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A Phase II Pilot Study Investigating the Efficacy and Activity of Single Agent GM-CSF (Leukine) Maintenance Approach in Androgen-independent Prostate Cancer (AIPC) Patients Responding to Taxotere Chemotherapy

Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

A Phase II Pilot Study Investigating the Efficacy and Activity of Single Agent GM-CSF (Leukine) Maintenance Approach in Androgen-independent Prostate Cancer (AIPC) Patients Responding to Taxotere Chemotherapy

Patients will be treated on this single arm, open label trial until primary end point is
met, patient's withdrawal, or investigator's discretion. After achieving a maximal response
on taxotere or other chemo schedule they were eligible to enroll in this trial and begin
treatment with maintenance GMCSF for 2 weeks followed by 2 weeks of rest. Once progression
was documented the patients were taken off study.

Inclusion Criteria:

1. Men >18 years of age. No upper age limit

2. Written informed consent approved by institutional review board should be explained
to and signed by patient

3. Documentation of histologically confirmed adenocarcinoma of the prostate. Gleason
score of any sum is allowed on this study.

4. Metastatic disease as evidenced by visceral involvement, bone disease, or PSA

5. Patients should meet the criteria of androgen independent prostate cancer (AIPC).
Patients would fulfill these criteria if they continue to progress despite complete
androgen blockade (surgical or medical castration with anti-androgen) and despite an
anti-androgen withdrawal trial. Failing anti-androgen withdrawal is defined as no
decline by 25% or more 3-weeks after stopping anti-androgens.

Progression on hormonal therapy is defined as ANY of the following:

- PSA: 2 consecutive rising PSA values, at least 14-days apart, each being > 5

- For patients with visceral measurable disease, progression is defined as an
increase by 50% or more in the size of measurable areas, or any development of
new lesions.

- For patients with bone-only disease, progression is defined as the appearance of
2 or more new areas of abnormal uptake on a bone scan, when compared to prior
imaging studies. Changes in the uptake of already existing lesions will NOT be
used to define progressive disease.

- For patients with bone AND visceral disease, fulfilling any of the criteria in
5.2 or 5.3 is sufficient to define progression.

6. Castration levels of testosterone (< 50 ng/dl) achieved via medical or surgical
castration. Patients should continue on LHRH agonists throughout if this is the
method used to achieve castration.

7. Life expectancy of at least 6 months

8. Adequate hematologic, renal, and liver function as evidenced by the following:

- WBC > 2000,

- ANC > 1000,

- Platelet count > 100,000,

- HgB > 9.0 g/dl, Creatinine < 2,

- Total bilirubin < 2x upper limit of normal,

- AST and ALT < 3 x upper limit of normal

9. ECOG performance status of 0 or 1.

10. The use of intravenous polyphosphates for bone metastases is allowed.

11. upon completion of the taxotere portion of study, patient can be enrolled & receive
GM-CSF if ANY of the following criteria is met:

- Patients received total of 8 cycles of taxotere & have no signs of disease

- Patients achieved their maximal response despite receiving < than 8 cycles of
taxotere. Maximum response is defined as a drop in measures of PSA by 10% or
less on 2 consecutive measurements.

- Patients who have completed their chemotherapy < than 12 weeks prior to opening
this trial & still have stable disease without progression (by PSA and
radiographically) will be eligible to receive maintenance GM-CSF

Exclusion Criteria:

1. presence of brain metastases

2. Known HIV+ status

3. ECOG performance status of 2 or higher

4. Use of investigational agents within 4 weeks of starting

5. Patients with prior exposure to more than one chemotherapy program Patients who have
received one chemotherapy schedule can be enrolled on study and receive GM-CSF (the
maintenance arm) if their last chemotherapy was taxotere, given within the past 12
weeks, and they have demonstrated NO evidence of progression radiographically and
biochemically. Prior exposure to steroids is NOT an exclusion criteria.

6. Patients with other active malignancies (excluding non-melanoma skin cancers)are
excluded. Prior malignancies are not exclusion criteria as long as last treatment for
such malignancies was over 5 years prior to enrollment.

7. Treatment with investigational products are NOT an exclusion criteria, if therapy was
last received over 4 weeks prior to enrollment.

8. Any medical intervention or other condition which, in the opinion of the principle
investigator, could compromise adherence with study requirements.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Disease Progression (TTP)

Outcome Description:

The primary end point of this study is to evaluate time to disease progression (TTP). TTP is defined as the time from starting taxotere until there is evidence of progressive disease (PD) as defined below (radiographically and/or biochemically.

Outcome Time Frame:

time to disease progression (up to 6 months)

Safety Issue:


Principal Investigator

Chadi Nabhan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oncology Specialists, SC


United States: Institutional Review Board

Study ID:




Start Date:

January 2006

Completion Date:

December 2010

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



Oncology Specialists, SC Park Ridge, Illinois  60068