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Prostatic NeoplasmsPhase 1/2NCT00064610

Phase I/II Dose Escalation Study of VELCADE® and Docetaxel in Patients With Advanced Androgen-Independent Prostate Cancer

A Phase 1/2 study testing VELCADE TM (bortezomib) for Injection in people with Prostatic Neoplasms, run by Millennium Pharmaceuticals, Inc. at 4 sites 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

The purpose of this study is to evaluate how safe PS-341(VELCADE) is when given with Docetaxel (Taxotere) to patients with androgen-independent prostate cancer, and also to see what effects (good and bad) it has on you and on your cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
VELCADE TM (bortezomib) for Injection
Type of treatment
Injection or infusion
How many people
102 participants
Where
4 sitesUnited States
Study dates
Dec 2002to Dec 2004
Phase
Phase 1/2
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

Who may be able to join

  • Each patient must meet all of the following inclusion criteria to be enrolled in the study:
  • Patient has histologically-confirmed advanced and/or metastatic androgen-independent prostate cancer requiring anti-neoplastic treatment.
  • Previous or concurrent hormone therapy with a luteinizing hormone-releasing hormone analog (e.g., leuprolide) does not preclude enrollment in the study.
  • Patient has progressive measurable or evaluable disease, defined as meeting at least one of the following three criteria [1]:
  • Progressive measurable disease (changes in the size of lymph nodes or parenchymal masses on physical examination or x-ray).
  • Progressive bone metastasis [presence of new lesion(s) on a bone scan].
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  • Progressive PSA, as evidenced by two separate measurements taken at least one week apart and confirmed by a third, and if necessary, a fourth measurement.
  • If the third measurement is not greater than the second measurement, then a fourth measurement must be taken; the fourth measurement must be greater than the second measurement for the patient to be eligible for enrollment in the study.
  • The confirmatory PSA measurement (i.e., the third or, if applicable, fourth PSA measurement) must be greater than or equal to 5 ng/mL.
  • Patient is 18 years of age or older.
  • Patient has a Karnofsky performance status of 60% or greater.
  • Patient has a life expectancy of three months or longer.
  • Patient has all of the following pretreatment laboratory data within 14 days before the first study drug dose:
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mm3.
  • Platelets greater than or equal to100,000/mm3.
  • Hemoglobin >8.0 g/dL.
  • Serum creatinine less than or equal to 2.5 mg/dL.
  • Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
  • Patient agrees to use an acceptable barrier method for contraception from Screening through 90 days after the last study drug dose. [It is recommended that female partners of male patients enrolled in this study also use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence).]
  • Exclusion criteria Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
  • Patient has received chemotherapy within four weeks, nitrosoureas within six weeks, or antibody therapy within eight weeks of enrollment.
  • Patient has received radiation therapy within four weeks of enrollment.
  • Patient has not recovered from all toxic effects of previous chemotherapy or radiation or antibody therapy.
  • Patient received treatment with flutamide within four weeks of enrollment or nilutamide or bicalutamide within six weeks of enrollment.
  • Patient has had any major surgery within four weeks of enrollment.
  • Patient has a history of allergic reactions to diuretics or anti-emetics suggested to be administered in conjunction with study drug
  • Patient has a history of severe hypersensitivity reaction to docetaxel or other agents formulated with polysorbate 80.
  • Patient had a myocardial infarction within six months of enrollment or has uncontrolled angina, severe uncontrolled ventricular arrhythmias, symptomatic congestive heart failure, unstable angina pectoris, or electrocardiographic evidence of acute ischemia
  • Patient has uncontrolled brain metastases or central nervous system disease.
  • Patient has Grade 2 or higher peripheral neuropathy
  • Patient has any of the following pretreatment laboratory data within 14 days before the first study drug dose:
  • Total bilirubin > than the upper limit of normal (ULN).
  • Alanine transaminase (ALT) and/or aspartate transaminase (AST) >1.5 x the ULN concurrent with alkaline phosphatase >2.5 x the ULN.
  • Alkaline phosphatase >5 x the ULN, unless shown by fractionation to be bone-derived and AST, ALT, bilirubin, gamma glutamyl transferase (GGT), and 5'nucleotidase are <1.5 x the ULN and bilirubin is within normal range.
  • Serum testosterone 50 ng/mL or higher.
  • Patient is HIV-infected.
  • Patient is hepatitis B surface antigen positive or has previously documented hepatitis C infection.
  • Patient has an uncontrolled intercurrent illness (e.g., active infection).
  • Patient has another serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.

Who cannot join

None listed.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Columbia-Presbyterian Hospital

    New York, New York, 10032

Other trials in United States

About this study

Official title: A Phase I/II, Open Label, Dose Escalation Study to Determine the Tolerance and Preliminary Activity of PS-341 Plus Docetaxel in Patients With Advanced Androgen-Independent Prostate Cancer Requiring Chemotherapy

The purpose of this study is to evaluate how safe PS-341(VELCADE) is when given with Docetaxel (Taxotere) to patients with androgen-independent prostate cancer, and also to see what effects (good and bad) it has on you and on your cancer.

Read the detailed description

This is a dose escalation study, which means that the first group of patients will receive a low dose of PS-341 (VELCADE) and Docetaxel (Taxotere). If the low dose of VELCADE and Taxotere appears to be safe, then the next group of patients will receive a higher dose of VELCADE and Taxotere.

Being tested
VELCADE TM (bortezomib) for Injection
Keywords
Advanced androgen-independent 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.

  • VELCADE TM (bortezomib) for InjectionDrug

Timeline

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

  1. First posted11 Jul 2003 (estimated)
  2. Study startDec 2002
  3. Primary completionDec 2004

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
102 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00064610
Sponsor's protocol ID
M34101-033
Status last verified
Feb 2008
First submitted
10 Jul 2003
Last updated
11 Feb 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VELCADE TM (bortezomib) for Injection in people with Prostatic Neoplasms, run by Millennium Pharmaceuticals, Inc. 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 39 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 11 Feb 2008. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00064610.

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 11 Feb 2008.

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