Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed Versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer Other Than Predominantly Squamous Cell Histology

CompletadoFase 3ClinicalTrials.gov

ID: NCT00686959Tipo: INTERVENTIONALInicio: 1 de sept de 2008Fin estimado: 1 de nov de 2014

Traducción no disponible, mostrando original

Resumen

This study will compare the overall survival of participants with locally-advanced, Stage III Non-Small Cell Lung Cancer (NSCLC) with nonsquamous cell histology.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants must have Stage IIIA or IIIIB NSCLC of the non-squamous type
Participants must have measureable tumor lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated on computerized tomography (CT) scan
Participants must be physically mobile, take care of themselves and must be up and about and able to perform light activities, such as light housework or office work
Participants must be 18 years of age or older
Participants must have lost no more than 10% of their body weight in the previous 3 months
Women must be sterile, postmenopausal, or on contraception, and men must be sterile or on contraception
Participants' test results assessing the function of their blood forming tissue, kidneys, liver, and lungs must be satisfactory
Participants with Stage IIIB NSCLC who have supraclavicular nodal involvement may be entered into this study. However, participants with cervical nodes are not permitted. The upper border of supraclavicular nodes must not extend above the upper border of the lateral end of the clavicle, extended medially.

Criterios de exclusión

Participants cannot have other on-going (uncontrolled) illnesses, including active infections, recent heart problems, or psychiatric illnesses
Participants who are unable to take vitamins (including injections of vitamin B12) or oral cortisone medication
Participants who have had a heart attack (myocardial infarction) or other cardiac issues within 6 months of the trial
Participants who have received other investigational drugs within the last 30 days
Participants who are unable to stop taking more than 1.3 grams of aspirin on a daily basis or non-steroidal anti-inflammatory agents
Participants who have diseases considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumors
Participants who had prior thoracic radiation. However, other prior radiotherapy is allowed. Participants must have recovered from the toxic effects of the treatment prior to study enrollment. Participants may not have received whole pelvis radiation or radiation to more than 25% of their bone marrow. Prior radiotherapy must have been completed at least 30 days prior to study treatment.
Participants who have a radiation treatment plan that would expose more than 35% of the volume of their lung to 20 gray (Gy) or more of radiation
Participants who have concurrent cancer from another primary site requiring treatment of any kind within the past 5 years. Exemptions to this will be permitted on a case-by-case basis after prior approval by the Sponsor physician or designate if the investigator believes the participant's risk of recurrence and death is very low. Curatively treated nonmelanoma skin cancer or in situ carcinoma of any origin is allowed. Participants with recurrence of a previously resected lung cancer or who have a second primary lung cancer are ineligible.

Intervenciones

drug

Pemetrexed

infusion over 10 minutes

drug

Cisplatin

infusion over 60 minutes with adequate anti-emetic treatment and appropriate hydration per local practice guidelines

drug

Etoposide

administered per local practice guidelines over a minimum of 30 minutes

drug

Vinorelbine

administered over 6-10 minutes infusion per local practice guidelines

drug

Paclitaxel

administered as a 3-hour infusion

drug

Carboplatin

administered per local practice guidelines over 30 minutes

radiation

Thoracic Radiation Therapy (TRT)

Ubicaciones

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Buenos Aires, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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