Resection (R0) Rate
Time Frame: Following three cycles of pre-operative zactima and carboplatin/paclitaxel
Secondary Outcomes
- Post-Operative Mortality Rate(at 30 days)
- Assess Toxicity of This Regimen and the Percentage of Patients Completing All Planned Cycles of Therapy(Weekly for the first cycle; Thereafter within 72 hours of each dose of carboplatin/paclitaxel)
- Assess the Clinical Response Rate of the Proposed Pre-operative Regimen(End of three cycles of treatment)
- Assess the Complete Pathologic Complete Response (CR) Rate With This Regimen.(30 days post surgery)
Investigators
Shirish M. Gadgeel
Principal Investigator
Barbara Ann Karmanos Cancer Institute