- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00051571
Safety/Efficacy Study of Immunoconjugate With Docetaxel in Non-small Cell Lung Carcinoma
A Phase II Study Using SGN-15 (cBR96-Doxorubicin Immunoconjugate) in Combination With Docetaxel for the Treatment of Advanced Stage or Recurrent Non-Small Cell Lung Carcinoma
This randomized phase II clinical trial evaluates the combination of a monoclonal antibody-based drug (SGN-15) with a chemotherapeutic agent compared to chemotherapy given alone in patients with non-small cell lung cancer that has failed at least one prior systemic therapy. The objective of the study is to determine the safety and clinical benefit, as measured by tumor response and quality of life, to the combination regimen.
Monoclonal antibody therapy has been used in other types of cancer to target therapy to the tumor, thereby allowing for the chemotherapeutic agent to have a lesser effect on normal, healthy tissue.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
California
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Los Angeles, California, Forenede Stater, 90095
- UCLA Medical Center
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-
Connecticut
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Greenwich, Connecticut, Forenede Stater, 06830
- Bendheim Cancer Center
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Florida
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Fort Myers, Florida, Forenede Stater, 33901
- Florida Cancer Specialists
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Port St. Lucie, Florida, Forenede Stater, 34952
- Hematology Oncology Associates of the Treasure Coast
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- University of Chicago
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Oregon
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Portland, Oregon, Forenede Stater, 97213
- Providence Health System
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Portland, Oregon, Forenede Stater, 97227
- Kaiser Permanente
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Washington
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Seattle, Washington, Forenede Stater, 98101
- Virginia Mason Research Center
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Tacoma, Washington, Forenede Stater, 98431
- Madigan Army Medical Center
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
INCLUSION CRITERIA:
Patients with pathologically confirmed NSCLC which is metastatic or recurrent (non-resectable), who have failed at least one but no more than two prior therapies for advanced stage disease or have a recurrence within 6 months of completing adjuvant chemotherapy.
Lewis-y antigen expression documented by immunohistochemistry for all patients.
Patients must have:
- Bidimensionally or unidimensionally measurable disease on the basis of physical exam or imaging studies, or
- Evaluable disease: bone metastases defined on bone scan or malignant pleural effusion
Performance status ≤ 2 (ECOG scale) with a life expectancy of at least 3 months
Patients must be at least four weeks from prior treatment (chemotherapy, hormonal therapy, or definitive radiotherapy)
EXCLUSION CRITERIA:
Prior therapy with TAXOTERE (docetaxel)
Cumulative anthracycline exposure > 300 mg/m2.
More than one primary malignancy with the exception of:
- Non-melanoma skin cancer
- In situ carcinoma of the cervix
- Localized prostate cancer
- Completely resected stage I or II disease with no evidence of recurrent cancer from which the patient has remained disease free for more than 3 years.
Uncontrolled significant non-malignant disease (e.g. congestive heart failure, bleeding, renal failure, hepatic failure).
Uncontrolled, symptomatic brain metastasis.
Peripheral neuropathy > grade 2.
Concomitant therapy with other anti-neoplastic agents or experimental agents except for small volume radiation to a solitary bony metastasis.
Active viral, bacterial or systemic fungal infections including known HIV or Hepatitis B or C.
Women who are pregnant or breastfeeding
Any serious underlying medical condition, which would impair the ability of the patient to receive the planned treatment including prior allergic reactions to recombinant human or murine proteins.
Dementia or altered mental status that would prohibit the understanding and rendering of informed consent.
Patients with uncontrolled peptic ulcer disease will be excluded.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Andrew Sandler, MD, Seagen Inc.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer efter histologisk type
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer, kirtel og epitel
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Karcinom
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Docetaxel
Andre undersøgelses-id-numre
- SG0002-015
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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Australian and New Zealand Urogenital and Prostate...Peter MacCallum Cancer Centre, AustraliaRekrutteringKastrationsresistent prostatakræftAustralien
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SanofiAfsluttet
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