Clinical trial · Interventional

Docetaxel in Treating Patients With Solid Tumors

A Study of Population Pharmacokinetics of Docetaxel (Taxotere) in Caucasian and African-American Cancer Patients

NCT00003565CI-TRIAL-00023072completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (5)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Bladder Cancer	Malignant Bladder Neoplasm	CURATED_EXACT	0.92
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92
Head and Neck Cancer	Malignant Head and Neck Neoplasm	ALIAS	0.90
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92
Unspecified Adult Solid Tumor, Protocol Specific	Adult Solid Neoplasm	ALIAS	0.85

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
docetaxel	Drug	Docetaxel	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
docetaxel
description
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.
interventionNames
1. Drug: docetaxel

Primary outcomes (0)

[]

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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)

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* 0-2

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

References

Publications (1)

RESULTLewis 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. doi: 10.1158/1078-0432.CCR-06-2345. PMID 17545536

Registry

Dates and enrollment

Start: Sep 1, 1998
Primary completion: Jan 1, 2006
Completion: Jan 1, 2008
First posted: Jan 27, 2003
Last update posted: Jul 14, 2016
Enrollment: 109 (actual)
Lead sponsor: Alliance for Clinical Trials in Oncology OTHER
Collaborators: National Cancer Institute (NCI)
Keywords: stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, recurrent non-small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, stage III bladder cancer, recurrent bladder cancer, stage IV bladder cancer, stage IV nasopharyngeal cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, unspecified adult solid tumor, protocol specific, untreated metastatic squamous neck cancer with occult primary, recurrent metastatic squamous neck cancer with occult primary, pulmonary carcinoid tumor, stage III squamous cell carcinoma of the lip and oral cavity, stage III basal cell carcinoma of the lip, stage III verrucous carcinoma of the oral cavity, stage III mucoepidermoid carcinoma of the oral cavity, stage III adenoid cystic carcinoma of the oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV basal cell carcinoma of the lip, stage IV verrucous carcinoma of the oral cavity, stage IV mucoepidermoid carcinoma of the oral cavity, stage IV adenoid cystic carcinoma of the oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent basal cell carcinoma of the lip, recurrent verrucous carcinoma of the oral cavity, recurrent mucoepidermoid carcinoma of the oral cavity, recurrent adenoid cystic carcinoma of the oral cavity, stage III squamous cell carcinoma of the oropharynx, stage III lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent lymphoepithelioma of the oropharynx, stage III squamous cell carcinoma of the nasopharynx, stage III lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent lymphoepithelioma of the nasopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III inverted papilloma of the paranasal sinus and nasal cavity, stage III midline lethal granuloma of the paranasal sinus and nasal cavity, stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV inverted papilloma of the paranasal sinus and nasal cavity, stage IV midline lethal granuloma of the paranasal sinus and nasal cavity, stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent inverted papilloma of the paranasal sinus and nasal cavity, recurrent midline lethal granuloma of the paranasal sinus and nasal cavity, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity, recurrent salivary gland cancer, stage III salivary gland cancer, stage IV salivary gland cancer