Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer
This study has been completed.
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00066391
First received: August 6, 2003
Last updated: September 20, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Penile Cancer |
Drug: cisplatin Drug: irinotecan hydrochloride Procedure: neoadjuvant therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Irinotecan (CPT 11) and Cisplatin (CDDP) in Metastatic or Locally Advanced Penile Carcinoma |
Resource links provided by NLM:
Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:
Primary Outcome Measures:
- Objective response rate measured by RECIST at 8 weeks after completion of study treatment [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Duration of response as measured by Kaplan-Meier every 8 weeks until progression, and then every 3 months thereafter [ Designated as safety issue: No ]
- Toxicity as measured by NCI-CTC v2.0 every 8 weeks until progression [ Designated as safety issue: Yes ]
| Study Start Date: | June 2003 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066391
Locations
| Belgium | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| France | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
| Hungary | |
| National Institute of Oncology | |
| Budapest, Hungary, 1122 | |
| Netherlands | |
| Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | |
| Amsterdam, Netherlands, 1066 CX | |
| Poland | |
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | |
| Warsaw, Poland, 02-781 | |
| United Kingdom | |
| Bristol Haematology and Oncology Centre | |
| Bristol, England, United Kingdom, BS2 8ED | |
| Leeds Cancer Centre at St. James's University Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Saint Bartholomew's Hospital | |
| London, England, United Kingdom, EC1A 7BE | |
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
| Study Chair: | Christine Theodore, MD | Institut Gustave Roussy |
More Information
Additional Information:
Publications:
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00066391 History of Changes |
| Other Study ID Numbers: | EORTC-30992, EORTC-30992 |
| Study First Received: | August 6, 2003 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
penile squamous cell carcinoma stage III penile cancer stage IV penile cancer |
Additional relevant MeSH terms:
|
Penile Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Penile Diseases Irinotecan Cisplatin Camptothecin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013