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Phase II Study of Weekly Paclitaxel and Bryostatin-1 in Hormone Refractory Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Phase II Study of Weekly Paclitaxel and Bryostatin-1 in Hormone Refractory Prostate Cancer


OBJECTIVES:

I. Determine the onset, duration, and degree of response in patients with
hormone-refractory, metastatic adenocarcinoma of the prostate treated with paclitaxel and
bryostatin 1.

II. Determine the toxicity of this regimen in these patients. III. Determine the overall
survival of patients treated with this regimen.

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

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1
hour on days 2, 9, and 16. Treatment repeats every 4 weeks in the absence of disease
progression or unacceptable toxicity.

Patients are followed monthly for 6 months and then every 3 months thereafter.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic adenocarcinoma of the prostate that failed first-
or second-line hormonal therapy (e.g., gonadal androgen suppression [orchiectomy or
luteinizing hormone-releasing hormone] with or without antiandrogens)

- Failure on hormonal therapy is defined by 1 of the following criteria:

- Biochemical progression (after withdrawal of antiandrogens), documented by
3 rising PSA values, each value measured at least 2 weeks apart, with the
last measurement being at least 25% of the nadir achieved while on hormonal
therapy and with an increase in the absolute value by at least 5 ng/mL

- Measurable disease progression, defined by an increase in the sum of the
products of the perpendicular diameters of any measurable lesion(s) by at
least 25%

- Bone only progression allowed only with concurrent biochemical progression

- Castrate levels of testosterone (no greater than 50 ng/dL)

- No clinical signs/symptoms suggesting CNS metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- More than 6 months

Hematopoietic

- WBC at least 3,000/mm^3

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST/ALT no greater than 2.5 times ULN

Renal

- Creatinine no greater than 1.5 times ULN

- Calcium no greater than ULN

Cardiovascular

- No uncontrolled or severe cardiovascular disease

- No myocardial infarction within the past 6 months

- No congestive heart failure

- No angina pectoris

- No active thromboembolic events within the past 3 months (e.g., deep venous
thrombosis or cerebrovascular accident)

Other

- No other serious medical or psychiatric illness

- No active infection

- No dementia or significantly altered mental status

- No prior or concurrent grade 1 or greater peripheral neuropathy

- No other prior or concurrent malignancy within the past 5 years except curatively
treated nonmelanoma skin cancer

- HIV negative

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Chemotherapy

- No prior chemotherapy (including paclitaxel)

Endocrine therapy

- At least 4 weeks since prior steroids or megestrol

Radiotherapy

- At least 4 weeks since prior radiotherapy to bone lesions

Other

- No other concurrent investigational therapy

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Arif Hussain, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000067549

NCT ID:

NCT00005028

Start Date:

May 2000

Completion Date:

Related Keywords:

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

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Greater Baltimore Medical Center and Cancer CenterBaltimore, Maryland  21204
Wellspan Health - York Cancer CenterYork, Pennsylvania  17403