Status:
COMPLETED
Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of flavopiridol when given together with gemcitabine and irinotecan in treating patients with unresectable or metastatic solid tumors. Dru...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of flavopiridol in combination with gemcitabine and irinotecan in patients with unresectable or metastatic so...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00079352
Start Date
April 1 2004
Last Update
January 25 2013
Active Locations (1)
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1
University of New Mexico
Albuquerque, New Mexico, United States, 87106