Intravenous or Hepatic Arterial Infusion of Fotemustine in Treating Patients With Unresectable Liver Metastases From Eye Melanoma
This study has been terminated.
(low accrual)
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:
NCT00110123
First received: May 3, 2005
Last updated: September 20, 2012
Last verified: September 2012
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Purpose
RATIONALE: Drugs used in chemotherapy, such as fotemustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different ways may kill more tumor cells. It is not yet known whether giving fotemustine as an intravenous infusion is more effective than giving it as a hepatic arterial infusion in treating liver metastases.
PURPOSE: This randomized phase III trial is studying intravenous infusion of fotemustine to see how well it works compared to hepatic arterial infusion of fotemustine in treating patients with unresectable liver metastases from eye melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Intraocular Melanoma Metastatic Cancer |
Drug: fotemustine Drug: isolated perfusion |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intravenous Versus Intra-Arterial Fotemustine Chemotherapy in Patients With Liver Metastases From Uveal Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group |
Resource links provided by NLM:
Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:
Primary Outcome Measures:
- Duration of survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival [ Designated as safety issue: No ]
- Best response as assessed by RECIST criteria [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Toxicity as assessed by CTCAE v3 [ Designated as safety issue: Yes ]
| Enrollment: | 171 |
| Study Start Date: | January 2005 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Compare overall survival of patients with surgically incurable or unresectable liver metastases secondary to uveal melanoma treated with fotemustine administered as an intravenous infusion vs an intra-arterial hepatic perfusion.
Secondary
- Compare progression-free survival of patients treated with this drug.
- Compare the response rate in patients treated with this drug.
- Compare the duration of objective response in patients treated with this drug.
- Compare the patterns of progression in patients treated with this drug.
- Compare treatment-related toxic effects and catheter-related complications in patients treated with this drug.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to participating center, lactic dehydrogenase level (normal vs abnormal), and WHO performance status (0 vs 1 vs 2). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive fotemustine IV over 1 hour on days 1, 8, and 15 (induction course). Beginning on day 50, patients receive maintenance courses of fotemustine IV over 1 hour every 21 days in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive fotemustine by a 4-hour intra-arterial (IA) hepatic perfusion on days 1, 8, 15, and 22 (induction course). Beginning on day 57, patients receive maintenance courses of fotemustine by a 4-hour IA hepatic perfusion every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 9 weeks for survival.
PROJECTED ACCRUAL: A total of 262 patients (131 per treatment arm) will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed liver metastases secondary to uveal melanoma
- Surgically incurable or unresectable disease
- No detectable extrahepatic metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- WHO 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 2,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
Hepatic
- Bilirubin < 1.5 times upper limit of normal (ULN)
- ALT and AST < 5 times ULN
- Alkaline phosphatase < 5 times ULN
- Gamma-glutamyltransferase < 5 times ULN
- Lactic dehydrogenase < 5 times ULN
Renal
- BUN < 1.5 times ULN
- Creatinine ≤ 1.5 times ULN
Cardiovascular
- No uncontrolled angina pectoris
- No myocardial infarction within the past 6 months
- No uncontrolled high blood pressure
- No evolutive intracranial hypertension
- No other severe cardiac disease
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active gastroduodenal ulcer
- No diabetes
- No active or uncontrolled infection
- No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
- No other uncontrolled severe medical condition
- No other malignancy within the past 5 years except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunologic or biologic therapy
Chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy for metastatic disease
- No concurrent radiotherapy
Surgery
- Recovered from prior major surgery
Other
- No prior antineoplastic drugs for metastatic disease
- More than 4 weeks since prior investigational drugs
- No other concurrent anticancer agents or therapies
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110123
Locations
| Italy | |
| European Institute of Oncology | |
| Milan, Italy, 20141 | |
| Istituto Nazionale per lo Studio e la Cura dei Tumori | |
| Naples, Italy, 80131 | |
| Azienda Ospedaliera di Padova | |
| Padova, Italy, 35128 | |
| Universita di Siena | |
| Siena, Italy, 53100 | |
| Poland | |
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw | |
| Warsaw, Poland, 02-781 | |
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois | |
| Lausanne, Switzerland, CH-1011 | |
| United Kingdom | |
| Clatterbridge Centre for Oncology | |
| Merseyside, England, United Kingdom, CH63 4JY | |
| Ninewells Hospital | |
| Dundee, Scotland, United Kingdom, DD1 9SY | |
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
| Study Chair: | Serge Leyvraz, MD | Centre Hospitalier Universitaire Vaudois |
More Information
Additional Information:
No publications provided by European Organisation for Research and Treatment of Cancer - EORTC
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00110123 History of Changes |
| Other Study ID Numbers: | EORTC-18021, EORTC-18021, 2004-002245-12 |
| Study First Received: | May 3, 2005 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
liver metastases ciliary body and choroid melanoma, medium/large size iris melanoma |
extraocular extension melanoma recurrent intraocular melanoma metastatic intraocular melanoma |
Additional relevant MeSH terms:
|
Melanoma Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Uveal Neoplasms Liver Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas Neoplastic Processes |
Pathologic Processes Eye Neoplasms Neoplasms by Site Eye Diseases Uveal Diseases Digestive System Neoplasms Digestive System Diseases Liver Diseases Fotemustine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013