NCT00066391

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
6 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2003

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

2.6 years

First QC Date

August 6, 2003

Last Update Submit

September 20, 2012

Conditions

Penile Cancer

Keywords

penile squamous cell carcinomastage III penile cancerstage IV penile cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • Duration of response as measured by Kaplan-Meier every 8 weeks until progression, and then every 3 months thereafter

  • Toxicity as measured by NCI-CTC v2.0 every 8 weeks until progression

Interventions

cisplatinDRUG
irinotecan hydrochlorideDRUG
neoadjuvant therapyPROCEDURE

Eligibility Criteria

AgeUp to 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (8)

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

National Institute of Oncology

Budapest, 1122, Hungary

Location

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, 02-781, Poland

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 18417462RESULT

MeSH Terms

Conditions

Penile Neoplasms

Interventions

CisplatinIrinotecanNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesPenile DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCamptothecinAlkaloidsHeterocyclic CompoundsCombined Modality TherapyTherapeutics

Study Officials

  • Christine Theodore, MD

    Gustave Roussy, Cancer Campus, Grand Paris

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2003

First Posted

August 7, 2003

Study Start

June 1, 2003

Primary Completion

January 1, 2006

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

NL(1)BE(1)FR(1)HU(1)PL(1)GB(3)