Clinical trial NCT00066391: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Penile Cancer
Keywords: penile squamous cell carcinoma
stage III penile cancer
stage IV penile cancer
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2003-08-07
Sex: MALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective response rate measured by RECIST at 8 weeks after completion of study treatment
Secondary outcomes:
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
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: U.Z. Gasthuisberg
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Budapest
country: Hungary
facility: National Institute of Oncology
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
state: England
city: Leeds
country: United Kingdom
facility: Leeds Cancer Centre at St. James's University Hospital
state: England
city: London
country: United Kingdom
facility: Saint Bartholomew's Hospital
state: England
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Christine Theodore, MD
role: STUDY_CHAIR
References:
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.