Phase I Study Of Flavopiridol And Docetaxel (Taxotere) In Patients With Advanced Cancers
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase I Study Of Flavopiridol And Docetaxel (Taxotere) In Patients With Advanced Cancers
OBJECTIVES:
- Determine the dose-limiting toxic effects and maximum tolerated dose of flavopiridol
and docetaxel in patients with advanced solid tumors.
- Determine the objective response rate and duration of response in patients treated with
this regimen.
- Determine the pharmacokinetics of these drugs in this patient population.
OUTLINE: This is a dose-escalation study.
Patients receive docetaxel IV over 60 minutes on day 1 and flavopiridol IV continuously over
24 hours on day 2. Treatment repeats every 3 weeks in the absence of disease progression or
unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of docetaxel and flavopiridol until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 9-11
months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed metastatic or unresectable solid tumor
- No standard relatively effective curative or palliative measures exist
- Measurable disease in at least 1 dimension
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- No known clinically active and uncontrolled brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
- Karnofsky 60-100%
Life expectancy:
- More than 12 weeks
Hematopoietic:
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin normal
- ALT/AST no greater than 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
Renal:
- Creatinine normal
Cardiovascular:
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other:
- No prior allergic reactions to compounds of similar chemical or biologic composition
to flavopiridol or docetaxel
- No other uncontrolled concurrent illness that would preclude study participation
- No ongoing or active infection
- No psychiatric illness or social situations that would preclude study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunotherapy
Chemotherapy:
- At least 6 months since prior taxane therapy
- At least 4 weeks since other prior chemotherapy (6 weeks for nitrosoureas or
mitomycin) and recovered
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy except contraceptives, appetite stimulants, or
replacement steroids
Radiotherapy:
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Other:
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Philip A. Philip, MD, PhD, FRCP
Investigator Role:
Study Chair
Investigator Affiliation:
Barbara Ann Karmanos Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000068605
NCT ID:
NCT00016185
Start Date:
March 2001
Completion Date:
December 2005
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
