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A Randomized Study to Evaluate the Effect of Two Different Doses of Enoxaparin Sodium in Combination With Standard Chemotherapy in Patients With Stage Small Cell Lung Cancer (SCLC)
7 mei 2013 bijgewerkt door: Rachel P. Rosovsky, MD, Massachusetts General Hospital
A Randomized Phase II Study to Evaluate the Effect of Two Different Doses of Enoxaparin Sodium in Combination With Standard Chemotherapy (Cisplatin Plus Etoposide) With Respect to Time to Tumor Progression (TTP) in Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer (SCLC) Without Underlying Venous Thromboembolism
The purpose of this research study is to see if adding enoxaparin sodium to standard treatment with the chemotherapy drugs cisplatin and etoposide will help treat extensive stage SCLC.
Two different doses of enoxaparin sodium will be studied in order to determine if one dose is more effective than the other.
Enoxaparin sodium (Lovenox) is a drug that is approved by the FDA to help treat or prevent blood clots.
Results from previous research studies suggest that adding enoxaparin sodium to standard treatment improved the response to treatment for some study participants with various types of cancer.
Studie Overzicht
Toestand
Ingetrokken
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
- Since no one knows which of the study options are best, participants will be randomized into one of three study treatment groups. Group A will receive cisplatin and etoposide. Group B will receive cisplatin and etoposide plus low-dose enoxaparin sodium. Group C will receive cisplatin and etoposide plus high-dose enoxaparin sodium.
- Study treatment will be divided into chemotherapy and post-chemotherapy periods. All three groups (Group A, B and C) will receive six 3-week cycles of chemotherapy. Groups B and C will also receive daily enoxaparin sodium during the chemotherapy stage and daily enoxaparin sodium for 1 year after the chemotherapy.
- Cisplatin and etoposide are given as an infusion in 3-week cycles for up to six cycles. Enoxaparin sodium is given as an injection under the skin into the sides of the abdomen. Participants will be instructed in how to give themselves the injections.
Studietype
Ingrijpend
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Verenigde Staten, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Verenigde Staten, 02114
- Massachusetts General Hospital
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Peabody, Massachusetts, Verenigde Staten, 01970
- North Shore Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- 18 years of age or older
- Histologically or cytologically documented extensive disease small cell lung cancer. Only small cell histology is eligible. Mixed histology is not eligible. Patients who are considered to have operable disease are not eligible
- Radiographic measurable disease by RECIST criteria
- Life expectancy of greater than 4 months and ECOG Performance Status of less than or equal to 2
- Patients must be an appropriate candidate for the standard combination of cisplatin and etoposide for SCLC. There are no restrictions on radiotherapy
- No prior chemotherapy for SCLC cancer
- Participants must meet the hematological, renal and hepatic function requirements outlined in the protocol
- If brain or bone metastases are present at the time of initial diagnosis, patients must have completed radiation treatment at least 2 weeks before starting the study
- No active uncontrolled infection
- No other serious illness or medical condition that in the opinion of the investigator would be expected to interfere with the subject's ability to receive study treatment or comply with study procedures
Exclusion Criteria:
- New (defined as 6 months or less) or symptomatic thrombosis at the time of enrollment
- Indication for anticoagulant treatment such as mechanical heart valves, atrial fibrillation, or previous VTE
- Contraindication or known hypersensitivity to LMWH or unfractionated heparin (UFH)
- Active bleeding disorder
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or breast feeding women
- Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers will are eligible if diagnosed and treated within the past 5 years; cervical in situ, and basal cell or squamous cell carcinoma of the skin
- HIV-positive individuals on combination antiretroviral therapy are ineligible
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Group A
Cisplatin and Etoposide
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Etoposide given as an infusion on day 1, day 2 and day 3 of a three-week cycle for a total of 6 cycles
Given as an infusion on day 1 of a three-week cycle for a total of 6 cycles
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Experimenteel: Group B
Cisplatin and etoposide, plus low-dose enoxaparin sodium
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Etoposide given as an infusion on day 1, day 2 and day 3 of a three-week cycle for a total of 6 cycles
Given as an infusion on day 1 of a three-week cycle for a total of 6 cycles
Given as a subcutaneous injection in the abdomen daily during chemotherapy treatment and then continuing daily for 1 year.
Dose will vary.
Andere namen:
|
Experimenteel: Group C
Cisplatin and etoposide, plus high-dose enoxaparin sodium
|
Etoposide given as an infusion on day 1, day 2 and day 3 of a three-week cycle for a total of 6 cycles
Given as an infusion on day 1 of a three-week cycle for a total of 6 cycles
Given as a subcutaneous injection in the abdomen daily during chemotherapy treatment and then continuing daily for 1 year.
Dose will vary.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
To evaluate the prophylactic and treatment doses of Enoxaparin sodium given in combination with standard chemotherapy compared to standard chemotherapy alone with respect to time to tumor progression in this patient population.
Tijdsspanne: 2 years
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2 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
To determine the effect of 2 different doses of enoxaparin sodium in combination with chemotherapy and chemotherapy alone on biomarkers of angiogenesis and to identify if these markers correlate with overall survival and progression free survival.
Tijdsspanne: 2 years
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2 years
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To evaluate toxicity and determine the rates of bleeding complications in this patient population.
Tijdsspanne: 2 years
|
2 years
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Rachel Rosovsky, MD, MPH, Massachusetts General Hospital
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juli 2008
Primaire voltooiing (Verwacht)
1 juli 2010
Studieregistratiedata
Eerst ingediend
5 juni 2009
Eerst ingediend dat voldeed aan de QC-criteria
8 juni 2009
Eerst geplaatst (Schatting)
9 juni 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
8 mei 2013
Laatste update ingediend die voldeed aan QC-criteria
7 mei 2013
Laatst geverifieerd
1 juli 2010
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Neoplasmata
- Longziekten
- Neoplasmata per site
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Longneoplasmata
- Kleincellig longcarcinoom
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Fibrinolytische middelen
- Fibrine modulerende middelen
- Antineoplastische middelen
- Antineoplastische middelen, fytogeen
- Topoisomerase II-remmers
- Topoisomeraseremmers
- Anticoagulantia
- Etoposide
- Enoxaparine
- Enoxaparine natrium
Andere studie-ID-nummers
- 08-097
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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