CompletedPhase 2

Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer

Belgium, France, HungaryStarted 2003-06

Plain-language summary

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 metastatic penile cancer.

Who can participate

Age range

75 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 co…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Objective response rate measured by RECIST at 8 weeks after completion of study treatment

Trial details

NCT IDNCT00066391

SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2006-01

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