Prostate CancerPhase 2NCT00276549

Gemcitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer

A Phase 2 study testing docetaxel and gemcitabine hydrochloride in people with Prostate Cancer, run by Case Comprehensive Cancer Center 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 gemcitabine 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?: docetaxel and gemcitabine hydrochloride
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: Oct 2005to Mar 2008
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

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the prostate
Androgen-independent metastatic prostate cancer with evidence of clinical, radiographic, or biochemical progression in the setting of castrate levels of testosterone (< 50 mg/dL)
No androgen-independent prostate cancer with a rising prostate-specific antigen (PSA) without clinical or radiographic evidence of metastases
Clinical or radiographic evidence of metastatic disease with a rising PSA measured 2 times at ≥ 1 week interval allowed
Antiandrogen therapy must have been stopped at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide or nilutamide) prior to study entry with evidence of either a rising PSA (from baseline) measured twice at least 2 weeks apart or radiographic evidence of disease progression
Testicular androgen suppression (< 50 mg/dL) must be maintained with either luteinizing-hormone releasing-hormone (LHRH) therapy or bilateral orchiectomy
No clinical evidence of CNS metastases

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Bilirubin ≤ 1.5 mg/dL
AST and ALT ≤ 2 times normal
Creatinine < 2 mg/dL
No history of severe uncontrolled congestive heart failure (CHF), ventricular dysrhythmias, or severe cardiovascular disease (American Heart Association class III or IV)
Disease-free of prior malignancies for ≥ 5 years, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or low-grade, low-stage bladder cancer
No active infection or parenteral antibiotics within 7 days of study entry
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No radiation therapy within 4 weeks prior to study entry
No filgrastim (G-CSF) within 24 hours before or after study therapy
No prior systemic chemotherapy for metastatic disease
Neoadjuvant or adjuvant non-taxane chemotherapy more than 1 year prior to study entry allowed
No concurrent local radiotherapy for control of pain or life-threatening situations

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Phase II Trial of Gemcitabine And Docetaxel In Androgen-Independent Metastatic Prostate Cancer

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

Read the detailed description

OBJECTIVES:

Determine the objective response rate and toxicity in patients with androgen-independent metastatic prostate cancer treated with gemcitabine hydrochloride and docetaxel.

OUTLINE: This is an open-label study.

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 followed by docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for at least 5 years.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

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

What participants receive

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

docetaxelDrug
docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
gemcitabine hydrochlorideDrug
IV over 30 minutes on days 1 and 8 followed by docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Study groups in NCT00276549
Study group	Role	What they receive
Gemcitabine and Docetaxel i	Experimental	Not described Receives: Drug: docetaxel; Drug: gemcitabine hydrochloride

What is being measured

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

Objective PSA Response Rate (Number of Patients With a PSA Response)
Decline from a baseline value by ≥ 50% or normalization of PSA (< 0.03) confirmed by a second measurement at least 1 week or more weeks later. Patients must not demonstrate clinical or radiographic evidence of disease progression during this time period. The date of response will be defined as the first date at which the PSA declined from baseline by ≥ 50% or normalized.
Measured: every 4 weeks
Number of Patients With Measurable Soft Tissue Disease Will be Assessed Per Solid Tumor Response Criteria (RECIST).
Patients who have a response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by RECIST criteria. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of SD, patients who do not meet the criteria for response or progressive disease for at least 90 days will be categorized as stable disease.
Measured: at 4 weeks after treatment completion

Timeline

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

Oct 2005Mar 2008

First posted13 Jan 2006 (estimated)
Study startOct 2005
Primary completionMar 2008
Study completionMar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00276549
Sponsor's protocol ID: CCF7143
Other IDs: P30CA043703, CASE-CCF-7143
Status last verified: Jan 2013
First submitted: 12 Jan 2006
Last updated: 31 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Trial of Gemcitabine And Docetaxel In Androgen-Independent Metastatic Prostate Cancer
ClinicalTrials.gov ID: NCT00276549
Acronym / sponsor ID: CCF7143
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate, stage IV prostate cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Case Comprehensive Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Oct 2005
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 13 Jan 2006 (estimated)
Results: Posted 6 Jun 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

OBJECTIVES:

Determine the objective response rate and toxicity in patients with androgen-independent metastatic prostate cancer treated with gemcitabine hydrochloride and docetaxel.

OUTLINE: This is an open-label study.

After completion of study treatment, patients are followed periodically for at least 5 years.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Gemcitabine and Docetaxel i	Experimental	Drug: docetaxel, Drug: gemcitabine hydrochloride

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
docetaxeldocetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Drug	Gemcitabine and Docetaxel i
gemcitabine hydrochlorideIV over 30 minutes on days 1 and 8 followed by docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Drug	Gemcitabine and Docetaxel i

Primary outcome

Objective PSA Response Rate (Number of Patients With a PSA Response)
Time frame: every 4 weeks
Decline from a baseline value by ≥ 50% or normalization of PSA (< 0.03) confirmed by a second measurement at least 1 week or more weeks later. Patients must not demonstrate clinical or radiographic evidence of disease progression during this time period. The date of response will be defined as the first date at which the PSA declined from baseline by ≥ 50% or normalized.
Number of Patients With Measurable Soft Tissue Disease Will be Assessed Per Solid Tumor Response Criteria (RECIST).
Time frame: at 4 weeks after treatment completion
Patients who have a response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by RECIST criteria. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of SD, patients who do not meet the criteria for response or progressive disease for at least 90 days will be categorized as stable disease.

Results and safety

Results posted to the registry on 6 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gemcitabine (Gemzar) and Docetaxel (Taxotere)	35	35

Primary outcome: Objective PSA Response Rate (Number of Patients With a PSA Response)

Time frame: every 4 weeks. Number. Unit: participants

Measure	Gemcitabine (Gemzar) and Docetaxel (Taxotere) n = 35
Number of patients with a response ≥ 50%	17
Number of patients with no response	18

Population analysed: All patients that received treatment.

Primary outcome: Number of Patients With Measurable Soft Tissue Disease Will be Assessed Per Solid Tumor Response Criteria (RECIST).

Time frame: at 4 weeks after treatment completion. Number. Unit: participants

Measure	Gemcitabine (Gemzar) and Docetaxel (Taxotere) n = 22
Partial Response	3
Stable Disease	19

Population analysed: 25 patients had RECIST defined measurable disease at study entry. Confirmed response required 2 consecutive measurements at least 1 week later.Three patients did not have follow up measurements therefore were not evaluable.

Adverse events

Time frame: Patients were followed for adverse events while on treatment and on study over a two year time frame.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gemcitabine (Gemzar) and Docetaxel (Taxotere)	7 of 35 (20%)	35 of 35 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Enrolling by invitationObservational study
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STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Dreicer, MD, FACP study chair

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing docetaxel and gemcitabine hydrochloride in people with Prostate Cancer, run by Case Comprehensive Cancer Center 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 31 Jan 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?

Yes. Results are posted in the registry (first posted 6 Jun 2012). 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?

Objective PSA Response Rate (Number of Patients With a PSA Response) (time frame: every 4 weeks). The study lists 2 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 NCT00276549.

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 31 Jan 2013.