- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00104728
Neoadjuvant IRESSA As Single Agent PreopTherapy for NSCLC With Molecular Correlates
Pilot Neoadjuvant Study of ZD1839 (IRESSA®) as Single Agent Preoperative Therapy for Clinical Stage 1A and 1B (T1-2N0), II (T1-2N1, T3N0) and Selected IIIA (T3N1) Non-Small Cell Lung Cancer (NSCLC) With Molecular Correlates
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gefitinib before surgery may shrink the tumor so it can be removed.
PURPOSE: This phase II trial is studying how well gefitinib works in treating patients who are undergoing surgery for stage I, stage II, or stage III non-small cell lung cancer.
Panoramica dello studio
Descrizione dettagliata
OBJECTIVES:
Primary
- Determine the effects of neoadjuvant gefitinib on downstream signaling pathways, including Src-Stat3, PI3K/Akt, ERK activity, and Bcl-2 family members in patients with resectable stage I-IIIA non-small cell lung cancer.
- Determine the effects of this drug on cell cycle and apoptosis within the primary tumor, by measuring changes in pre- and post-treatment Ki-67, Mcm2, cleaved caspase-3, and ApoTag, in these patients.
Secondary
- Determine the clinical response rate in patients treated with this drug.
- Determine the pathological response rate, defined as > 95% necrosis or fibrosis in the pathological specimen, in patients treated with this drug.
- Determine the metabolic activity of this drug in these patients.
- Determine the safety, tolerability, and feasibility of this drug, in terms of toxicity and post-treatment resectability, in these patients.
- Correlate plasma and tumor concentrations of this drug with changes in post-treatment molecular markers in these patients.
- Identify a gene profile that predicts response to this drug in these patients.
OUTLINE: This is an open-label, pilot study.
Patients receive oral gefitinib once daily for 4 weeks in the absence of disease progression or unacceptable toxicity.
Within 3 days after completion of gefitinib, patients undergo restaging evaluation. Patients whose disease is still considered resectable proceed to surgery. Patients undergo thoracotomy with lobectomy or pneumonectomy OR sleeve resection. Patients also undergo mediastinal lymph node dissection. After surgical resection, treatment with gefitinib may continue off study at the discretion of the principal investigator.
After completion of study therapy, patients are followed at 30 days, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 12.5 months.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Florida
-
Tampa, Florida, Stati Uniti, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS:
Histologically confirmed resectable non-small cell lung cancer (NSCLC), meeting 1 of the following clinical staging criteria:
- Stage IA or IB (T1-2, N0)
- Stage II (T1-2, N1 with negative mediastinoscopy or T3, N0)
Stage IIIA (T3, N1 with negative mediastinoscopy)
- Level 10 hilar nodes may be positive provided mediastinoscopy is negative
The following are not allowed (as evidenced by clinical staging criteria [CT scan, positron-emission tomography (PET) scan, or mediastinoscopy):
- Positive N2 lymph nodes (ipsilateral/subcarinal mediastinal lymph nodes)
- Positive N3 lymph nodes (contralateral mediastinal/hilar and supraclavicular/scalene lymph nodes)
- T4 primary tumor (malignant pleural effusion or mediastinal invasion)
- Symptomatic tumors (T3, N0-1) involving the superior sulcus (i.e., Pancoast tumors)
- Measurable disease by contrast-enhanced CT scan
- No metastatic disease (except peribronchial or hilar lymph node involvement [N1]) by fludeoxyglucose F 18 PET scan
No malignant pleural effusion by preoperative evaluation
- Pleural effusions visible only on CT scan that are not large enough for safe thoracentesis are allowed
No exudative effusions (even if cytologically negative), as evidenced by any of the following:
- Ratio of pleural fluid protein to serum protein > 0.5
- Ratio of pleural fluid lactic dehydrogenase (LDH) to serum LDH ≥ 0.6
- Pleural fluid LDH > 200 IU/L
- No superior vena cava syndrome
- No spinal cord compression
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Eastern Cooperative Oncology Group (ECOG) 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC ≥ 4,000/mm^3
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT ≤ 2 times ULN
- Alkaline phosphatase ≤ 2 times ULN
Renal
- Creatinine < 1.5 times ULN
Cardiovascular
- No uncontrolled ventricular arrhythmia
- No myocardial infarction within the past 3 months
Pulmonary
- Pre-resection FEV_1 > 2.0 L OR
- Predicted post-resection FEV_1 > 1.0 L
No clinically active interstitial lung disease
- Chronic stable asymptomatic radiographic changes allowed
- No post-obstructive pneumonia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Willing to provide tumor biopsy pre- and post-gefitinib administration AND undergo PET scan
- No known severe hypersensitivity to study drug or any of its excipients
- No uncontrolled major seizure disorder
- No unstable or uncontrolled diabetes mellitus
- No serious infection requiring IV antibiotics
- No grade 3 neuropathy
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No other unstable or serious medical condition that would preclude study treatment or surgery
- No psychiatric disorder that would preclude giving informed consent
- No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow up
- No other significant clinical disorder or laboratory finding that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior or concurrent systemic chemotherapy for NSCLC
Endocrine therapy
- Not specified
Radiotherapy
- No prior or concurrent radiotherapy for NSCLC
Surgery
- Recovered from prior oncologic or other major surgery
- At least 5 years since prior resection of lung disease
- No prior surgery for NSCLC
- No concurrent ophthalmic surgery
Other
- More than 30 days since prior non-approved or investigational drugs
- No other concurrent therapy for NSCLC
- No other concurrent investigational therapy
No concurrent use of any of the following medications:
- Phenytoin
- Carbamazepine
- Barbiturates (e.g., phenobarbital)
- Rifampin
- Hypericum perforatum (St. John's wort)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Neoadjuvant ZD1839 Preoperative Therapy
The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food. At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth. |
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Overall Response Rate (ORR)
Lasso di tempo: 3 years
|
Objective Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Investigators planned to use this pilot study of neoadjuvant ZD1839 in patients with resectable NSCLC to specifically correlate molecular parameters to the primary clinical study endpoint clinical response assessed by CT response and PET scan response of the primary tumor.
|
3 years
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Frequency of Toxicity Related to Study Treatment
Lasso di tempo: 3 years
|
Review of adverse events utilizing Common Toxicity Criteria (CTC) V3.
To estimate the safety, tolerability, and feasibility of preoperative ZD1839 in patients with resectable Stage IA/IB, II and selected IIIA NSCLC by evaluating toxicity and operability after preoperative ZD1839.
|
3 years
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Eric B. Haura, M.D., H. Lee Moffitt Cancer Center and Research Institute
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MCC-13922
- IRUSIRES0256 (Altro identificatore: AstraZeneca)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cancro ai polmoni
-
National Cancer Institute (NCI)ReclutamentoKita-kyushu Lung Cancer Antigen 1, umanoStati Uniti
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletatoAdenocarcinoma dell'intestino tenue | Adenocarcinoma dell'intestino tenue in stadio III AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIA AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIB AJCC v8 | Adenocarcinoma dell'intestino tenue stadio IV AJCC v8 | Ampolla di Vater... e altre condizioniStati Uniti
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...CompletatoStudio delle donne cinesi che non hanno aderito alle linee guida per lo screening mammografico dell'American Cancer SocietyStati Uniti
-
Novartis PharmaceuticalsAttivo, non reclutanteEGFR mutante avanzato Non SmallSellLung Cancer (NSCLC), KRAS G12-mutant NSCLC, Esophageal SquamousCell Cancer (SCC), Head/Neck SCC, MelanomaTaiwan, Stati Uniti, Olanda, Spagna, Corea, Repubblica di, Italia, Giappone, Canada, Singapore
-
Emory UniversityNational Cancer Institute (NCI)RitiratoCancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
NRG OncologyNational Cancer Institute (NCI)Attivo, non reclutanteCancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioniStati Uniti, Canada, Arabia Saudita, Corea, Repubblica di
-
Jonsson Comprehensive Cancer CenterNon ancora reclutamentoCarcinoma della prostata | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Rashmi Verma, MDNational Cancer Institute (NCI)ReclutamentoCarcinoma prostatico resistente alla castrazione | Adenocarcinoma prostatico metastatico | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Assiut UniversityNon ancora reclutamentoDeterminare l’incidenza cumulativa di AKI utilizzando i criteri KDIGO in pazienti pediatrici con tumori maligni presso il South Egypt Cancer Institute (SECI)
-
University of ChicagoNational Cancer Institute (NCI)CompletatoAdenocarcinoma pancreatico | Adenocarcinoma gastrico | Adenocarcinoma pancreatico metastatico | Neoplasia gastrointestinale maligna | Cancro al pancreas in stadio III | Cancro al pancreas in stadio IV | Carcinoma della cistifellea | Cancro alla cistifellea in stadio IV | Cancro gastrico in stadio IV | Cancro... e altre condizioniStati Uniti
Prove cliniche su ZD1839
-
NSABP Foundation IncAstraZenecaCompletatoNeoplasie mammarieStati Uniti
-
Indiana University School of MedicineAstraZenecaTerminatoTumori a cellule germinali refrattari che esprimono EGRFStati Uniti
-
AstraZenecaCompletato
-
University of ChicagoCompletato
-
M.D. Anderson Cancer CenterAstraZenecaCompletatoCancro della pelleStati Uniti
-
AstraZenecaRitirato
-
SCRI Development Innovations, LLCAstraZenecaCompletato
-
Genzyme, a Sanofi CompanyCompletatoCarcinoma, polmone non a piccole celluleStati Uniti, Sud Africa, Regno Unito, Germania, Argentina, Belgio
-
M.D. Anderson Cancer CenterAstraZenecaCompletatoCancro delle ghiandole salivariStati Uniti