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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

cisplatin

irinotecan hydrochloride

neoadjuvant therapy

About this trial

This is an interventional treatment trial for Penile Cancer focused on measuring penile squamous cell carcinoma, stage III penile cancer, stage IV penile cancer

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

U.Z. Gasthuisberg
Institut Gustave Roussy
National Institute of Oncology
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Bristol Haematology and Oncology Centre
Leeds Cancer Centre at St. James's University Hospital
Saint Bartholomew's Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00066391

First Posted

August 6, 2003

Last Updated

September 20, 2012

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

1. Study Identification

Unique Protocol Identification Number

NCT00066391

Brief Title

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

Official Title

Phase II Study of Irinotecan (CPT 11) and Cisplatin (CDDP) in Metastatic or Locally Advanced Penile Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

June 2003 (undefined)

Primary Completion Date

January 2006 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Penile Cancer

Keywords

penile squamous cell carcinoma, stage III penile cancer, stage IV penile cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Type

Drug

Intervention Name(s)

irinotecan hydrochloride

Intervention Type

Procedure

Intervention Name(s)

neoadjuvant therapy

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

Male

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christine Theodore, MD

Organizational Affiliation

Gustave Roussy, Cancer Campus, Grand Paris

Official's Role

Study Chair

Facility Information:

Facility Name

U.Z. Gasthuisberg

City

Leuven

ZIP/Postal Code

B-3000

Country

Belgium

Facility Name

Institut Gustave Roussy

City

Villejuif

ZIP/Postal Code

F-94805

Country

France

Facility Name

National Institute of Oncology

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

City

Warsaw

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Bristol Haematology and Oncology Centre

City

Bristol

State/Province

England

ZIP/Postal Code

BS2 8ED

Country

United Kingdom

Facility Name

Leeds Cancer Centre at St. James's University Hospital

City

Leeds

State/Province

England

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

Saint Bartholomew's Hospital

City

London

State/Province

England

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

18417462

Citation

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.

Results Reference

result

Penile Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial