Penile CancerPhase 2NCT00066391
Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer
A Phase 2 study testing cisplatin, irinotecan hydrochloride and neoadjuvant therapy in people with Penile Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 8 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 75 years, men only
- Conditions the study is for
- Penile Cancer
- What is being tested?
- cisplatin, irinotecan hydrochloride and neoadjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 8 sitesin 6 countries
- Study dates
- Jun 2003to Jan 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
United Kingdom3 sites
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Netherlands1 site
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, 1066 CX
Poland1 site
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, 02-781
About this study
Official title: Phase II Study of Irinotecan (CPT 11) and Cisplatin (CDDP) in Metastatic or Locally Advanced Penile Carcinoma
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.
Read the 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.
- Conditions
- Penile Cancer
- Being tested
- cisplatin, irinotecan hydrochloride, neoadjuvant therapy
- Keywords
- penile squamous cell carcinoma, stage III penile cancer, stage IV penile cancer
- Medical subject headings
- Penile Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
neoadjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2003 (estimated)
- Study startJun 2003
- Primary completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Penile CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Christine Theodore, MD, Study chair, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066391
- Sponsor's protocol ID
- EORTC-30992
- Other IDs
- EORTC-30992
- Status last verified
- Sep 2012
- First submitted
- 6 Aug 2003
- Last updated
- 24 Sep 2012
- Results posted
- No
Publications
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.
PubMed 18417462
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Irinotecan (CPT 11) and Cisplatin (CDDP) in Metastatic or Locally Advanced Penile Carcinoma
- ClinicalTrials.gov ID
- NCT00066391
- Acronym / sponsor ID
- EORTC-30992
- Conditions
- Penile Cancer
- Keywords
- penile squamous cell carcinoma, stage III penile cancer, stage IV penile cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Jun 2003
- Primary completion
- Jan 2006 (actual)
- First posted
- 7 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatin | Drug | – |
| irinotecan hydrochloride | Drug | – |
| neoadjuvant therapy | Procedure or surgery | – |
Primary outcome
Objective response rate measured by RECIST at 8 weeks after completion of study treatment
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
- Results publication: PubMed 18417462Theodore 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Theodore, MD study chair
Gustave Roussy, Cancer Campus, Grand Paris
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin, irinotecan hydrochloride and neoadjuvant therapy in people with Penile Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, Belgium, France, Hungary, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate measured by RECIST at 8 weeks after completion of study treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00066391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012; AzTrials last refreshed its copy on 26 Oct 2026.