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A Phase II Trial Evaluating Atrasentan In Patients With Advanced Renal Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Kidney Cancer

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Trial Information

A Phase II Trial Evaluating Atrasentan In Patients With Advanced Renal Cell Carcinoma


- 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).

Inclusion Criteria


- 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

- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT

- 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


- 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


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 6 months

Safety Issue:


Principal Investigator

Michael A. Carducci, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2003

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



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