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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)

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

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)



- 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


- 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.

Inclusion Criteria


- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting
1 of the following staging criteria:

- Stage IB or II disease

- T3, N0-1 disease (stage IIIA)

- Deemed a surgical candidate

- No prior lung cancer (NSCLC or small cell lung cancer)


- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

- WBC ≥ 3,000/mm³

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Bilirubin normal

- AST and ALT ≤ 2.5 times upper limit of normal (ULN)

- Creatinine ≤ 1.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No evidence of severe or uncontrolled systemic disease or any concurrent condition
that, in the opinion of the investigator, would preclude study compliance

- No peripheral neuropathy ≥ grade 2

- No hemoptysis within the past 12 weeks

- No spontaneous bleeding within the past 12 weeks

- No clinically significant cardiac event (e.g., NYHA class II-IV heart disease,
myocardial infarction) within the past 3 months

- No history of asymptomatic sustained ventricular tachycardia or arrhythmia that is
symptomatic or requires treatment, including any of the following:

- Multifocal premature ventricular contractions

- Bigeminy

- Trigeminy

- Ventricular tachycardia

- Uncontrolled atrial fibrillation

- Atrial fibrillation controlled with medication allowed

- No history of QTc prolongation as a result from other medication that required
discontinuation of that medication

- No congenital long QT syndrome or first-degree family relative with an unexplained
death before the age of 40

- No left bundle branch block

- No QTc with Bazett's correction that is unmeasurable or QTc ≥ 480 milliseconds on
screening ECG

- Patients with QTc ≥ 480 milliseconds on screening ECG may have ECG repeated

- Average QTc from the 3 screening ECG's must be < 480 milliseconds

- No uncontrolled hypertension (systolic BP > 160 mm Hg or diastolic BP > 100 mm Hg)

- No active diarrhea or active gastrointestinal disease that may affect the absorption
of study drugs or ability to tolerate study drugs

- No other malignancy within the past 3 years except in situ cervical carcinoma or
adequately treated basal cell or squamous cell carcinoma of the skin


- More than 4 weeks since major surgery and recovered

- No prior carboplatin, paclitaxel, or vandetanib

- More than 30 days since prior investigational agents

- More than 2 weeks since prior and no concurrent drugs that induce CYP3A4 including,
but not limited to, any of the following:

- Rifampin

- Phenytoin

- Carbamazepine

- Barbiturates

- Hypericum perforatum (St. John's wort)

- No medication that may cause QTc prolongation or induce torsades de pointes for 2
weeks prior to beginning study treatment, during, and for 2 weeks after completion of
study treatment

- No concurrent combination antiretroviral treatment for HIV-positive patients

- No other concurrent investigational agents

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete Resection (R0) Rate

Outcome Time Frame:

Following three cycles of pre-operative zactima and carboplatin/paclitaxel

Safety Issue:


Principal Investigator

Shirish M. Gadgeel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

July 2007

Completion Date:

October 2008

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201