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.
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
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- 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
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
- Being tested
- carboplatin, paclitaxel, Zactima, neoadjuvant therapy
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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.
Complete Resection (R0) Rate
Measured: Following three cycles of pre-operative zactima and carboplatin/paclitaxel
Secondary outcomes (4)
Post-Operative Mortality Rate
Measured: at 30 days
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
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
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.
- First posted11 Apr 2007 (estimated)
- Study startJul 2007
- Primary completionJan 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Shirish M. Gadgeel, Barbara Ann Karmanos Cancer Institute
- Investigators
- Shirish M. Gadgeel, MD, Study chair, Barbara Ann Karmanos Cancer Institute
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00459121
- Acronym / sponsor ID
- CDR0000539273
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 11 Apr 2007 (estimated)
- Results
- Posted 7 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zactima, Paclitaxel, Carboplatin | Experimental | Drug: carboplatin, Drug: paclitaxel, Drug: Zactima, Procedure: neoadjuvant therapyZactima- 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. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboplatinAlso: Paraplatin ®Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 | Drug | Zactima, Paclitaxel, Carboplatin |
| paclitaxelAlso: Taxol ®, Onxal TMPaclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. | Drug | Zactima, Paclitaxel, Carboplatin |
| ZactimaAlso: Caprelsa, ZD6474, VandetanibZactima- 100 mg orally daily, starting on day 1 of cycle 1. | Drug | Zactima, Paclitaxel, Carboplatin |
| neoadjuvant therapyAlso: R0 ResectionNeoadjuvant 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. | Procedure or surgery | Zactima, Paclitaxel, Carboplatin |
Primary outcome
Complete Resection (R0) Rate
Time frame: Following three cycles of pre-operative zactima and carboplatin/paclitaxel
4 secondary outcomes
Post-Operative Mortality Rate
Time frame: at 30 days
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
Assess the Clinical Response Rate of the Proposed Pre-operative Regimen
Time frame: End of three cycles of treatment
Assess the Complete Pathologic Complete Response (CR) Rate With This Regimen.
Time frame: 30 days post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirish M. Gadgeel, MD study chair
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
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.