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A Safety, Tolerability and Efficacy Study of E7070 in Patients With Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00059735
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : March 5, 2008
Information provided by:
Eisai Inc.

Brief Summary:
The purpose of this study is to determine if E7070 is a safe and effective treatment for cancer of the kidneys.

Condition or disease Intervention/treatment Phase
Kidney Neoplasms Carcinoma, Renal Cell Adenocarcinoma, Renal Cell Drug: E7070 Phase 2

Detailed Description:
Renal Cell Carcinoma (RCC) accounts for approximately 2% of all cancers and its incidence is increasing with worldwide deaths of over 100,000 patients per year. About 50% of RCC patients have inoperable or metastatic disease that surgery cannot be performed on. RCC is also considered to be resistant to both radiotherapy and cytotoxic chemotherapy. The purpose of this study is to evaluate the safety and effectiveness of E7070 by assessing progression free survival, tumor response rate, duration of response/stable disease, and survival time. E7070 will be administered as a single iv infusion over 60 minutes on Day 1 of each cycle. Patients will continue treatment with E7070 until they no longer have clinical benefit and have disease progression, or toxicity leads to patient withdrawal.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of E7070 in Patients With Progressive Inoperable and/or Metastatic Renal Cell Carcinoma (RCC)
Study Start Date : May 2002
Actual Study Completion Date : December 2003

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age >=18 years old.
  • Have histologically/cytologically confirmed clear cell RCC.
  • Previously untreated or one prior treatment with immunotherapy (one prior treatment may be represented by single agent interferon, single agent interleukin-2 or a combination of interferon with interleukin-2 with or without accompanying hematological growth factors).
  • Documented evidence of progressive disease in the previous 3 months. In the absence of radiographic studies, patients may be entered on the study if they have clinical evidence of progressive disease.
  • Have at least one unidimensional measurable lesion of RCC according to the RECIST guidelines. The following will not qualify as measurable lesions: bone, leptomeningeal disease, ascites, pleural/pericardial effusion, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, and cystic lesions.
  • Be ambulatory and have a Karnofsky performance status >=70%.
  • Have a life expectancy of at least 3 months.
  • Give written informed consent prior to any study-specific screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.
  • Be willing and able to comply with the study protocol for the duration of the study.

Exclusion Criteria:

  • Woman who are pregnant or breastfeeding. Women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate contraceptive measures (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
  • Fertile male subjects not willing to use contraception and whose female partners are not under adequate contraceptive protection.
  • Known CNS metastases (if clinical suspicion of CNS metastases exists appropriate imaging must be performed prior to study entry).
  • Prior treatment with chemotherapy (there is no restriction on prior epidermal growth factor directed therapy).
  • Severe and uncontrolled cardiac or cardiovascular abnormalities.
  • Severe uncontrolled intercurrent infections.
  • Subjects with organ allografts.
  • Any of the following abnormal screening hematological values: Hemoglobin (Hb) <9g /dL (6 mmol/L), Neutrophils <1.5 x 10^9/L, Platelets <100 x 10^9/L.
  • Blood transfusions or growth factors to aid hematological recovery within 2 weeks prior to starting study treatment.
  • Any of the following abnormal screening liver function tests: serum bilirubin >= 1.5 x upper normal limit (ULN), alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) >= 2.5 x ULN (unless related to liver metastases in which case >= 5 x ULN).
  • The following abnormal screening renal function tests: either a serum creatinine > 1.5 x ULN or a creatinine clearance (estimated from serum creatinine) < 40 mL/minute.
  • Prior radiotherapy (except palliative).
  • Participation in any investigational drug study or immunotherapy within 4 weeks preceding treatment start.
  • History of hypersensitivity to sulphonamides.
  • Any concurrent or previous malignancy of a different tumor type within 5 years of starting E7070 treatment except for adequately treated non-melanoma skin cancer or cervical intra-epithelial neoplasia.
  • Significant disease, which in the Investigator's opinion would exclude the patient from the study.
  • Surgically resectable metastatic disease.
  • Legal incapacity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00059735

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United States, California
Sacramento, California, United States, 95817
United States, New York
Bronx, New York, United States, 10466
New York, New York, United States, 10021
New York, New York, United States, 10032
Villejuif Cedex, France, 94805
Sponsors and Collaborators
Eisai Inc.
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Study Director: Murray Yule, MRCP, PhD Eisai Limited
Additional Information:
Layout table for additonal information Identifier: NCT00059735    
Other Study ID Numbers: E7070-A001-206
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: March 5, 2008
Last Verified: February 2008
Keywords provided by Eisai Inc.:
kidney cancer
kidney neoplasms
renal cell cancer
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action