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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Male
Prostatic Neoplasms

Thank you

Trial Information

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


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.

Inclusion Criteria


Inclusion criteria

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]:

1. Progressive measurable disease (changes in the size of lymph nodes or
parenchymal masses on physical examination or x-ray).

2. Progressive bone metastasis [presence of new lesion(s) on a bone scan].

3. 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

M34101-033

NCT ID:

NCT00064610

Start Date:

December 2002

Completion Date:

Related Keywords:

  • Prostatic Neoplasms
  • Advanced androgen-independent prostate cancer
  • Neoplasms
  • Prostatic Neoplasms

Name

Location

Cedars Sinai Medical CenterLos Angeles, California  90048-1804
Cleveland Clinic FoundationCleveland, Ohio  44195
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
Columbia-Presbyterian HospitalNew York, New York  10032