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Lung CancerPhase 2NCT00459121

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

A Phase 2 study testing carboplatin, paclitaxel and Zactima in people with Lung Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Lung Cancer
What is being tested?
carboplatin, paclitaxel and Zactima
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
Jul 2007to Oct 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

Other trials in United States

About this study

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)

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.

Read the 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.

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
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • carboplatinDrug

    Also called Paraplatin ®

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

  • paclitaxelDrug

    Also called Taxol ®, Onxal TM

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

  • ZactimaDrug

    Also called Caprelsa, ZD6474, Vandetanib

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

  • neoadjuvant therapyProcedure or surgery

    Also called R0 Resection

    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.

Study groups in NCT00459121
Study groupRoleWhat they receive
Zactima, Paclitaxel, CarboplatinExperimentalZactima- 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.
Receives: Drug: carboplatin; Drug: paclitaxel; Drug: Zactima; Procedure: neoadjuvant therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Resection (R0) Rate

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

Secondary outcomes (4)
  1. Post-Operative Mortality Rate

    Measured: at 30 days

  2. Assess Toxicity of This Regimen and the Percentage of Patients Completing All Planned Cycles of Therapy

    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.

    Measured: Weekly for the first cycle; Thereafter within 72 hours of each dose of carboplatin/paclitaxel

  3. Assess the Clinical Response Rate of the Proposed Pre-operative Regimen

    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

    Measured: End of three cycles of treatment

  4. Assess the Complete Pathologic Complete Response (CR) Rate With This Regimen.

    Evaluation of the number of patients who have no evidence of tumor in the resected tumor.

    Measured: 30 days post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionJan 2008
  4. Study completionOct 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00459121
Sponsor's protocol ID
CDR0000539273
Other IDs
P30CA022453, WSU-2006-122, WSU-011807MP2F, WSU-0612004427, ZENECA-IRUSZACT0029
Status last verified
Feb 2013
First submitted
9 Apr 2007
Last updated
26 Mar 2019
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin, paclitaxel and Zactima in people with Lung Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Resection (R0) Rate (time frame: Following three cycles of pre-operative zactima and carboplatin/paclitaxel). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.

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