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A Phase II Study Of Estramustine, Docetaxel, And Bevacizumab (IND # 7921, NSC # 704865) In Men With Hormone Refractory Prostate Cancer

Phase 2
Not Enrolling
Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer

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Trial Information

A Phase II Study Of Estramustine, Docetaxel, And Bevacizumab (IND # 7921, NSC # 704865) In Men With Hormone Refractory Prostate Cancer


I. To determine time to objective progression, response rate (objective and PSA response)
and duration of response in men with hormone refractory prostate cancer treated with
estramustine, docetaxel and bevacizumab.

II. To determine the toxicity of this regimen in men with hormone refractory prostate

III. To study the relationship of baseline VEGF levels in urine and plasma and changes in
these levels to response and duration of response to treatment with bevacizumab, docetaxel
and estramustine.


Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour
followed by bevacizumab IV over 30-90 minutes on day 2. Treatment repeats every 21 days in
the absence of disease progression or unacceptable toxicity.

Patients are followed at least every 3 months for 2 years.

Inclusion Criteria:

- Patients must have histologically documented adenocarcinoma of the prostate with
progressive systemic (metastatic) disease despite castrate levels of testosterone due
to orchiectomy or LHRH agonist (which must be continued); castrate levels of
testosterone must be maintained

- At the time of enrollment, patients must have evidence of metastatic disease, either:

- Measurable disease (with any PSA) OR

- Non-measurable disease with PSA >= 5 ng/ml; patients with PSA >= 5 ng/ml only

- Any lesion that can be accurately measured in at least one dimension (longest
diameter to be recorded) as >= 20 mm with conventional techniques: 1) physical
exam for clinically palpable lymph nodes and superficial skin lesions, 2) chest
X-ray for clearly defined lung lesions surrounded by aerated lung OR those
lesions measured as >= 10 mm with a spiral CT scan or MRI

- Measurable lesions (up to a maximum of 10 in number) representative of all
organs involved to be identified as target lesions; the sum of the longest
diameters (LD) for all target lesions will be calculated and reported as
baseline sum LD

- If measurable disease is confined to a solitary lesion then its neoplastic
nature will need to be confirmed by histology

- Ultrasound may not be used to measure tumor lesions that are not easily

- Non-target lesions include all other lesions, including small lesions with
longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT
scan and truly non-measurable lesions, which include:

- Bone lesions

- Pleural or pericardial effusions, ascites

- CNS lesions, leptomeningeal disease

- Irradiated lesions, unless progression documented after RT

- Patients must have demonstrated evidence of progressive disease since the most recent
change in therapy; progressive disease is defined as any one of the following
(measurable disease, bone scan, or PSA progression):

- MEASURABLE DISEASE PROGRESSION: Objective evidence of increase > 20% in the sum
of the longest diameters (LD) of target lesions from the time of maximal
regression or the appearance of one or more new lesions

- BONE SCAN PROGRESSION: Appearance of one or more new lesions on bone scan
attributable to prostate cancer along with a PSA >= 5 ng/ml will constitute

- PSA PROGRESSION: An elevated PSA (at least >= 5 ng/ml) which has risen serially
from baseline on two occasions each at least one week apart. If the confirmatory
PSA (#3) value is less (i.e., #3b) than screening PSA (#2) value, then an
additional test for rising PSA (#4) will be required to document progression

- Failure despite standard androgen deprivation therapy

- Flutamide and megestrol acetate (any dose) must be discontinued at least 4 weeks
prior to registration; bicalutamide and nilutamide must be discontinued at least 6
weeks prior to registration. If improvement following antiandrogen withdrawal is
noted, progression must be established using the criteria above; primary testicular
androgen suppression (e.g., with an LHRH analogue) should not be discontinued

- At least 4 weeks since any hormonal therapy, including ketoconazole,
aminoglutethimide, systemic steroids (any dose), megestrol acetate (any dose)

- No prior cytotoxic chemotherapy, including estramustine or suramin

- No prior anti-angiogenesis agents, including thalidomide and bevacizumab

- >= 4 weeks since major surgery and fully recovered

- >= 4 weeks since any prior radiation and fully recovered

- >= 8 weeks since the last dose of strontium-89 or Samarium

- Patients receiving bisphosphonate therapy prior to initiating protocol treatment must
have received bisphosphonates for at least 1 month and have progressive disease
despite this therapy

- CTC (ECOG) performance status: 0-2

- No myocardial infarction or significant change in anginal pattern within one year or
current congestive heart failure (NYHA Class 2 or higher)

- No deep venous thrombosis or pulmonary embolus within one year. No need for full-dose
oral or parenteral anticoagulation; daily prophylactic aspirin is allowed

- No clinically significant peripheral neuropathy

- Granulocytes >= 1500/ul

- Platelet count >= 100,000/ul

- Creatinine =< 1.5 x upper limit of normal

- Bilirubin =< 1.0 x upper limit of normal

- AST =< 1.5 x upper limits of normal

- Urinalysis =< 1 + protein on dipstick

- PSA >= 5 ng/ml (if non-measurable disease)

- Serum Testosterone =< 50 ng/ml for patients who have not had bilateral orchiectomy

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to objective progression

Outcome Description:

The Kaplan-Meier method will be used to estimate the time to disease progression.

Outcome Time Frame:

From the initiation of treatment to the date of progressive disease, assessed up to 2 years

Safety Issue:


Principal Investigator

Joel Picus

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

June 2001

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Hormone-resistant Prostate Cancer
  • Recurrent Prostate Cancer
  • Stage IV Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms



Cancer and Leukemia Group B Chicago, Illinois  60606