Clinical trial · Interventional
Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer
Phase II Study of Irinotecan (CPT 11) and Cisplatin (CDDP) in Metastatic or Locally Advanced Penile Carcinoma
NCT00066391CI-TRIAL-00008125completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Penile Cancer | Malignant Penile Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective response rate measured by RECIST at 8 weeks after completion of study treatment
Secondary outcomes (2)
- measure
- Duration of response as measured by Kaplan-Meier every 8 weeks until progression, and then every 3 months thereafter
- measure
- Toxicity as measured by NCI-CTC v2.0 every 8 weeks until progression
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 75 Years
Show eligibility criteria text
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 therapyReferences
Publications (1)
- RESULTTheodore 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. PMID 18417462