Single Center Open-Label Non-Comparative Phase I Dose Finding Study Of Weekly Flavopiridol In Combination With Weekly Docetaxel In Patients With Advanced Solid Tumors
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Single Center Open-Label Non-Comparative Phase I Dose Finding Study Of Weekly Flavopiridol In Combination With Weekly Docetaxel In Patients With Advanced Solid Tumors
OBJECTIVES:
- Determine the maximum tolerated dose of flavopiridol when administered in combination
with 2 different doses of docetaxel in patients with advanced solid tumors.
- Determine the clinical pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the therapeutic activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of flavopiridol.
Patients receive docetaxel IV over 30 minutes followed at least 4 hours later by
flavopiridol IV over 1 hour on days 1, 8, and 15. Courses repeat every 4 weeks 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 at least 2
of 6 patients experience dose-limiting toxicity. Separate MTDs of flavopiridol are
determined when flavopiridol is combined with 2 different doses of docetaxel. A total of 10
patients are treated at each flavopiridol MTD.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 6-56 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed advanced solid tumor that is refractory to standard therapy
or for which no standard therapy exists
- Measurable or evaluable disease
- No symptomatic or untreated CNS metastases or primary CNS neoplasm
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,500/mm3
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 8 g/dL
Hepatic
- Bilirubin no greater than upper limit of normal (ULN)
- SGOT/SGPT no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN
OR
- Alkaline phosphatase no greater than 2.5 times ULN if SGOT/SGPT no greater than ULN
Renal
- Creatinine no greater than 1.5 mg/dL
Cardiovascular
- No history of cardiac arrhythmias
- No congestive heart failure
- No myocardial infarction within the past 6 months
Other
- No concurrent serious or uncontrolled infection
- No diabetes not adequately controlled with medication
- No peripheral neuropathy greater than grade 1
- No known allergy to docetaxel or other medications formulated in Polysorbate 80
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 4 weeks since prior immunotherapy
Chemotherapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- Prior taxanes allowed
- No prior flavopiridol
Endocrine therapy
- At least 4 weeks since prior hormonal therapy
Radiotherapy
- At least 4 weeks since prior radiotherapy
Surgery
- Not specified
Other
- Recovered from prior therapy
- No prior enrollment in this study
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Gary K. Schwartz, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
AVENTIS-HMR1275A/1501
NCT ID:
NCT00045448
Start Date:
April 2002
Completion Date:
December 2009
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
