Docetaxel in Treating Patients With Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00003565
First received: November 1, 1999
Last updated: September 28, 2013
Last verified: September 2013

November 1, 1999
September 28, 2013
September 1998
January 2006   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00003565 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Docetaxel in Treating Patients With Solid Tumors
A Study of Population Pharmacokinetics of Docetaxel (Taxotere) in Caucasian and African-American Cancer Patients

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to compare the effectiveness of docetaxel in treating Caucasian and African American patients who have solid tumors.

OBJECTIVES:

  • Compare the population pharmacokinetics of docetaxel in Caucasians and African American patients with solid tumors.
  • Compare the pharmacodynamic effect of a single dose of docetaxel in relation to hematological toxicity in these patient populations.
  • Determine the CYP3A4 genotype and P-glycoprotein (P-gp) expression and their relationship to docetaxel clearance in these patient populations.

OUTLINE: Patients receive docetaxel IV over 1 hour on day 1. Patients may receive additional courses beginning 21 days after the first docetaxel dose at the discretion of the physician.

PROJECTED ACCRUAL: Approximately 80 patients (40 Caucasian and 40 African American) will be accrued for this study.

Interventional
Phase 2
Primary Purpose: Treatment
  • Bladder Cancer
  • Breast Cancer
  • Head and Neck Cancer
  • Lung Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
Drug: docetaxel
Not Provided
Lewis LD, Miller AA, Rosner GL, Dowell JE, Valdivieso M, Relling MV, Egorin MJ, Bies RR, Hollis DR, Levine EG, Otterson GA, Millard F, Ratain MJ; Cancer and Leukemia Group B. A comparison of the pharmacokinetics and pharmacodynamics of docetaxel between African-American and Caucasian cancer patients: CALGB 9871. Clin Cancer Res. 2007 Jun 1;13(11):3302-11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
109
January 2008
January 2006   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically proven unresectable solid tumors (e.g., lung, breast, head and neck, bladder)
  • Clinically suitable for treatment with single agent docetaxel
  • Caucasian (at least 2 generations originating in any of the original peoples of Europe, North Africa, or the Middle East) OR
  • African American (at least 2 generations originating in any of the black racial groups of Africa)
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Not specified

Menopausal status:

  • Not specified

Performance status:

  • 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,500/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • AST no greater than 1.5 times ULN AND
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal:

  • BUN no greater than 1.5 times ULN
  • Creatinine no greater 1.5 times ULN

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior bone marrow transplantation

Chemotherapy:

  • No prior docetaxel
  • Prior paclitaxel allowed
  • 1 or 2 prior chemotherapy regimens allowed
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormones for disease related conditions
  • Concurrent steroids for adrenal failure allowed

Radiotherapy:

  • At least 2 weeks since prior radiotherapy
  • Palliative radiotherapy allowed except whole brain irradiation for CNS disease

Surgery:

  • Not specified

Other:

  • At least 48 hours since prior or concurrent ethanol (CYP3A enzyme inducer) or grapefruit juice (CYP3A enzyme inhibitor)
  • At least 7 days since prior or concurrent CYP450 inducing drugs:

    • Antiseizure medications: phenobarbital, phenytoin, carbamazepine, or lamotrigine
    • Anti-TB therapy: rifampin, isoniazid, or sulfinpyrazone
  • At least 7 days since prior or concurrent CYP450 3A inhibiting drugs:

    • Macrolides: erythromycin, clarithromycin, azithromycin, or roxithromycin
    • Azoles: ketoconazole, fluconazole, or itraconazole
    • Other antibiotics: metronidazole or chloramphenicol
    • Anti-HIV drugs: ritonavir, indinavir, nelfinavir, or delavirdine
    • Immunosuppressive agents: cyclosporine
    • Antidepressant agent: nefazodone
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Puerto Rico
 
NCT00003565
CDR0000066631, U10CA031946, CLB-9871
No
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Lionel D. Lewis, MD Norris Cotton Cancer Center
Alliance for Clinical Trials in Oncology
September 2013

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