Clinical trial NCT00046943: Atrasentan in Treating Patients With Prostate Cancer
Official title: A Phase III Extension Study to Evaluate the Safety of 10 mg Atrasentan in Men With Hormone-Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
recurrent prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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

PURPOSE: Phase III trial to determine the effectiveness of atrasentan in treating patients who have prostate cancer that has not responded to hormone therapy.

Detailed description: OBJECTIVES:

* Determine the safety of atrasentan in patients with hormone-refractory prostate cancer.
* Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral atrasentan once daily for 3 years in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month and then every 3 months for 2 years.

PROJECTED ACCRUAL: Approximately 1,400 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of hormone-refractory prostate cancer
* Completed protocol ABBOTT-M00-211 or ABBOTT-M00-244 within the past 30 days

  * Disease progression OR
  * Active in trial when double-blind treatment period ended

PATIENT CHARACTERISTICS:

Age

* 19 and over

Performance status

* Karnofsky 60-100%

Life expectancy

* Not specified

Hematopoietic

* WBC at least 3,000/mm3
* 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 ALT no greater than 1.5 times upper limit of normal

Renal

* Creatinine clearance at least 40 mL/min

Cardiovascular

* No New York Heart Association class II-IV heart disease

Pulmonary

* No significant pulmonary disease requiring chronic or pulse steroid therapy within the past 3 months

Other

* Fertile patients must use 2 effective methods of contraception (1 must be barrier contraception) during and for 8 weeks after study
* No reason that would preclude study
* No significant comorbid condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* At least 4 weeks since other prior cytotoxic chemotherapy
* No other concurrent cytotoxic chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* At least 4 weeks since prior radionuclides
* No concurrent radionuclides

Surgery

* Not specified

Other

* At least 4 weeks since prior investigational agents
* No concurrent antiretroviral therapy for HIV-positive patients
* No concurrent participation in another investigational study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
Study officials:
affiliation: Abbott
name: Gary Gordon, MD, PhD
References: