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Prostate CancerPhase 2NCT00258284

Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer

A Phase 2 study testing capecitabine and docetaxel in people with Prostate Cancer, run by Barbara Ann Karmanos Cancer Institute 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

RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
capecitabine and docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Aug 2003to Nov 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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • Metastatic disease
  • Androgen-independent disease
  • Progressive disease, as documented by ≥ 1 of the following criteria:
  • Rising prostate-specific antigen (PSA) despite androgen deprivation therapy and anti-androgen withdrawal
  • Demonstrates a rising PSA trend with 2 successive elevations ≥ 1 week apart
  • Measurable disease progression
  • Nonmeasurable disease progression, defined as the following:
  • PSA ≥ 5 ng/mL
  • New areas of bone metastases on bone scan
  • Serum testosterone ≤ 0.5 ng/mL (castrate level)
  • Concurrent luteinizing hormone-releasing hormone agonist therapy required for medically castrated patients

PATIENT CHARACTERISTICS:

Performance status

  • Zubrod 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/ mm^3
  • Hemoglobin ≥ 8.0 g/dL
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin normal
  • Transaminases meeting 1 of the following criteria:
  • AST and/or ALT ≤ 2.5 times upper limit of normal (ULN) if alkaline phosphatase (AP) normal
  • AP ≤ 4 times ULN if AST and/or ALT normal

Renal

  • Creatinine clearance ≥ 50 mL/min OR
  • Creatinine ≤ 2 mg/dL

Cardiovascular

  • No congestive heart failure
  • No second- or third-degree heart block
  • No myocardial infarction within the past 3 months

Other

  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • No other malignancy within the past 2 years except adequately treated skin cancer or other cancer in complete remission
  • No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • No peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • No prior chemotherapy for metastatic disease

Endocrine therapy

  • See Disease Characteristics
  • More than 4 weeks since prior flutamide
  • More than 6 weeks since prior bicalutamide or nilutamide

Radiotherapy

  • At least 4 weeks since prior radiotherapy

Other

  • At least 28 days since prior investigational drugs for prostate cancer
  • No other concurrent anti-cancer therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

Other trials in United States

About this study

Official title: Phase II Trial of Capecitabine (Xeloda) and Weekly Docetaxel (Taxotere) in Metastatic Androgen Independent Prostate Carcinoma

RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving capecitabine together with docetaxel works in treating patients with metastatic prostate cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the response rate in patients with androgen-independent metastatic adenocarcinoma of the prostate treated with capecitabine and docetaxel.

Secondary

  • Determine the toxicity of this regimen in these patients.
  • Determine the progression-free survival, time to treatment failure, and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR

After completion of study treatment, patients are followed periodically for survival.

PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.

Conditions
Prostate Cancer
Being tested
capecitabine, docetaxel
Keywords
recurrent prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • capecitabineDrug

    Also called Xeloda®

    Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR

  • docetaxelDrug

    Also called Taxotere®

    Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR

Study groups in NCT00258284
Study groupRoleWhat they receive
Docetaxel & CapecitabineExperimentalPatients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
Receives: Drug: capecitabine; Drug: docetaxel

What is being measured

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

  1. Response rate by RECIST criteria after every 2 courses

    Measured: at cycle 2 and every other cycle thereafter

Secondary outcomes (5)

  1. Toxicity at 30 days after last treatment

    Measured: Every week during treatment cycles

  2. Progression-free survival

    Measured: Every 2 cycles

  3. Time to treatment failure

    From date of registration to date of progressive disease, or date patient is taken off study for any other reason.

    Measured: Every 2 cycles

  4. Overall survival

    Measured: Every 2 cycles

  5. Effect of treatment on biological correlates (thymidine phosphorylase, dihydropyrimidine dehydrogenase, thymidylate synthase)

    Measured: Every week during treatment cycles

Timeline

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

  1. First posted24 Nov 2005 (estimated)
  2. Study startAug 2003
  3. Primary completionNov 2007
  4. Study completionNov 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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00258284
Sponsor's protocol ID
CDR0000445613
Other IDs
P30CA022453, WSU-D-2615, WSU-HIC-067903MP4F
Status last verified
Mar 2014
First submitted
22 Nov 2005
Last updated
6 Mar 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing capecitabine and docetaxel in people with Prostate Cancer, run by Barbara Ann Karmanos Cancer Institute 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?

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 6 Mar 2014. 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?

Response rate by RECIST criteria after every 2 courses (time frame: at cycle 2 and every other cycle thereafter). 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 NCT00258284.

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 6 Mar 2014.

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