Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI ECOG-E6800 E6800, NCT00039429

Objectives

1. 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).
2. Determine the toxicity of this drug in these patients.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

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]

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

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

Radiotherapy:

• 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

Surgery:

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

Other:

• Prior bisphosphonates allowed

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 2,000/mm³

  OR

• Absolute neutrophil count greater than 1,000/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 9 g/dL

Hepatic:

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

Renal:

• Creatinine less than 1.5 times ULN

Cardiovascular:

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

Pulmonary:

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

Other:

• 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

Expected Enrollment

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).

Outcomes

Progression-free survival at 6 months
Toxicity

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.

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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Michael Carducci, MD, Protocol chair		Ph: 410-614-3977 Email: carducci@welchlink.welch.jhu.edu

Registry Information
Official Title		A Phase II Trial Evaluating Atrasentan In Patients With Advanced Renal Cell Carcinoma
Trial Start Date		2003-05-22
Registered in ClinicalTrials.gov		NCT00039429
Date Submitted to PDQ		2002-04-19
Information Last Verified		2006-07-03
NCI Grant/Contract Number		CA21115

Back to Top