Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol with docetaxel in treating patients who have advanced solid tumors.

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
-----------------
* Drug: alvocidib
* Drug: docetaxel


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: alvocidib|nan|
|Drug: docetaxel|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unspecified adult solid tumor, protocol specific