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Penile CancerPhase 2NCT00058448

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

A Phase 2 study testing docetaxel in people with Penile Cancer, run by SWOG Cancer Research Network at 49 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Penile Cancer
What is being tested?
docetaxel
How many people
1 participants
Where
49 sitesUnited States
Study dates
Oct 2004to Nov 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

49 sites in 1 country.

49 sites in 1 country

United States49 sites

  • Rose Ramer Cancer Clinic at Anderson Area Medical Center

    Anderson, South Carolina, 29621

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Deaconess Billings Clinic - Downtown

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare

    Billings, Montana, 59101

  • Deaconess Billings Clinic Cancer Center

    Billings, Montana, 59107

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • St. James Community Hospital

    Butte, Montana, 59701

  • Adena Regional Medical Center

    Chillicothe, Ohio, 54601

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Riverside Cancer Services

    Columbus, Ohio, 43215

  • Mount Carmel West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • St. Anthony Central Hospital

    Denver, Colorado, 80204

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

    Denver, Colorado, 80217-3364

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Community Oncology Group - Independence

    Independence, Ohio, 44131

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Eastern Montana Cancer Center

    Miles City, Montana, 59301

  • Community Medical Center

    Missoula, Montana, 59801

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59802

  • Montrose Memorial Hospital Cancer Center

    Montrose, Colorado, 81401

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104

  • Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97239

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57104

  • Avera McKennan Hospital and University Health Center

    Sioux Falls, South Dakota, 57105

  • Medical X-Ray Center

    Sioux Falls, South Dakota, 57105

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29304

  • Mercy Medical Center Oncology Unit

    Springfield, Ohio, 45504

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital

    Westerville, Ohio, 43081

  • St. Anthony North Hospital

    Westminster, Colorado, 80030

  • Exempla Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • Wilson Medical Center

    Wilson, North Carolina, 27893

  • Cleveland Clinic - Wooster

    Wooster, Ohio, 44691

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: Phase II Study Of Weekly Docetaxel In Patients With Advanced Epidermoid Carcinoma Of The Penis

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.

Read the detailed description

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
Penile Cancer
Being tested
docetaxel
Keywords
stage II penile cancer, stage III penile cancer, stage IV penile cancer
Medical subject headings
Penile Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks during treatment

    Measured: up to 24 weeks during treatment

Secondary outcomes (1)

  1. Safety as measured by Common Terminology Criteria for Adverse Events (CTC) Version 3.0 every 4 weeks

    Measured: up to 24 weeks during treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2003 (estimated)
  2. Study startOct 2004
  3. Primary completionNov 2005
  4. Study completionNov 2005

Why it stopped: Study terminated due to poor patient recruitment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00058448
Sponsor's protocol ID
CDR0000297621
Other IDs
S0224, U10CA032102
Status last verified
Apr 2013
First submitted
7 Apr 2003
Last updated
28 Jun 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing docetaxel in people with Penile Cancer, run by SWOG Cancer Research Network at 49 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study terminated due to poor patient recruitment.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks during treatment (time frame: up to 24 weeks during treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00058448.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018.

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