Lung Cancer Clinical Trial
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)
Verified date | February 2013 |
Source | Barbara Ann Karmanos Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | October 2008 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Barbara Ann Karmanos Cancer Institute | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Resection (R0) Rate | Following three cycles of pre-operative zactima and carboplatin/paclitaxel | ||
Secondary | Post-Operative Mortality Rate | at 30 days | ||
Secondary | 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. | Weekly for the first cycle; Thereafter within 72 hours of each dose of carboplatin/paclitaxel | |
Secondary | 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 | End of three cycles of treatment | |
Secondary | 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. | 30 days post surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03918538 -
A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors
|
N/A | |
Recruiting |
NCT05078918 -
Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors
|
N/A | |
Active, not recruiting |
NCT04548830 -
Safety of Lung Cryobiopsy in People With Cancer
|
Phase 2 | |
Completed |
NCT04633850 -
Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
|
||
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05583916 -
Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery
|
N/A | |
Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Not yet recruiting |
NCT06376253 -
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
|
Phase 1 | |
Recruiting |
NCT05898594 -
Lung Cancer Screening in High-risk Black Women
|
N/A | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03575793 -
A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
Terminated |
NCT01624090 -
Mithramycin for Lung, Esophagus, and Other Chest Cancers
|
Phase 2 | |
Terminated |
NCT03275688 -
NanoSpectrometer Biomarker Discovery and Confirmation Study
|
||
Not yet recruiting |
NCT04931420 -
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
|
Phase 2 | |
Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06052449 -
Assessing Social Determinants of Health to Increase Cancer Screening
|
N/A | |
Not yet recruiting |
NCT06017271 -
Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
|
||
Recruiting |
NCT05787522 -
Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
|