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Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer Clinical research trials and Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer. Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer  Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer
Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer
For Condition: stage 4 penile cancer,stage 3 penile cancer,penile squamous cell carcinoma
Status: Recruiting
Sponsor(s): EORTC Genito-Urinary Tract Cancer Cooperative Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining irinotecan with cisplatin may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining irinotecan with cisplatin in treating patients who have locally advanced or metastaticpenile cancer.
Details: OBJECTIVES: - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChristineTheodore, , Institut Gustave Roussy
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-16-332-211
Additional Information:
Study ID Numbers: CDR0000315655; EORTC-30992
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066391
Other Stage 3 Penile Cancer Studies:
1. Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer
2. Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer
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Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer
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