A Phase I Study of Flavopiridol in Combination With Gemcitabine and Irinotecan in Patients With Metastatic Cancer
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Study of Flavopiridol in Combination With Gemcitabine and Irinotecan in Patients With Metastatic Cancer
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
solid tumors.
II. Determine the toxicity profile of this regimen in these patients.
OUTLINE: This is a dose-escalation study of flavopiridol.
Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 30 minutes on
days 1 and 15. Patients also receive flavopiridol IV over 60 minutes on days 2 and 16.
Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Recommended phase II dose of flavopiridol defined as the highest dose for which no more than one patient develop a >= grade 3 toxicity
Outcome Time Frame:
28 days
Safety Issue:
Yes
Principal Investigator
Ian Rabinowitz
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of New Mexico
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-02580
NCT ID:
NCT00079352
Start Date:
April 2004
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
Name | Location |
|---|---|
| University of New Mexico | Albuquerque, New Mexico 87131 |
