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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.
Last refreshed on: 28 January 2013
Main ID:  NCT00079352
Date of registration: 08/03/2004
Primary sponsor: National Cancer Institute (NCI)
Public title: Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors
Scientific title: A Phase I Study of Flavopiridol in Combination With Gemcitabine and Irinotecan in Patients With Metastatic Cancer
Date of first enrolment: April 2004
Target sample size: 24
Recruitment status: Completed
Study type:  Interventional
Study design:  Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
Key inclusion & exclusion criteria

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

- 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
Health Condition(s) or Problem(s) studied
Unspecified Adult Solid Tumor, Protocol Specific
Drug: alvocidib
Drug: gemcitabine hydrochloride
Drug: irinotecan hydrochloride
Primary Outcome(s)
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]
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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