- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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England
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Manchester, England, Det Forenede Kongerige, M20 4BX
- Christie Hospital N.H.S. Trust
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Hannover, Tyskland, D-30625
- Medizinische Hochschule Hannover
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Maximum tolerated dose and recommended dose for future trials as measured by CTC v3.0
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Sekundære resultatmål
Resultatmål |
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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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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (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
Andre undersøgelses-id-numre
- EORTC-16033
- OSI-EORTC-16033
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