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A phase II multicentre study of irinotecan (CPT 11) in combination with cisplatin (CDDP) in metastatic or locally advanced penile carcinoma (EORTC PROTOCOL 30992).

AbstractBACKGROUND:
The aim of this study is to determine efficacy and feasibility of the combination regimen irinotecan and cisplatin in patients with cisplatin advanced penile cancer.
PATIENTS AND METHODS:
Patients with T3, T4, N1, N2, N3 or M1 cisplatin advanced penile cancer were treated with a combination of irinotecan (60 mg/m(2)) on days 1, 8 and 15 and cisplatin (80 mg/m(2)) administered every 28 days. Patients were treated either in the neo-adjuvant setting for T3 or N1-N2 disease with a maximum of four cycles before surgery or up to eight cycles for T4 or N3 or M1 disease. The study was designed with the aim to exclude a response rate (complete response + partial response) <30% (alpha = 10%, power = 95%).
RESULTS:
Twenty-eight patients were included and evaluated for toxicity, and 26 eligible patients were evaluated for response. Toxicity was acceptable with three cases of grade 3 diarrhoea and two cases of grade 4 neutropenic fever. There were eight responses (two complete response and six partial response) (30.8%, 80% confidence interval 18.8% to 45.1%): three patients undergoing histological verification after chemotherapy had no evidence of malignancy.
CONCLUSION:
The study fails to demonstrate a response rate significantly >30%. The observation regarding M0 patients suggests to repeat this study in the neo-adjuvant setting.
AuthorsC Theodore, I Skoneczna, I Bodrogi, M Leahy, J M Kerst, L Collette, K Ven, S Marréaud, R D T Oliver, EORTC Genito-Urinary Tract Cancer Group
JournalAnnals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 19 Issue 7 Pg. 1304-1307 (Jul 2008) ISSN: 1569-8041 [Electronic] England
PMID18417462 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural)
Chemical References
  • Antineoplastic Agents
  • Antineoplastic Agents, Phytogenic
  • Irinotecan
  • Cisplatin
  • Camptothecin
Topics
  • Adult
  • Aged
  • Antineoplastic Agents (administration & dosage)
  • Antineoplastic Agents, Phytogenic (administration & dosage, adverse effects)
  • Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
  • Camptothecin (administration & dosage, analogs & derivatives)
  • Carcinoma, Squamous Cell (drug therapy, pathology)
  • Cisplatin (administration & dosage, adverse effects)
  • Drug Administration Schedule
  • Feasibility Studies
  • Follow-Up Studies
  • Humans
  • Irinotecan
  • Male
  • Middle Aged
  • Penile Neoplasms (drug therapy, pathology)
  • Time Factors
  • Treatment Outcome

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