E7070 in Treating Patients With Stage IV Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00014625
First received: April 10, 2001
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Drug: indisulam
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Open Label Phase II Study Of E7070 In Patients With Metastatic Melanoma (Stage IV)

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 28
Study Start Date: February 2001
Primary Completion Date: November 2001 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00014625

Locations
Austria
Kaiser Franz Josef Hospital
Vienna, Austria, A-1100
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
France
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Centre Leon Berard
Lyon, France, 69373
Centre Eugene Marquis
Rennes, France, 35064
Germany
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, Italy, 80131
Norway
Norwegian Radium Hospital
Oslo, Norway, N-0310
Portugal
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, Portugal, 1093
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
United Kingdom
Royal Marsden NHS Trust
London, England, United Kingdom, SW3 6JJ
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: John F. Smyth, MD Edinburgh Cancer Centre at Western General Hospital
Study Chair: Steinar Aamdal, MD, PhD Norwegian Radium Hospital
  More Information

Additional Information:
Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00014625     History of Changes
Other Study ID Numbers: EORTC-16005-18002, EORTC-16005, EORTC-18002, EISAI-E7070-E044-205
Study First Received: April 10, 2001
Last Updated: July 23, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 23, 2014