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- Klinische proef NCT00081237
OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer
A Phase I Study of OSI-7904L In Combination With Oxaliplatin In Patients With Advanced Colo-Rectal Cancer
RATIONALE: OSI-7904L may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining OSI-7904L with oxaliplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of OSI-7904L and oxaliplatin in treating patients with refractory or recurrent advanced colorectal cancer.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity of OSI-7904L and oxaliplatin in patients with refractory or recurrent advanced colorectal cancer.
- Determine the maximum tolerated dose of this regimen in these patients.
- Determine a safe dose for this regimen in these patients.
Secondary
- Determine the pharmacokinetic profile of this regimen in these patients.
- Determine the safety profile of this regimen in these patients.
- Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is a nonrandomized, multicenter, open-label, dose-escalation study.
Patients receive oxaliplatin IV over 2 hours followed by OSI-7904L IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of OSI-7904L and oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. A maximum of 12 patients receive treatment at the MTD.
Patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for this study.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Hannover, Duitsland, D-30625
- Medizinische Hochschule Hannover
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England
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Manchester, England, Verenigd Koninkrijk, M20 4BX
- Christie Hospital N.H.S. Trust
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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 colorectal cancer
- Radiologic evidence of advanced disease
At least 1 measurable lesion at least 20 mm OR at least 10 mm by spiral CT scan
- Indicator lesions in a previously irradiated field are allowed provided the irradiated lesion has clearly progressed OR a new lesion has developed in the irradiated field
Failed 1, and only 1, line of prior chemotherapy for advanced/metastatic disease
- Disease progression during chemotherapy OR within 6 months after completion of treatment
No symptomatic brain metastases meeting any of the following criteria:
- Unstable
- Inadequately controlled with fixed-dose oral steroids
- Potentially life-threatening
- Required radiotherapy with the past 28 days
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
Hepatic
- AST and ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- Bilirubin < 1.5 times ULN
- No hepatitis
- No cirrhosis
Renal
- Creatinine < 1.5 times ULN
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- HIV negative
- No preexisting neuropathy ≥ grade 2
- No active or uncontrolled infection
- No other serious illness or medical condition
- No chronic alcohol abuse
- No known hypersensitivity to systemic liposomal formulations or compounds chemically related to OSI-7904L or oxaliplatin
- No prior psychiatric or neurologic condition that would preclude study compliance or giving informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 21 days since prior immunotherapy
- At least 21 days since prior monoclonal antibody therapy
Chemotherapy
- See Disease Characteristics
- At least 21 days since prior chemotherapy and recovered*
- No prior oxaliplatin NOTE: *Alopecia allowed
Endocrine therapy
- See Disease Characteristics
- At least 21 days since prior hormonal therapy
Radiotherapy
- See Disease Characteristics
- At least 21 days since prior radiotherapy and recovered
- No prior radiotherapy to more than 25% of bone marrow reserve
Surgery
- Recovered from prior surgery
Other
- At least 21 days since prior tyrosine kinase inhibitor therapy
- More than 21 days since prior investigational agents
- No other concurrent anticancer therapy
- No other concurrent investigational agents
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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Maximum tolerated dose and recommended dose for future trials as measured by CTC v3.0
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Secundaire uitkomstmaten
Uitkomstmaat |
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Safety profile as measured by CTC v3.0
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Response as measured by RECIST every 6 weeks (2 courses)
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Pharmacodynamics as measured by drug concentration in the blood during course 1
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Time to progression as measured by Kaplan Meier and RECIST every 6 weeks during treatment and then every 8 weeks
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Medewerkers en onderzoekers
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 het spijsverteringsstelsel
- Neoplasmata
- Neoplasmata per site
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Colon Ziekten
- Darmziekten
- Intestinale neoplasmata
- Rectale ziekten
- Colorectale neoplasmata
- Antineoplastische middelen
- Oxaliplatine
Andere studie-ID-nummers
- EORTC-16033
- OSI-EORTC-16033
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 .
Klinische onderzoeken op Colorectale kanker
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)VoltooidAdenocarcinoom van de dunne darm | Stadium III Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIA Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIB dunne darm adenocarcinoom AJCC v8 | Stadium IV Adenocarcinoom van de dunne darm AJCC v8 | Ampulla van Vater Adenocarcinoom | Stadium III... en andere voorwaardenVerenigde Staten
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University of UtahNational Cancer Institute (NCI)WervingVermoeidheid | Sedentaire levensstijl | Gemetastaseerd prostaatcarcinoom | Stadium IV prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVA prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVB prostaatkanker AJCC (American Joint Committee on Cancer) v8Verenigde Staten
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Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...VoltooidBestudeer Chinese vrouwen die zich niet hebben gehouden aan de richtlijnen voor screening op mammografie van de American Cancer SocietyVerenigde Staten
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BioNTech SESeventh Framework ProgrammeVoltooidBorstkanker (Triple Negative Breast Cancer (TNBC))Zweden, Duitsland
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Novartis PharmaceuticalsVoltooidGeavanceerde Triple Negative Breast Cancer (TNBC) met hoge TAM'sFrankrijk, Italië, Oostenrijk, Taiwan, Verenigde Staten, Spanje, Australië, Korea, republiek van, België, Duitsland, Hongkong, Kalkoen
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Rashmi Verma, MDNational Cancer Institute (NCI)WervingCastratieresistent prostaatcarcinoom | Gemetastaseerd prostaatadenocarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
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Jonsson Comprehensive Cancer CenterNog niet aan het wervenProstaatcarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Nog niet aan het wervenAnatomische fase II borstkanker AJCC v8 | Anatomische fase III borstkanker AJCC v8 | Borstcarcinoom in een vroeg stadium | Anatomische fase I Borstkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
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University of Southern CaliforniaNational Cancer Institute (NCI)WervingLokaal gevorderd pancreasadenocarcinoom | Inoperabel pancreasadenocarcinoom | Fase III Pancreaskanker American Joint Committee on Cancer v8Verenigde Staten
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Jonsson Comprehensive Cancer CenterIngetrokkenProstaat Adenocarcinoom | Prostaatkanker stadium II AJCC v8 | Stadium IIC prostaatkanker AJCC v8 | Stadium IIA prostaatkanker AJCC v8 | Stadium IIB prostaatkanker AJCC v8 | Fase I Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
Klinische onderzoeken op oxaliplatine
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SanofiVoltooid
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Taiho Pharmaceutical Co., Ltd.Yakult Honsha Co., LTDVoltooidColorectale kankerJapan
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Hebei Medical UniversityOnbekendMaagkanker | Lever metastaseChina
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Universidad de LeónWervingLokaal gevorderde darmkankerSpanje
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Wuhan Union Hospital, ChinaWervingVergevorderde maagkanker | Geavanceerde Gastro-oesofageale Junction AdenocarcinoomChina
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SanofiVoltooidMaagkankerKorea, republiek van
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QureBio Ltd.WervingGastro-oesofageale overgang (GEJ) AdenocarcinoomChina
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Xijing HospitalWervingLokaal gevorderd adenocarcinoom van de maagChina
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Kangbuk Samsung HospitalBeëindigdMaagkankerKorea, republiek van
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The First Affiliated Hospital of Zhengzhou UniversityNog niet aan het werven