Melanoma (Skin)Phase 2NCT00014625
E7070 in Treating Patients With Stage IV Melanoma
A Phase 2 study testing indisulam in people with Melanoma (Skin), run by European Organisation for Research and Treatment of Cancer - EORTC at 12 sites in 9 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of E7070 in treating patients who have stage IV melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- indisulam
- How many people
- 28 participants
- Where
- 12 sitesin 9 countries
- Study dates
- Feb 2001to Nov 2001
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed stage IV melanoma Metastatic disease At least 1 bidimensionally measurable target lesion by CT scan No brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR WHO 0-2 Life expectancy: Not specified Hematopoietic: Hemoglobin greater than 10 g/dL Neutrophil count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present) Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: Clinically normal cardiac function No history of severe or unstable ischemic heart disease 12-lead ECG normal Other: No history of unstable systemic disease No concurrent uncontrolled diabetes mellitus No concurrent infection No history of hypersensitivity to sulfonamides No other malignancy within the past 5 years except cone-biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer No psychological, familial, sociological, or geographical condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior blood transfusions At least 2 weeks since prior growth factors At least 6 weeks since prior experimental vaccine therapy No prior immunotherapy for metastatic disease No concurrent anticancer immunotherapy Chemotherapy: No prior chemotherapy for metastatic disease No other concurrent anticancer chemotherapy Endocrine therapy: No concurrent anticancer hormonal therapy Radiotherapy: No concurrent anticancer radiotherapy except palliation for pain control or other reasons (e.g., bronchial obstruction or ulcerating skin lesions) with no curative intent Surgery: Not specified Other: At least 6 weeks since prior adjuvant or neoadjuvant therapy At least 4 weeks since prior experimental drugs At least 2 weeks since prior and no concurrent coumarin anti-coagulants, terfenadine, cisapride, cyclosporine, tacrolimus, theophylline, diazepam, sulfonylurea anti-diabetics, phenytoin, or carbamazepine No other concurrent experimental agents
Trial locations and contacts
12 sites in 9 countries.
12 sites in 9 countries
France3 sites
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Leon Berard
Lyon, 69373
Centre Eugene Marquis
Rennes, 35064
United Kingdom2 sites
Western General Hospital
Edinburgh, Scotland, EH4 2XU
Royal Marsden NHS Trust
London, England, SW3 6JJ
Portugal1 site
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, 1093
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
About this study
Official title: Open Label Phase II Study Of E7070 In Patients With Metastatic Melanoma (Stage IV)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of E7070 in treating patients who have stage IV melanoma.
Read the detailed description
OBJECTIVES: I. Determine the therapeutic activity of E7070 in terms of objective response, duration of response, and progression-free survival of patients with metastatic melanoma. II. Determine the acute side effects of this drug in these patients. III. Determine the pharmacokinetic parameters of this drug in these patients.
OUTLINE: This is a multicenter study. Patients receive E7070 IV over 1 hour. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks.
PROJECTED ACCRUAL: A total of 19-24 patients will be accrued for this study.
- Conditions
- Melanoma (Skin)
- Being tested
- indisulam
- Keywords
- stage IV melanoma, recurrent melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indisulamDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2004 (estimated)
- Study startFeb 2001
- Primary completionNov 2001
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 Melanoma (Skin)Studies 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
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- John F. Smyth, MD, Study chair, Edinburgh Cancer Centre at Western General HospitalSteinar Aamdal, MD, PhD, Study chair, Norwegian Radium Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00014625
- Sponsor's protocol ID
- EORTC-16005-18002
- Other IDs
- EORTC-16005, EORTC-18002, EISAI-E7070-E044-205
- Status last verified
- Jul 2012
- First submitted
- 10 Apr 2001
- Last updated
- 24 Jul 2012
- Results posted
- No
Publications
Smyth JF, Aamdal S, Awada A, Dittrich C, Caponigro F, Schoffski P, Gore M, Lesimple T, Djurasinovic N, Baron B, Ravic M, Fumoleau P, Punt CJ; EORTC New Drug Development and Melanoma Groups. Phase II study of E7070 in patients with metastatic melanoma. Ann Oncol. 2005 Jan;16(1):158-61. doi: 10.1093/annonc/mdi016.
PubMed 15598954
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Phase II Study Of E7070 In Patients With Metastatic Melanoma (Stage IV)
- ClinicalTrials.gov ID
- NCT00014625
- Acronym / sponsor ID
- EORTC-16005-18002
- Conditions
- Melanoma (Skin)
- Keywords
- stage IV melanoma, recurrent melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Feb 2001
- Primary completion
- Nov 2001 (actual)
- First posted
- 16 Feb 2004 (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 use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of E7070 in treating patients who have stage IV melanoma.
Detailed description
OBJECTIVES: I. Determine the therapeutic activity of E7070 in terms of objective response, duration of response, and progression-free survival of patients with metastatic melanoma. II. Determine the acute side effects of this drug in these patients. III. Determine the pharmacokinetic parameters of this drug in these patients.
OUTLINE: This is a multicenter study. Patients receive E7070 IV over 1 hour. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks.
PROJECTED ACCRUAL: A total of 19-24 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| indisulam | Drug | – |
Primary outcome
Not reported in the source record.
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 Jul 2012.
- Results publication: PubMed 15598954Smyth JF, Aamdal S, Awada A, Dittrich C, Caponigro F, Schoffski P, Gore M, Lesimple T, Djurasinovic N, Baron B, Ravic M, Fumoleau P, Punt CJ; EORTC New Drug Development and Melanoma Groups. Phase II study of E7070 in patients with metastatic melanoma. Ann Oncol. 2005 Jan;16(1):158-61. doi: 10.1093/annonc/mdi016.
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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.
John F. Smyth, MD study chair
Edinburgh Cancer Centre at Western General Hospital
Steinar Aamdal, MD, PhD study chair
Norwegian Radium Hospital
12 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing indisulam in people with Melanoma (Skin), run by European Organisation for Research and Treatment of Cancer - EORTC at 12 sites in 9 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 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France, United Kingdom, Austria, Belgium, Germany and 4 more countries. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00014625, 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 Jul 2012.