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

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase

Completed

Phase 2

Conditions

Penile Cancer

Treatments

Procedure: neoadjuvant therapy

Drug: irinotecan hydrochloride

Drug: cisplatin

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00066391

EORTC-30992

Details and patient eligibility

About

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.

Full 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.

Sex

Male

Ages

Under 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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