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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: |
NCT00079352 |
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Date of registration:
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08/03/2004 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors
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Scientific title:
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A Phase I Study of Flavopiridol in Combination With Gemcitabine and Irinotecan in Patients With Metastatic Cancer |
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Date of first enrolment:
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April 2004 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00079352 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety 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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Ian Rabinowitz |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of New Mexico |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologically confirmed solid tumor that is metastatic or unresectable
- Standard curative or palliative measures do not exist or are no longer effective
- No known brain metastases
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- More than 12 weeks
- WBC = 3,000/mm^3
- Absolute neutrophil count = 1,500/mm^3
- Platelet count = 100,000/mm^3
- Bilirubin normal
- AST and ALT = 2.5 times upper limit of normal
- Creatinine normal
- Creatinine clearance = 60 mL/min
- No venous thrombosis within the past 6 months
- No thrombotic cerebrovascular accident within the past 6 months
- No myocardial infarction within the past 6 months
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No ongoing or active infection
- No prior allergic reaction attributed to compounds of similar chemical or biological
composition to study agents
- No other concurrent uncontrolled medical condition that would preclude study
participation
- No psychiatric illness or social situation that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Prior biologic therapy allowed
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
and recovered
- Prior endocrine therapy allowed
- More than 4 weeks since prior radiotherapy and recovered
- Prior surgery allowed
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
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: gemcitabine hydrochloride
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Drug: alvocidib
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Drug: irinotecan hydrochloride
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Primary Outcome(s)
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Recommended phase II dose of flavopiridol defined as the highest dose for which no more than one patient develop a >= grade 3 toxicity
[Time Frame: 28 days]
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Secondary ID(s)
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CDR0000355358
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UNM-0903C
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NCI-2012-02580
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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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