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- Klinische proef NCT00021333
Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer
Phase II Evaluation Of Paclitaxel And Cisplatin In Combination With Split Course Hyperfractionated Radiation Therapy And Granulocyte-Colony Stimulating Factor In Previously Irradiated Patients With Locally Recurrent Carcinoma Of The Head And Neck, And Lung
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may make tumor cells more sensitive to radiation therapy.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel and cisplatin plus radiation therapy followed by filgrastim in treating patients who have recurrent head and neck cancer or lung cancer.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
OBJECTIVES: I. Determine the response rate of patients with locally recurrent carcinoma of the head and neck or lung treated with paclitaxel and cisplatin with concurrent radiotherapy followed by filgrastim (G-CSF). II. Assess the toxicity of this regimen in these patients. III. Determine the time to progression and the sites and pattern of progression in patients treated with this regimen. IV. Determine the median, 1-year, and 2-year survival rates of patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to disease (squamous cell carcinoma of the head and neck vs salivary gland malignancy or other non-squamous cell carcinoma of the head and neck vs lung cancer). Patients receive paclitaxel IV over 1 hour and cisplatin IV over 30-120 minutes on days 1-5. Patients undergo radiotherapy twice daily on days 1-5. Patients receive filgrastim (G-CSF) subcutaneously on days 6-13 or until blood counts recover. Treatment repeats every 2 weeks for a total of 4 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 42-84 patients (14-28 per stratum) will be accrued for this study within 2-4 years.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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New Jersey
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Flemington, New Jersey, Verenigde Staten, 08822
- Hunterdon Regional Cancer Center
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Lakewood, New Jersey, Verenigde Staten, 08701
- Kimball Medical Center
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Millville, New Jersey, Verenigde Staten, 08332
- South Jersey Regional Cancer Center
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Mount Holly, New Jersey, Verenigde Staten, 08060
- Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
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Red Bank, New Jersey, Verenigde Staten, 07701
- Riverview Medical Center - Booker Cancer Center
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Toms River, New Jersey, Verenigde Staten, 08755
- Community Medical Center
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Trenton, New Jersey, Verenigde Staten, 08629
- St. Francis Medical Center
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Pennsylvania
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Altoona, Pennsylvania, Verenigde Staten, 16602
- Bon Secours-Holy Family Health System
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Drexel Hill, Pennsylvania, Verenigde Staten, 19026
- Delaware County Memorial Hospital
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Harrisburg, Pennsylvania, Verenigde Staten, 17105-8700
- Pinnacle Health Hospitals
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Johnstown, Pennsylvania, Verenigde Staten, 15905
- Conemaugh Memorial Hospital
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Langhorne, Pennsylvania, Verenigde Staten, 19047
- Saint Mary Regional Center
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Lansdale, Pennsylvania, Verenigde Staten, 19446-1200
- Central Montgomery Medical Center
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Paoli, Pennsylvania, Verenigde Staten, 19301-1792
- Paoli Memorial Hospital
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Philadelphia, Pennsylvania, Verenigde Staten, 19111
- Fox Chase Cancer Center
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Pottstown, Pennsylvania, Verenigde Staten, 19464
- Pottstown Memorial Regional Cancer Center
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Reading, Pennsylvania, Verenigde Staten, 19612-6052
- Reading Hospital and Medical Center
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West Grove, Pennsylvania, Verenigde Staten, 19390
- Southern Chester County 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: Diagnosis of 1 of the following: Previously irradiated, locally recurrent squamous cell carcinoma of the head and neck (SCCHN) or head and neck skin/appendages with no distant metastases New second or subsequent primary SCCHN in a previously irradiated field with no distant metastases Salivary gland malignancy or other non-squamous cell primary head and neck cancer Previously irradiated, locally recurrent carcinoma of the lung No clinical evidence of symptomatic bone or brain metastases requiring radiotherapy No leptomeningeal metastases requiring intrathecal therapy
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No active, uncontrolled congestive heart failure or arrhythmia within the past 6 months Other: No pre-existing neuropathy grade 2 or greater interfering with daily activities No prior allergy to drugs using Cremophor EL No hypersensitivity to E. coli-derived proteins No significant concurrent medical or psychiatric disorder that would preclude study No other condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 3 months after study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 months since prior radiotherapy Prior or concurrent cumulative radiotherapy dose to spinal cord no greater than 5,000 cGy Surgery: Not specified Other: Concurrent beta-blockers, digitalis derivatives, or calcium-channel blocking agents allowed if cardiac conditions are stable
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Corey J. Langer, MD, Fox Chase Cancer Center
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie 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
- recidiverende niet-kleincellige longkanker
- terugkerende kleincellige longkanker
- recidiverend plaveiselcelcarcinoom van de lip en mondholte
- terugkerend basaalcelcarcinoom van de lip
- recidiverend verrukeus carcinoom van de mondholte
- recidiverend mucoepidermoïd carcinoom van de mondholte
- recidiverend adenoïd cystisch carcinoom van de mondholte
- recidiverend plaveiselcelcarcinoom van de orofarynx
- recidiverend lymfoepithelioom van de orofarynx
- recidiverend plaveiselcelcarcinoom van de nasopharynx
- recidiverend lymfoepithelioom van de nasopharynx
- recidiverend plaveiselcelcarcinoom van de hypofarynx
- recidiverend plaveiselcelcarcinoom van het strottenhoofd
- recidiverend verrukeus carcinoom van het strottenhoofd
- recidiverend plaveiselcelcarcinoom van de neusbijholten en de neusholte
- recidiverend middellijn dodelijk granuloom van de neusbijholten en de neusholte
- recidiverend esthesioneuroblastoom van de neusbijholten en de neusholte
- terugkerende speekselklierkanker
- recidiverend omgekeerd papilloom van de neusbijholten en de neusholte
- terugkerende schildklierkanker
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Neoplasmata
- Longziekten
- Neoplasmata per site
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Hoofd- en nekneoplasmata
- Longneoplasmata
- Moleculaire mechanismen van farmacologische werking
- Antineoplastische middelen
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Antineoplastische middelen, fytogeen
- Paclitaxel
- Cisplatine
Andere studie-ID-nummers
- CDR0000068770
- P30CA006927 (Subsidie/contract van de Amerikaanse NIH)
- FCCC-99025
- NCI-G01-1983
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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