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

NCT00058448 | Terminated Phase 2

• 3 other identifiers: CDR0000297621S0224U10CA032102
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 49

Brief 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.

Conditions

Penile Cancer

Keywords

stage II penile cancer; stage III penile cancer; stage IV penile cancer

Outcome Measures

Primary Outcomes (1)

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

  up to 24 weeks during treatment

Secondary Outcomes (1)

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

  up to 24 weeks during treatment

Interventions

docetaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator
• Eastern Cooperative Oncology Group: collaborator

Study Sites (49)

St. Anthony Central Hospital

Denver, Colorado, 80204, United States

Location

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

Denver, Colorado, 80217-3364, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, United States

Location

Montrose Memorial Hospital Cancer Center

Montrose, Colorado, 81401, United States

Location

St. Anthony North Hospital

Westminster, Colorado, 80030, United States

Location

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, 80033, United States

Location

Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Deaconess Billings Clinic - Downtown

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare

Billings, Montana, 59101, United States

Location

Deaconess Billings Clinic Cancer Center

Billings, Montana, 59107, United States

Location

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

St. James Community Hospital

Butte, Montana, 59701, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Eastern Montana Cancer Center

Miles City, Montana, 59301, United States

Location

Community Medical Center

Missoula, Montana, 59801, United States

Location

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

Missoula, Montana, 59802, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Wilson Medical Center

Wilson, North Carolina, 27893, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 54601, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214, United States

Location

CCOP - Columbus

Columbus, Ohio, 43215, United States

Location

Grant Riverside Cancer Services

Columbus, Ohio, 43215, United States

Location

Mount Carmel West Hospital

Columbus, Ohio, 43222, United States

Location

Doctors Hospital at Ohio Health

Columbus, Ohio, 43228, United States

Location

Grady Memorial Hospital

Delaware, Ohio, 43015, United States

Location

Community Oncology Group - Independence

Independence, Ohio, 44131, United States

Location

Fairfield Medical Center

Lancaster, Ohio, 43130, United States

Location

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, 45750, United States

Location

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Newark, Ohio, 43055, United States

Location

Mercy Medical Center Oncology Unit

Springfield, Ohio, 45504, United States

Location

Community Hospital of Springfield and Clark County

Springfield, Ohio, 45505, United States

Location

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

Westerville, Ohio, 43081, United States

Location

Cleveland Clinic - Wooster

Wooster, Ohio, 44691, United States

Location

Genesis - Good Samaritan Hospital

Zanesville, Ohio, 43701, United States

Location

Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Rose Ramer Cancer Clinic at Anderson Area Medical Center

Anderson, South Carolina, 29621, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29304, United States

Location

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, 57104, United States

Location

Avera McKennan Hospital and University Health Center

Sioux Falls, South Dakota, 57105, United States

Location

Medical X-Ray Center

Sioux Falls, South Dakota, 57105, United States

Location

Welch Cancer Center

Sheridan, Wyoming, 82801, United States

Location

MeSH Terms

Conditions

Penile Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Penile Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Tomasz M. Beer, MD

  OHSU Knight Cancer Institute

  STUDY CHAIR

• Roland T. Skeel, MD

  Medical University of Ohio Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2003
• First Posted: April 9, 2003
• Study Start: October 1, 2004
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: June 28, 2018

Record last verified: 2013-04

Locations

US (49)