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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 January 2013 |
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Main ID: |
NCT00074321 |
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Date of registration:
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10/12/2003 |
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Primary sponsor: |
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Public title:
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Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors
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Scientific title:
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A Phase I And Pharmacogenetic Study Of CPT-11, Oxaliplatin, And Capecitabine In Patients With Solid Tumors |
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Date of first enrolment:
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November 2003 |
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Target sample size:
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84 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00074321 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Matthew Goetz |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologically confirmed solid tumor for which there is no known standard therapy
that is potentially curative or capable of extending life expectancy
- Unresectable disease
- Willing to provide biologic specimens to determine UGT1A1 genotype
- No CNS metastases
- Prior CNS metastases allowed provided patient was treated with surgery and/or
radiotherapy and is stable for more than 8 weeks
- Performance status - ECOG 0-2
- At least 12 weeks
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9.0 g/dL
- Bilirubin no greater than upper limit of normal (ULN) for patients with 6/6 UGT1A1
genotype (1.5 times ULN for patients with 6/7 [closed to accrual as of 8/24/06] or
7/7 UGT1A1 genotype)
- AST no greater than 3 times ULN (5 times ULN if there is liver involvement)
- Creatinine no greater than 1.5 times ULN
- No New York Heart Association class III or IV heart disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior allergy to platinum compounds, irinotecan, or to antiemetics or
antidiarrheals appropriate for administration with study therapy
- No uncontrolled infection
- No seizure disorder
- No peripheral neuropathy grade 2 or greater
- More than 4 weeks since prior biologic therapy
- More than 4 weeks since prior immunotherapy
- No concurrent immunotherapy
- No concurrent prophylactic colony-stimulating factor therapy
- More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
and recovered
- No other concurrent chemotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy
- No prior radiotherapy to more than 25% of the bone marrow
- No concurrent radiotherapy
- See Disease Characteristics
- No other concurrent investigational therapy
- No concurrent sorivudine, brivudine, lamivudine, or stavudine
- No concurrent enrollment in any other study involving a pharmacologic agent for
symptom control or therapeutic intent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Unspecified Adult Solid Tumor, Protocol Specific
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Intervention(s)
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Drug: capecitabine
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Drug: irinotecan hydrochloride
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Drug: oxaliplatin
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Other: laboratory biomarker analysis
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Other: pharmacological study
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Primary Outcome(s)
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MTD defined as one dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) assessed using NCI CTCAE v3.0
[Time Frame: 3 weeks]
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Secondary Outcome(s)
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Adverse events profile assessed using NCI CTCAE v3.0
[Time Frame: Up to 3 months]
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Incidence of UTG1A1*28 polymorphism
[Time Frame: Up to 3 months]
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Response profile using RECIST criteria
[Time Frame: Up to 3 months]
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Time to progression
[Time Frame: Up to 3 months]
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Time to treatment failure
[Time Frame: From registration to documentation of progression, unacceptable toxicity, or refusal to continue participation by the patient, assessed up to 3 months]
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Time until any treatment related toxicity
[Time Frame: Up to 3 months]
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Time until hematologic nadirs (WBC, ANC, platelets)
[Time Frame: Up to 3 months]
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Time until treatment related grade 3+ toxicity
[Time Frame: Up to 3 months]
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Toxicity profile assessed using NCI CTCAE v3.0
[Time Frame: Up to 3 months]
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Secondary ID(s)
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CDR0000344367
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MC0311
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NCI-2012-01444
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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