Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

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: NCT00039429
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 28, 2010
National Cancer Institute (NCI)
Information provided by:
Eastern Cooperative Oncology Group

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well atrasentan works in treating patients with locally recurrent or metastatic kidney cancer.

Condition or disease Intervention/treatment Phase
Kidney Cancer Drug: atrasentan hydrochloride Phase 2

Detailed Description:


  • Determine the 6-month progression-free survival rate, in terms of proportion of those with measurable disease or bone metastases only, of patients with locally recurrent or metastatic renal cell carcinoma treated with atrasentan (measurable disease stratum closed to accrual as of 7/16/04).
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior immunotherapy/biologic therapy (yes vs no) and characteristic of disease (measurable vs bone metastases only) (measurable disease stratum closed to accrual as of 7/16/04).

Patients receive oral atrasentan once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 180 patients (90 per stratum [with or without prior therapy]) will be accrued for this study within 6 months (based on prior accrual, the bone metastases only group [specifically patients who have received 1 prior therapy] is the only stratum open for accrual).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Evaluating Atrasentan In Patients With Advanced Renal Cell Carcinoma
Study Start Date : May 2003
Actual Primary Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Progression-free survival at 6 months
  2. Toxicity

Information from the National Library of Medicine

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


  • Histologically confirmed locally recurrent or metastatic renal cell carcinoma that is not amenable to resection
  • Progressive disease, defined by 1 of the following:

    • The appearance of 1 or more new lesions
    • At least a 20% increase in the sum of the longest diameters of the target lesions (taking as a reference the smallest sum of the longest diameters recorded since the baseline measurements) (measurable disease stratum closed to accrual as of 7/16/04.)
  • One of the following disease characteristics:

    • Disease manifested solely by bone metastases
    • At least 1 measurable lesion (measurable disease stratum closed to accrual as of 7/16/04.)

      • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • No prior or concurrent brain metastases



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • WBC at least 2,000/mm^3 OR
  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL


  • Bilirubin less than 1.5 mg/dL
  • AST and/or ALT less than 1.5 times upper limit of normal (ULN)


  • Creatinine less than 1.5 times ULN


  • No history of New York Heart Association class II-IV heart disease


  • No significant pulmonary disease requiring pulse steroid therapy within the past 3 months


  • No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No other serious concurrent medical illness that would preclude study participation
  • No active infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • At least 4 weeks since prior biologic therapy/immunotherapy and recovered
  • No more than 1 prior regimen* of biologic therapy/immunotherapy (e.g., interleukin-2, interferon, thalidomide, or combination)

    • Prior sargramostim (GM-CSF) is not counted as prior biological therapy NOTE: *A regimen is considered to be at least 4 weeks of treatment


  • No prior chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior hormonal agents (e.g., megestrol or tamoxifen) and recovered


  • At least 4 weeks since prior radiotherapy and recovered
  • Prior radiotherapy for local control or palliation of painful bony lesion allowed
  • No prior radiotherapy to target lesions
  • No concurrent radiotherapy for palliation or any other indication


  • At least 4 weeks since prior surgery and recovered
  • Prior nephrectomy allowed


  • Prior bisphosphonates allowed

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): NCT00039429

  Show 177 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Michael A. Carducci, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications of Results:
Manola J, Carducci M, Nair S, et al.: Phase II ECOG trial of atrasentan in advanced renal cell carcinoma. [Abstract] J Clin Oncol 25 (Suppl 18): A-5102, 260s, 2007.

Responsible Party: Group Chair, Eastern Cooperative Oncology Group Identifier: NCT00039429     History of Changes
Other Study ID Numbers: CDR0000069382
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 28, 2010
Last Verified: January 2010

Keywords provided by Eastern Cooperative Oncology Group:
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action