Lung Cancer Clinical Trial
Official title:
A Randomized Phase II Study Evaluating Vandetanib (ZD6474) in Combination With Docetaxel and Carboplatin Followed by Placebo or Maintenance Therapy With Vandetanib in Patients With IIIb, IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Verified date | April 2018 |
Source | PrECOG, LLC. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
It has been shown in previous studies that the ability to treat lung cancer could be
significantly improved by not only targeting the tumor cells directly with chemotherapy, but
also by cutting off the blood supply to the cancer cells. Blood vessels that supply the tumor
are formed through a process called angiogenesis. Vandetanib is an investigational drug that
acts by producing what is called an anti-angiogenic effect. An Anti-angiogenic effect is able
to inhibit the development of new blood vessels required by tumors to survive by blocking the
growth factors needed to form new blood vessels.
The purpose of this study is to determine if the addition of vandetanib to a standard
chemotherapy regimen will slow or stop the growth of the cancer for a longer period of time
compared to the time period generally gained from the use of standard chemotherapy alone
Status | Completed |
Enrollment | 162 |
Est. completion date | April 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically or cytologically confirmed non-small cell lung cancer - Advanced disease (stage IIIB disease [malignant pleural or pericardial effusion seen on CT or Chest X-ray, any N, M0] or stage IV disease [Any T, any N, M1: distant metastases]) that is primary or recurrent - Measurable disease according to the RECIST criteria - ECOG Performance Status 0 or 1 - Adequate organ function, as evidenced by ALL the following - Absolute neutrophil count (ANC) = 1500/mm³ and platelet count = 100,000/mm³ - Hemoglobin = 9 gm/dL - Total bilirubin = 1 X institutional ULN; if patient has Gilbert's disease, then patient must have isolated hyperbilirubinemia (e.g. no other liver function test abnormality), with maximum bilirubin = 2 X institutional ULN. - AST, ALT and alkaline phosphatase (Alk Phos) must be = 1.5 ULN - Creatinine = 1.5 X institutional ULN or calculated creatinine clearance = 60 ml/min - Potassium between 4 mEq/L and institutional ULN (supplementation may be used), - Calcium (ionized or adjusted for albumin)within institutional normal limits - Magnesium within institutional normal limits (supplementation may be used) - No prior cytotoxic chemotherapy or targeted therapy for advanced or metastatic disease (Prior adjuvant therapy for lung cancer allowed if completed > 1 year prior to registration) - Able to take oral medication Exclusion Criteria: - Myocardial infarction, superior vena caval syndrome, NYHA classification of heart disease = 2 within the 3 months prior to entry - History of an uncontrolled or recurrent ventricular, supraventricular or nodal arrhythmia that requires treatment - Hypertension not controlled by medication - Peripheral or sensory neuropathy > grade 1 - Known hypersensitivity to carboplatin or docetaxel - Active infection |
Country | Name | City | State |
---|---|---|---|
United States | Abington Memorial Hospital | Abington | Pennsylvania |
United States | St. Joseph Mercy Hospital- Ann Arbor | Ann Arbor | Michigan |
United States | Greater Baltimore Medical Center | Baltimore | Maryland |
United States | Boca Raton Community Hospital | Boca Raton | Florida |
United States | Ocean Medical Center | Brick | New Jersey |
United States | Montefiore Medical Center | Bronx | New York |
United States | Aultman Hospital | Canton | Ohio |
United States | Charleston Area Medical Center | Charleston | West Virginia |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Hematology & Oncology of NEPA | Dunmore | Pennsylvania |
United States | St. Vincent Hospital | Green Bay | Wisconsin |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Gundersen Lutheran | La Crosse | Wisconsin |
United States | Lakeland Regional Cancer Center | Lakeland | Florida |
United States | Lancaster General Hospital | Lancaster | Pennsylvania |
United States | Central PA Hematology & Medical Oncology Associaties | Lemoyne | Pennsylvania |
United States | Morristown Memorial Hospital | Morristown | New Jersey |
United States | Meharry Medical College | Nashville | Tennessee |
United States | Cancer Institute of New Jersey | New Brunswick | New Jersey |
United States | Ochsner Clinic | New Orleans | Louisiana |
United States | Albert Einstein Cancer Center | Philadelphia | Pennsylvania |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | The Reading Hospital and Medical Center | Reading | Pennsylvania |
United States | Riverview Medical Center | Red Bank | New Jersey |
United States | SwedishAmerican Hospital | Rockford | Illinois |
United States | Metro-Minnesota CCOP | Saint Louis Park | Minnesota |
United States | Sanford Clinic | Sioux Falls | South Dakota |
United States | Mount Nittany Medical Center | State College | Pennsylvania |
United States | Regional Cancer Center | Waukesha | Wisconsin |
United States | Cancer Center of Kansas | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
PrECOG, LLC. | AstraZeneca |
United States,
Aisner J, Manola JB, Dakhil SR, Stella PJ, Sovak MA, Schiller JH. Vandetanib plus chemotherapy for induction followed by vandetanib or placebo as maintenance for patients with advanced non-small-cell lung cancer: a randomized phase 2 PrECOG study (PrE0501 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free Survival | Time from randomization (prior to induction) to first evidence of disease progression or death without progression. Participants alive without progression were censored at the date of last disease evaluation. | Assessed every 2 cycles (1 cycle = 3 weeks during induction and 4 weeks during maintenance)) | |
Secondary | Objective Response Rate | Best overall response (complete or partial response), assessed using RECIST criteria (version 1.0) | Assessed every 2 cycles (1 cycle = 3 weeks during induction and 4 weeks during maintenance)) | |
Secondary | Progression-free Survival | Time from randomization to first evidence of disease progression or death. Patients alive without progression are censored at the date of last disease evaluation. | every 2 cycles (every 6 weeks during induction, every 8 weeks during maintenance) |
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 |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
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 | |
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
|