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CompletedPhase 2NCT00003565
Official study title

Docetaxel in Treating Patients With Solid Tumors

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studieddocetaxel

The study team can explain what participation involves.

Who it may be forBladder Cancer · Breast Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 14, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?74 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Drug: docetaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Northeast Alabama Regional Medical CenterAnniston, Alabama
  • Rebecca and John Moores UCSD Cancer CenterLa Jolla, California
  • Veterans Affairs Medical Center - San DiegoSan Diego, California
  • UCSF Comprehensive Cancer CenterSan Francisco, California
  • Veterans Affairs Medical Center - San FranciscoSan Francisco, California
  • CCOP - Christiana Care Health ServicesNewark, Delaware
  • Lombardi Cancer CenterWashington D.C., District of Columbia
  • Walter Reed Army Medical CenterWashington D.C., District of Columbia
  • Veterans Affairs Medical Center - Washington, DCWashington D.C., District of Columbia
  • Broward General Medical CenterFort Lauderdale, Florida
  • Memorial Regional Hospital Comprehensive Cancer CenterHollywood, Florida
  • CCOP - Mount Sinai Medical CenterMiami Beach, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 14, 2016. Always confirm current availability with the study team.

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