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- Klinische proef NCT00276588
Gemcitabine and Carboplatin Followed by Paclitaxel in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Phase II Trial of Gemcitabine/Paraplatin® (Carboplatin) Followed by Taxol® (Paclitaxel) in Patients With Performance Status = 2,3 or Other Significant Co-Morbidity (HIV Infection or s/p Organ Transplantation) in Advanced Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with carboplatin followed by paclitaxel works in treating patients with stage III or stage IV non-small cell lung cancer.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
OBJECTIVES:
Primary
- Determine the efficacy and tolerability of gemcitabine hydrochloride and carboplatin followed by paclitaxel in patients with stage IIIB-IV non-small cell lung cancer in regard to response rate, median survival, and one year survival.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is multicenter study.
- Part 1: Patients receive carboplatin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 2 courses. In week 7, all patients proceed to part 2 regardless of disease response.
- Part 2: Patients receive paclitaxel IV over 1-3 hours once weekly for 6 weeks. Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, Verenigde Staten, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
DISEASE CHARACTERISTICS:
Histologically confirmed non-small lung cancer (NSCLC) of any of the following histologic types:
- Squamous cell
- Adenocarcinoma
- Large cell carcinoma
- Unspecified
Evidence of at least 1 of the following criteria:
- Newly diagnosed inoperable stage IIIB (pleural effusion) disease
- Patients with stage III disease who are unable to undergo combined modality therapy
- Stage IV disease
- Recurrent non-small cell lung cancer regardless of site
- Diagnosis based on sputum cytology acceptable if confirmed by an independent pathologic review
Patients must have measurable or evaluable disease
- Measurable or evaluable disease must be outside the previous radiation field or a new lesion must be present
- Patients with brain metastases are eligible, provided they are either asymptomatic (no neurological symptoms or signs, no evidence of midline shift), or controlled (i.e., after surgical resection or radiotherapy/radiosurgery), and off all steroid therapy for at least two weeks with no evidence of progression by symptoms or radiologic imaging
PATIENT CHARACTERISTICS:
- ECOG performance status of 2 or 3 OR HIV-positive OR underwent prior status post organ transplantation
- No active serious infection (except for HIV infection)
- No symptomatic, untreated malignant pericardial effusion
- No congestive heart failure
- No other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm ^3
- Creatinine clearance ≥ 40 mL/min
- Creatinine ≤ 1.8 mg/dL
- Bilirubin < 1.5 mg/dL
- SGOT ≤ 2 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Males or females of reproductive potential may not participate unless they have agreed to use effective barrier contraceptive methods
- No prior malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior chemotherapy is not allowed
- At least three weeks since prior radiotherapy and recovered from all toxicities
- At least three weeks must have elapsed from major surgery and recovered from all adverse effects of surgery
- No prior colony-stimulating factors or interferon
No concurrent hormonal, biologic, or radiotherapy to measurable lesions
- Patients may receive concurrent palliative radiotherapy to small-field nonmeasurable sites of disease (e.g., painful bony metastases)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
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Tijd voor progressie
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Tijd tot falen van de behandeling
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Progressievrije overleving
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Algemeen overleven
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Secundaire uitkomstmaten
Uitkomstmaat |
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Duration of response (complete response and partial response)
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Julie Brahmer, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
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
- Carcinoom, niet-kleincellige long
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Antivirale middelen
- Enzymremmers
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Antineoplastische middelen, fytogeen
- Gemcitabine
- Carboplatine
- Paclitaxel
Andere studie-ID-nummers
- JHOC-J0428, CDR0000450843
- P30CA006973 (Subsidie/contract van de Amerikaanse NIH)
- JHOC-J0428
- BMS-JHOC-J0428
- JHOC-BRAAN-21048
- MSGCC-0060
- JHOC-04112308
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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