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S0224, Docetaxel in Treating ...

S0224, Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer (TERMINATED)

Last Updated: 2018-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-11-30

Brief Summary

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

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have locally advanced or metastatic penile cancer.

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Detailed Description

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OBJECTIVES:

* Determine the confirmed complete and partial response rate in patients with locally advanced or metastatic epidermoid carcinoma of the penis treated with docetaxel.
* Determine the progression-free and overall survival of patients treated with this drug.
* Determine the qualitative and quantitative toxic effects of this drug in these patients.

OUTLINE: Patients receive docetaxel IV over 15-30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 3-5.8 years.

Conditions

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Penile Cancer

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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docetaxel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed epidermoid carcinoma of the penis

* Distant metastases (M1) OR
* Pathologically confirmed regional nodal metastases (N1-3)
* Measurable disease

* Soft tissue disease irradiated within the past 2 months is not considered measurable disease

PATIENT CHARACTERISTICS:

Age

* Not specified

Performance status

* Zubrod 0-2

Life expectancy

* Not specified

Hematopoietic

* White blood cell (WBC) count at least 3,000/mm\^3
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin no greater than upper limit of normal (ULN)
* Aspartate aminotransferase (SGOT) no greater than 2.5 times ULN

* If SGOT is greater than ULN, alkaline phosphatase must be no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 4 times ULN

* If alkaline phosphatase is greater than ULN, SGOT must be no greater than 1.5 times ULN

Renal

* Not specified

Other

* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer currently in complete remission
* No grade 2 or greater peripheral neuropathy
* No hypersensitivity to drugs formulated with polysorbate 80 (e.g., recombinant interferon alfa-2a, multivitamin infusion, etoposide, infliximab, or NovoSeven factor)

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy for penile cancer

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics
* At least 28 days since prior radiotherapy and recovered

Surgery

* Not specified

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tomasz M. Beer, MD

Role: STUDY_CHAIR

OHSU Knight Cancer Institute

Roland T. Skeel, MD

Role: STUDY_CHAIR

Medical University of Ohio Cancer Center

Locations

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St. Anthony Central Hospital

Denver, Colorado, United States

Site Status

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Denver, Colorado, United States

Site Status

Veterans Affairs Medical Center - Denver

Denver, Colorado, United States

Site Status

Montrose Memorial Hospital Cancer Center

Montrose, Colorado, United States

Site Status

St. Anthony North Hospital

Westminster, Colorado, United States

Site Status

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Salina Regional Health Center

Salina, Kansas, United States

Site Status