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Adenocarcinoma of the ProstatePhase 2NCT00527124

Docetaxel and Prednisone With or Without Cediranib in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

A Phase 2 study testing cediranib maleate, docetaxel and prednisone in people with Adenocarcinoma of the Prostate and Stage IV Prostate Cancer, run by National Cancer Institute (NCI) at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This randomized phase II trial is studying how well giving docetaxel and prednisone together with or without cediranib works in treating patients with metastatic prostate cancer that did not respond to hormone therapy. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
cediranib maleate, docetaxel and prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
4 sitesUnited States
Study dates
Nov 2007to Nov 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical/radiologic metastases with objective evidence of disease progression by imaging or by rising prostate-specific antigen (PSA) despite androgen deprivation therapy
  • Rising PSA must be determined based on a rising trend with 2 successive elevations at a minimum interval of 1 week
  • Meets 1 of the following criteria: Measurable disease, with any level of PSA, at least 1 unidimensionally measurable lesion (longest diameter to be recorded) >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan, nonmeasurable disease, PSA >= 5 ng/mL OR new areas of bony metastases on bone scan
  • Castrate levels of testosterone < 50 ng/dL must be maintained and documented
  • Luteinizing hormone-releasing hormone (LHRH) agonist therapy must be continued, if required to maintain castrate levels of testosterone
  • Total bilirubin normal
Show all 38Show fewer
  • Patients with radiological evidence of stable brain metastases are eligible provided they are asymptomatic and do not require corticosteroids or have been treated with corticosteroids and show clinical and radiological evidence of stabilization at least 10 days after discontinuation of steroids
  • ECOG performance status (PS) =< 2 or Karnofsky PS 60-100%
  • Life expectancy > 12 weeks
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Platelet count >= 100,000/mcL
  • Histologically confirmed adenocarcinoma of the prostate
  • AST and ALT =< 2.5 times upper limit of normal
  • Creatinine normal OR creatinine clearance >= 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Proteinuria =< 1+ and urine protein:creatinine ratio =< 1.0 OR 24-hour urine protein < 1,000 mg
  • Peripheral neuropathy >= grade 2
  • Uncontrolled intercurrent illness including, but not limited to, any of the following: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations that would limit compliance with study requirements
  • Congestive heart failure, second or third degree heart block, or recent myocardial infarction within the past 6 months
  • QTc prolongation > 500 msec OR other ECG abnormality noted within 14 days of treatment
  • New York Heart Association class III or IV cardiac disease; Class II disease controlled with treatment and monitoring allowed
  • History of poorly controlled hypertension (e.g., resting blood pressure > 150/90 mm Hg with or without hypertensive therapy)
  • History of a curatively treated malignancy with a survival prognosis of less than 5 years or concurrent malignancy except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ
  • History of significant gastrointestinal impairment, as judged by the investigator, that would significantly affect the absorption of cediranib
  • History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • Significant hemorrhage (30 mL bleeding/episode in previous 3 months) or hemoptysis (5 mL fresh blood in previous 4 weeks)
  • Prior enrollment or randomization of treatment in the present study
  • Patients must be off flutamide antiandrogen therapy for ≥ 4 weeks (6 weeks for bicalutamide or nilutamide)
  • No prior chemotherapy for metastatic prostate cancer
  • No major surgery within the past 14 days or a surgical incision that is not fully healed
  • No HIV-positive patients on combination antiretroviral therapy
  • No conditions requiring concurrent use of drugs or biologics with proarrhythmic potential
  • No other investigational agents within 30 days prior to study enrollment
  • No untreated unstable brain or meningeal metastases
  • Known hypersensitivity to cediranib or any of its excipients

Who cannot join

None listed.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Wayne State University

    Detroit, Michigan, 48202

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: A Randomized, Phase II Trial of AZD2171, Docetaxel, and Prednisone Compared to Docetaxel and Prednisone in Patients With Metastatic, Hormone Refractory Prostate Cancer

This randomized phase II trial is studying how well giving docetaxel and prednisone together with or without cediranib works in treating patients with metastatic prostate cancer that did not respond to hormone therapy. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving docetaxel together with prednisone, with or without cediranib, may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the 6-month progression-free survival rate of patients with hormone refractory metastatic adenocarcinoma of the prostate treated with docetaxel and prednisone with vs without cediranib.

SECONDARY OBJECTIVES:

  1. To evaluate the safety profile of cediranib, docetaxel, and prednisone in patients with metastatic hormone-refractory prostate cancer.

II. To determine the duration of prostate-specific antigen (PSA) response and PSA control in patients with metastatic hormone-refractory prostate cancer treated with cediranib, docetaxel, and prednisone.

III. To determine the partial and complete response rate in patients with measurable disease treated with cediranib, docetaxel, and prednisone.

IV. To determine time to progression in patients with metastatic hormone-refractory prostate cancer treated with cediranib, docetaxel, and prednisone.

  1. To determine overall survival in patients with metastatic hormone-refractory prostate cancer.

VI. To perform correlative marker studies measuring serum levels of VEGF, PDGF, sICAM, bFGF, interleukin (IL)-6, and IL-8.

VII. To perform a pilot study of [F18]FMAU positron emission test (PET) imaging on patients receiving cediranib, docetaxel, and prednisone.

OUTLINE: This is a multicenter study. Patients are stratified by participating institution. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.

ARM II: Patients receive docetaxel and prednisone as in arm I.

In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Archival paraffin-embedded tissue blocks or slides from time of diagnosis (or subsequent, but prior to therapy) are evaluated for expression of molecular targets relevant to this study. Blood specimens from baseline, after courses 1 and 2, and after completion of study treatment are analyzed for protein markers. Samples are analyzed by ELISA and IHC for angiogenesis-associated plasma proteins, plasma levels of VEGF, tumor expression of PDGFR, and interleukin (IL)-6 and IL-8 plasma levels. Patients also undergo positron emission test (PET) scans utilizing fluorodeoxyglucose (FDG) at baseline and after course 1.

After completion of study treatment, patients are followed every 3 months for 52 weeks.

Being tested
cediranib maleate, docetaxel, prednisone, 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.

  • cediranib maleateDrug

    Also called AZD2171, Recentin

    Given orally

  • docetaxelDrug

    Also called RP 56976, Taxotere, TXT

    Given IV

  • prednisoneDrug

    Also called DeCortin, Deltra

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00527124
Study groupRoleWhat they receive
Arm IExperimentalPatients receive oral cediranib maleate once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
Receives: Drug: cediranib maleate; Drug: docetaxel; Drug: prednisone; Other: laboratory biomarker analysis
Arm IIActive comparatorPatients receive docetaxel and prednisone as in arm I.
Receives: Drug: docetaxel; Drug: prednisone; Other: laboratory biomarker analysis

What is being measured

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

  1. 6-month Progression-free Survival (PFS) Proportion

    The proportion of patients on each treatment arm who survive ≥ 6.00 months progression-free

    Measured: Followed for 52 weeks at 3 month intervals after coming off treatment, time period equal to the length of treatment + up to 12 months

Secondary outcomes (4)

  1. Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group

    PSA < 4.0 ng/ml. is a CR. A 50% decline or better in PSA is a PR. Less than a 50% decline in PSA and less than a 25% increase in PSA is SD. A 25% or greater increase in PSA level by at least 5 ng/mL is PD by PSA only. The point estimate and 95% Wilson CI estimates of the proportion for the Prostate-specific antigen (PSA) response will be computed .

    Measured: Up to 52 weeks

  2. Overall Response Rate Evaluated by the RECIST Criteria

    The overall response is determined by combining the patient's status on target lesions, PSA, non-target lesions, and new disease as defined in the following table.

    Target Lesions CR CR PR SD PD Any Any Any

    PSA Response CR PR PR Non-PD Any Any PD Any

    Non-Target Lesions CR Non-CR/Non-PD Non-PD Non-PD Any PD Any Any

    New Lesions No No No No Yes or No Yes or No Yes or No Yes

    Overall Response CR PR PR SD PD PD PD PD

    Measured: Up to 52 weeks

  3. Time to Progression

    Analyzed with standard K-M methodology. Both point and 95% CI estimates of the median and other statistics (e.g., the 3-month rate, 6-month rate, etc.) will be computed from the censored distribution of TTP. These point and CI estimates will be reported for all patients combined, and separately for each treatment arm.

    Measured: The time from registration date until documented clinical disease progression, or until date of death, whichever occurs first, assessed up to 52 weeks

  4. Overall Survival

    Analyzed with standard K-M methodology. A 12 month survival rate will be calculated since median survival was not reached by the end of the study period.

    Measured: The time from registration date until death from any cause, assessed up to 52 weeks

Timeline

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

  1. First posted10 Sep 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionJul 2012
  4. Study completionNov 2013

Why it stopped: Closure was recommended by CTEP due to slow accrual.

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00527124
Sponsor's protocol ID
NCI-2009-00174
Other IDs
NCI-2009-00174, 2007-015, CDR0000564449, 2007-015, 7451, N01CM00038, U01CA062491, P30CA022453
Status last verified
Jul 2018
First submitted
7 Sep 2007
Last updated
9 Aug 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cediranib maleate, docetaxel and prednisone in people with Adenocarcinoma of the Prostate and Stage IV Prostate Cancer, run by National Cancer Institute (NCI) at 4 sites 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: stopped early, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Yes. Results are posted in the registry (first posted 11 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

6-month Progression-free Survival (PFS) Proportion (time frame: Followed for 52 weeks at 3 month intervals after coming off treatment, time period equal to the length of treatment + up to 12 months). 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 NCT00527124.

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 9 Aug 2018.

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