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Adenocarcinoma of the ProstatePhase 2NCT00016107

Combination Chemotherapy Plus Bevacizumab in Treating Patients With Metastatic Prostate Cancer

A Phase 2 study testing estramustine phosphate sodium, docetaxel and bevacizumab in people with Adenocarcinoma of the Prostate and Hormone-resistant Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase II trial to study the effectiveness of combination chemotherapy plus monoclonal antibody therapy in treating patients who have metastatic prostate cancer that has not responded to previous hormone therapy. Read more about this study

Who is it for?
Any age, men only
What is being tested?
estramustine phosphate sodium, docetaxel and bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteUnited States
Study dates
Jun 2001to Feb 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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 are not eligible DEFINITION OF MEASURABLE DISEASE/TARGET LESIONS
  • 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
Show all 38Show fewer
  • 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 accessible clinically DEFINITION OF NON-MEASURABLE DISEASE/NON-TARGET LESIONS
  • 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 progression
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cancer and Leukemia Group B

    Chicago, Illinois, 60606

Other trials in United States

About this study

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

Phase II trial to study the effectiveness of combination chemotherapy plus monoclonal antibody therapy in treating patients who have metastatic prostate cancer that has not responded to previous hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab may stop the growth of cancer cells by stopping blood flow to the tumor. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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 cancer.

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.

OUTLINE:

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.

Being tested
estramustine phosphate sodium, docetaxel, bevacizumab, laboratory biomarker analysis
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • estramustine phosphate sodiumDrug

    Also called EM, Emcyt, Estracyt, Ro 22-2296/000

    Given orally

  • docetaxelDrug

    Also called RP 56976, Taxotere, TXT

    Given IV

  • bevacizumabBiological

    Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00016107
Study groupRoleWhat they receive
Treatment (chemotherapy, bevacizumab)ExperimentalPatients 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.
Receives: Drug: estramustine phosphate sodium; Drug: docetaxel; Biological: bevacizumab; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to objective progression

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

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

  2. Response rates (PSA and objective)

    Response rates will be analyzed using both objective (CR and PR) and serological parameters. The Kaplan-Meier method will be used to estimate the response (objective and PSA) duration.

    Measured: Up to 2 years

  3. Toxicity as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 2.0

    Measured: Up to 2 years

Secondary outcomes (2)

  1. Overall survival

    The Kaplan-Meier method will be used to estimate the overall survival.

    Measured: Up to 2 years

  2. Duration of response

    Duration of PSA response is the date from the first 50% decline (or 75% decline) in PSA to the date when the patient met the criteria for progressive disease.

    Measured: From the date of the first CR or PR to the date that the patient had progressive disease, assessed up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2003 (estimated)
  2. Study startJun 2001
  3. Primary completionFeb 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00016107
Sponsor's protocol ID
NCI-2012-02962
Other IDs
CALGB-90006, CDR0000068595, U10CA031946
Status last verified
Jun 2013
First submitted
6 May 2001
Last updated
5 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing estramustine phosphate sodium, docetaxel and bevacizumab in people with Adenocarcinoma of the Prostate and Hormone-resistant Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 38 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to objective progression (time frame: From the initiation of treatment to the date of progressive disease, assessed up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00016107.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013.

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