Non-Small Cell Lung Cancer Clinical Trial
— CAPPA-2Official title:
Gemcitabine Versus Cisplatin and Gemcitabine in First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer in Poor Physical Condition (Performance Status 2)
Verified date | March 2017 |
Source | National Cancer Institute, Naples |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study is to evaluate the impact on overall survival (OS) of the addition of cisplatin to gemcitabine vs gemcitabine alone in patients with advanced NSCLC in poor clinical condition (PS 2), not previously treated.
Status | Terminated |
Enrollment | 57 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of advanced non small cell lung cancer, not amenable to surgical or curative radiation therapy (stage IIIB or IV); - No prior or concomitant chemotherapy (adjuvant/neoadjuvant chemotherapy permitted if concluded at least one year prior to enrollment); - ECOG performance status 2; - Age: > or = 18 and < 70 years; - Life expectancy at least 4 weeks; - Normal bone marrow, hepatic and renal function defined as: neutrophils > or = 2000/mm3, PLT > or = 100,000/mm3, Hb > or = 10.0 g/dl, Bilirubin > or = 1.5 times the upper normal limit (UNL), AST and ALT < or = 3 times the UNL (5 times in the presence of liver metastases), creatinine within normal limits; - Signed informed consent. Exclusion Criteria: - Active systemic infections; - Severe concomitant illness (congestive heart failure, angina pectoris, myocardial infarction within previous 6 months, cardiac arrhythmias under treatment, severe arterial hypertension, severe or uncontrolled diabetes mellitus); - Inadequate hepatic or renal function; - Radiation therapy ongoing or concluded within two weeks prior to enrollment; - Symptomatic cerebral metastases; - Previous chemotherapy for advanced disease; - Any condition that would, in the investigator's opinion, limit the patients ability to provide informed consent or to comply with study procedures; - Pregnant or nursing females; - Any malignancy within the past 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer) |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica | Acquaviva delle Fonti | BA |
Italy | Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale | Bari | BA |
Italy | Ospedale Senatore Antonio Perrino | Brindisi | |
Italy | A.O. Ospedale Mater Domini, Oncoematologia Università Magna Grecia | Catanzaro | |
Italy | Ospedale F. Veneziale | Isernia | |
Italy | A.O. Vito Fazzi | Lecce | |
Italy | Azienda Ospedaliera C. Poma | Mantova | MN |
Italy | Istituto Scientifico S. Raffaele | Milano | MI |
Italy | Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica | Monteforte Irpino | AV |
Italy | Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B | Napoli | |
Italy | Istituto Oncologico Veneto | Padova | PD |
Italy | Ospedale Regional, Unità Operative di Oncologia | Parma | |
Italy | Ospedale San Camillo - Forlanini | Rome | |
Italy | Ospedale S. Felice a Cancello | San Felice a Cancello | |
Italy | Ospedale E. Morelli | Sondalo | SO |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute, Naples | Clinical Trials Promoting Group (APRIC/CTPG), Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente, Gruppo Oncologico del Lazio (GOL), Gruppo Oncologico Italia Meridionale, Gruppo Oncologico Italiano di Ricerca Clinica(GOIRC), Northwest Oncology Cooperative Group(GONO) |
Italy,
Morabito A, Gebbia V, Di Maio M, Cinieri S, Viganò MG, Bianco R, Barbera S, Cavanna L, De Marinis F, Montesarchio V, Costanzo R, Sandomenico C, Montanino A, Mancuso G, Russo P, Nacci A, Giordano P, Daniele G, Piccirillo MC, Rocco G, Gridelli C, Gallo C, P — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | overall survival | one year | ||
Secondary | change in performance status | each cycle of chemotherapy | ||
Secondary | toxicity | each cycle of chemotherapy and every 3 months thereafter | ||
Secondary | quality of life | chemotherapy cycles 1 and 2 | ||
Secondary | objective response | at 6 weeks and 12 weeks | ||
Secondary | progression free survival | one year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03087448 -
Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1 | |
Recruiting |
NCT05042375 -
A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Terminated |
NCT05414123 -
A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
|
||
Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
Recruiting |
NCT05919537 -
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
|
Phase 1 | |
Recruiting |
NCT05009836 -
Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
|
Phase 3 | |
Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03219970 -
Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
|
||
Recruiting |
NCT05949619 -
A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04054531 -
Study of KN046 With Chemotherapy in First Line Advanced NSCLC
|
Phase 2 | |
Withdrawn |
NCT03519958 -
Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
|
||
Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
Terminated |
NCT02580708 -
Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01871805 -
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1/Phase 2 | |
Terminated |
NCT04042480 -
A Study of SGN-CD228A in Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05919641 -
LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
|
||
Completed |
NCT03656705 -
CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma
|
Phase 1 |