- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00217282
Study of Oxaliplatin and Gemcitabine With or Without Bevacizumab to Treat Advanced Non-Small Cell Lung Cancer
Phase II Trial OF Oxaliplatin and Gemcitabine With Bevacizumab in Advanced Non-Small Cell Lung Cancer
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
STUDY OBJECTIVES:
Primary:
To determine the overall time to progression of the combination regimen of Gemcitabine, Oxaliplatin and Bevacizumab as first-line treatment in patients with Stage IIIB and IV non-small cell lung cancer.
Secondary
- To determine the overall response rate
- To determine the overall survival.
- To determine the toxicity of Gemcitabine, Oxaliplatin given in combination with Bevacizumab
ELIGIBILITY CRITERIA
- Patients must have histologically or cytologically confirmed non-small cell lung cancer EXCEPT squamous cell carcinoma. Mixed tumors will be categorized by the predominant cell type unless small cell elements are present in which case the patient is ineligible. Cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy.
- Patients must have advanced NSCLC (Stage IIIB with malignant pleural effusion or Stage IV or recurrent disease).
- Patients must have measurable disease (as defined in Section 13.0).
- ECOG performance status 0 or 1.
- Patients must not have known CNS metastases. Brain imaging is required within 4 weeks prior to study entry.
- No prior systemic treatment for advanced NSCLC is permitted. Prior treatment for early-stage disease (adjuvant) or for locally-advanced Stage III disease is allowed if completed at least 12 months prior to registration.
Required laboratory values (obtained 2 weeks prior to registration):
7.1 ANC > 1500/mm³. 7.2 Platelets > 100,000/mm³. 7.3 Total Bilirubin < 1.5 mg/dl. 7.4 Transaminases < 5 x ULN.
Patients must have adequate renal function as determined by the following tests within 2 weeks prior to registration.
8.1 Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN), AND Urinalysis < 1+ protein*
* Patients discovered to have >1+ proteinuria at baseline must undergo a 24-hour urine collection. This must be an adequate collection and must demonstrate <1g of protein/24 hr to allow participation in the study.
- Patients must be 18 years or older.
- Pregnant and lactating women are excluded from the study because the agents used in this study may be teratogenic to a fetus and there is no information on the excretion of the agents or their metabolites into breast milk. A negative urine or serum pregnancy test required for women of childbearing potential.
- Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study.
- Patients treated with radiation therapy must have adverse events from therapy resolved to grade 2 or less following completion of treatment.
- Patients must not have ongoing or active infection, symptomatic congestive heart failure, cerebrovascular accident within 12 months, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients must have no deep vein thrombosis or pulmonary embolus within one year of registration and no ongoing need for full-dose oral or parenteral anticoagulation. Low dose coumadin (1mg) for maintenance of catheter patency or daily prophylactic aspirin is allowed.
- Patients with history of hypertension must be well-controlled (defined as a blood pressure of >160 mmHg systolic and/or > 110 mmHg diastolic) on a stable regimen of anti-hypertensive therapy.
- Patients must not have serious non-healing wound ulcer, or bone fracture, or major surgical procedure within 3 weeks prior to starting treatment.
- Patients with a history of gross hemoptysis (defined as bright red blood of a ½ teaspoon or more) will be excluded from this trial
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years
TREATMENT PLAN Gemcitabine 1000mg/m2 IV over 30 minutes, on days 1 and 8 followed by Oxaliplatin 130mg/m2 IV over 2 hours on day 1 followed by Bevacizumab 15 mg/kg IV over 90* minutes, on day 1 Cycles q 3 weeks x 4 cycles One cycle equals 3 weeks. Patients will be re-evaluated every 2 cycles. If CR, PR or SD, patients will continue treatment up to four cycles or until progression or unacceptable toxicity.
Patients achieving CR, PR, or SD after 4 cycles will continue Bevacizumab maintenance:
Bevacizumab 15 mg/kg IV q 3 weeks until relapse/progression
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Florida
-
Miami Beach, Florida, Forente stater, 33140
- Mount Sinai Medical Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Confirmed non-small cell lung cancer, EXCEPT squamous cell cancer
- Stage IIIB or IV disease
- ECOG PS 0-1
- No prior treatment
- No brain metastases
- Must have measurable disease
Exclusion Criteria:
- Deep vein thromboses or pulmonary embolus within 1 year
- History of gross hemoptysis
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To determine the overall time to progression of the combination regimen of Gemcitabine, Oxaliplatin and Bevacizumab as first-line treatment in patients with Stage IIIB and IV non-small cell lung cancer.
Tidsramme: Prospective
|
Prospective
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
• To determine the overall response rate • To determine the overall survival. • To determine the toxicity of Gemcitabine, Oxaliplatin given in combination with Bevacizumab
Tidsramme: Prospective
|
Prospective
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Rogerio Lilenbaum, Icahn School of Medicine at Mount Sinai
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Neoplasmer
- Lungesykdommer
- Neoplasmer etter nettsted
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karsinom, ikke-småcellet lunge
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, immunologiske
- Angiogenese-hemmere
- Angiogenesemodulerende midler
- Vekststoffer
- Veksthemmere
- Gemcitabin
- Oksaliplatin
- Bevacizumab
Andre studie-ID-numre
- LUN08
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