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Open Label Phase II Study Of E7070 In Patients With Metastatic Melanoma (Stage IV)

Phase 2
18 Years
Not Enrolling
Melanoma (Skin)

Thank you

Trial Information

Open Label Phase II Study Of E7070 In Patients With Metastatic Melanoma (Stage IV)

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.

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

John F. Smyth, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Edinburgh Cancer Centre at Western General Hospital


United States: Federal Government

Study ID:




Start Date:

February 2001

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma