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Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors
This study has been completed.
Study NCT00016185   Information provided by National Cancer Institute (NCI)
First Received: May 6, 2001   Last Updated: July 23, 2008   History of Changes

May 6, 2001
July 23, 2008
March 2001
 
 
 
Complete list of historical versions of study NCT00016185 on ClinicalTrials.gov Archive Site
 
 
 
Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors
Phase I Study Of Flavopiridol And Docetaxel (Taxotere) In Patients With Advanced Cancers

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 and docetaxel in treating patients who have advanced solid tumors.

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.

Phase I
Interventional
Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: alvocidib
  • Drug: docetaxel
 
El-Rayes BF, Gadgeel S, Parchment R, Lorusso P, Philip PA. A phase I study of flavopiridol and docetaxel. Invest New Drugs. 2006 Jul;24(4):305-10.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00016185
 
CDR0000068605, WSU-C-2197, NCI-1610
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Study Chair: Philip A. Philip, MD, PhD, FRCP Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
June 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP