Know Cancer

or
forgot password

A Phase III Extension Study to Evaluate the Safety of 10 mg Atrasentan in Men With Hormone-Refractory Prostate Cancer


Phase 3
19 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase III Extension Study to Evaluate the Safety of 10 mg Atrasentan in Men With Hormone-Refractory Prostate Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Gary Gordon, MD, PhD

Investigator Affiliation:

Abbott

Authority:

United States: Federal Government

Study ID:

CDR0000257127

NCT ID:

NCT00046943

Start Date:

September 2002

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781