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

NCT00459121 | Terminated Phase 2 Results DMC

• 6 other identifiers: CDR0000539273P30CA022453WSU-2006-122WSU-011807MP2FWSU-0612004427ZENECA-IRUSZACT0029
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Complete Resection (R0) Rate

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

Secondary Outcomes (4)

• 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

Study Arms (1)

Zactima, Paclitaxel, Carboplatin

EXPERIMENTAL

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.

Drug: carboplatin; Drug: paclitaxel; Drug: Zactima; Procedure: neoadjuvant therapy

Interventions

carboplatin DRUG

Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1

Also known as: Paraplatin ®

Zactima, Paclitaxel, Carboplatin

paclitaxel DRUG

Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1.

Also known as: Taxol ®, Onxal TM

Zactima, Paclitaxel, Carboplatin

Zactima DRUG

Zactima- 100 mg orally daily, starting on day 1 of cycle 1.

Also known as: Caprelsa, ZD6474, Vandetanib

Zactima, Paclitaxel, Carboplatin

neoadjuvant therapy PROCEDURE

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.

Also known as: R0 Resection

Zactima, Paclitaxel, Carboplatin

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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) PATIENT CHARACTERISTICS: * 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 twice * 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 PRIOR CONCURRENT THERAPY: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Paclitaxel; vandetanib; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Combined Modality Therapy; Therapeutics

Limitations and Caveats

This was a single center study. We did not accrue enough particpants in a timely fashion and a joint decision was made with AstraZeneca to terminate the study.

Results Point of Contact

• Title: Shirish Gadgeel, M.D.
• Organization: Barbara Ann Karmanos Cancer Institute

sgadgeel@med.umich.edu

313-576-8753

Study Officials

• Shirish M. Gadgeel, MD

  Barbara Ann Karmanos Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2007
• First Posted: April 11, 2007
• Study Start: July 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: October 1, 2008
• Last Updated: March 26, 2019
• Results First Posted: December 7, 2012

Record last verified: 2013-02

Locations

US (1)