Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer
NCT ID: NCT00066391
Last Updated: 2012-09-24
Study Results
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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COMPLETED
PHASE2
INTERVENTIONAL
2003-06-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combining irinotecan with cisplatin in treating patients who have locally advanced or metastatic penile cancer.
Detailed Description
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* Determine the anticancer activity of irinotecan and cisplatin in patients with locally advanced or metastatic penile cancer.
* Determine the objective response rate and duration of response in patients treated with this regimen.
* Determine the acute side effects of this regimen in these patients.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive irinotecan IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 1-3 hours on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients not undergoing local treatment receive up to 8 courses. Patients planning to undergo surgery receive up to 4 courses.
Patients are followed every 8 weeks until disease progression and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 13-28 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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cisplatin
irinotecan hydrochloride
neoadjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed penile squamous cell carcinoma
* Locally advanced or metastatic disease
* T3, N1-2 OR T4, N3, M1
* Measurable disease outside of any previously irradiated field
* No clinical signs of brain metastases
PATIENT CHARACTERISTICS:
Age
* 75 and under
Performance status
* WHO 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN in the presence of liver metastases)
* Transaminases no greater than 2.5 times ULN (5 times ULN in the presence of liver metastases)
Renal
* Glomerular filtration rate at least 60 mL/min
Gastrointestinal
* No chronic diarrhea
* No unresolved bowel obstruction
* No chronic inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
Other
* No other prior or concurrent malignancy except adequately treated skin cancer
* No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* More than 4 weeks since prior radiotherapy
* No concurrent radiotherapy for pain control
Surgery
* Not specified
Other
* No other concurrent experimental or anticancer therapy
75 Years
MALE
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Christine Theodore, MD
Role: STUDY_CHAIR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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U.Z. Gasthuisberg
Leuven, , Belgium
Institut Gustave Roussy
Villejuif, , France
National Institute of Oncology
Budapest, , Hungary
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, , Netherlands
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, , Poland
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
Countries
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References
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Theodore C, Skoneczna I, Bodrogi I, Leahy M, Kerst JM, Collette L, Ven K, Marreaud S, Oliver RDT; EORTC Genito-Urinary Tract Cancer Group. A phase II multicentre study of irinotecan (CPT 11) in combination with cisplatin (CDDP) in metastatic or locally advanced penile carcinoma (EORTC PROTOCOL 30992). Ann Oncol. 2008 Jul;19(7):1304-1307. doi: 10.1093/annonc/mdn149. Epub 2008 Apr 15.
Other Identifiers
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EORTC-30992
Identifier Type: -
Identifier Source: secondary_id
EORTC-30992
Identifier Type: -
Identifier Source: org_study_id