Clinical trial NCT00014625: E7070 in Treating Patients With Stage IV Melanoma
Official title: Open Label Phase II Study Of E7070 In Patients With Metastatic Melanoma (Stage IV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma (Skin)
Keywords: stage IV melanoma
recurrent melanoma
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2004-02-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Kaiser Franz Josef Hospital
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Lyon
country: France
facility: Centre Leon Berard
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Naples
country: Italy
facility: Istituto Nazionale per lo Studio e la Cura dei Tumori
city: Oslo
country: Norway
facility: Norwegian Radium Hospital
city: Lisbon
country: Portugal
facility: Instituto Portugues de Oncologia de Francisco Gentil
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: London
country: United Kingdom
facility: Royal Marsden NHS Trust
state: England
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
state: Scotland
Study officials:
affiliation: Edinburgh Cancer Centre at Western General Hospital
name: John F. Smyth, MD
role: STUDY_CHAIR
affiliation: Norwegian Radium Hospital
name: Steinar Aamdal, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.