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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00021073 |
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Date of registration:
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11/07/2001 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Combination Chemotherapy in Treating Patients With Advanced Cancer
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Scientific title:
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Phase I Study of Flavopiridol in Combination With 5-Fluorouracil, Leucovorin and Irinotecan in Patients With Advanced Malignancies |
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Date of first enrolment:
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May 2001 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00021073 |
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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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Phase:
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Phase 1
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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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Keith Bible |
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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 malignancy
- Unresectable tumor
- No known standard therapy with curative potential or capability of extending
life expectancy
- No untreated CNS metastases
- 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 8 g/dL
- Direct bilirubin no greater than upper limit of normal (ULN)
- AST no greater than 3 times ULN (5 times ULN if liver metastases present)
- Creatinine no greater than 1.5 times ULN
- No New York Heart Association class III or IV heart disease
- No seizure disorder
- No uncontrolled infection
- No baseline diarrhea, defined as at least 4 loose or liquid stools/day
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- More than 4 weeks since prior biologic therapy
- More than 4 weeks since prior immunotherapy
- No concurrent immunotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
and fully recovered from acute reversible effects
- No other concurrent chemotherapy
- More than 4 weeks since prior radiotherapy
- No prior radiotherapy to more than 25% of bone marrow
- No concurrent radiotherapy
- No other concurrent ancillary investigational therapy
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: fluorouracil
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Drug: leucovorin calcium
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Drug: alvocidib
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Drug: irinotecan hydrochloride
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Primary Outcome(s)
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Number and severity of toxicity incidents of alvocidib, 5-fluorouracil, leucovorin calcium with and without irinotecan hydrochloride, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
[Time Frame: Up to 5 years]
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Secondary Outcome(s)
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Number of responses (complete response, partial response, stable disease, and progressive disease) assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)
[Time Frame: Up to 5 years]
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Secondary ID(s)
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MC0014
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MAYO-MC0014
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NCI-2012-02389
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NCI-2450
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2450
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CDR0000068745
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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