GM-CSF for Maintenance of Prostate Cancer for Patients Responding to Taxotere

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00274287

Enrollment

Registered

2006-01-10

Start date

2006-01-31

Completion date

2010-12-31

Last updated

2019-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief summary

This trial is designed to investigate the efficacy and safety of GM-CSF used as a maintenance program in patients with androgen-independent prostate cancer (AIPC) who have achieved a maximal response on a taxotere or other chemotherapy schedule.

Detailed description

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.

Interventions

DRUGGM CSF

250 ug/m2 daily for 2 weeks followed by 2 weeks of rest

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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 elevation. 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 ng/ml * 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 progression * 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

Design outcomes

Primary

Measure	Time frame	Description
Time to Disease Progression (TTP)	up to 21 months	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). PD was defined as more than 20% in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies. Median TTP from GM-CSF administration and Median TTP from start of chemotherapy is being reported

Secondary

Measure	Time frame	Description
Response Rate (PSA)	up to 21 months	Biochemical PR (Partial Response) was defined as a PSA that decreases by 50% and maintains by at least 3 weeks by confirmatory measurement. Biochemical SD (stable disease) was defined as a PSA that was increased by less than 25% or decreased by less than 50% Biochemical PD (progressive disease) was defined as an increase of at least 25% confirmed 3 weeks after.
Response Rate (Radiographic)	up to 21 months	PR was defined as more than 30% decrease in the sum of the longest diameter of measurable lesions compared to baseline. SD was defined when lesions did not meet criteria for PR or PD. PD was defined as more than 20% increase in the sum of the longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions at imaging studies. The appearance of 2 or more new boney lesions on bone scan development of cord compression, and pathologic fractures constituted PD.
Median Overall Survival (OS)	up to 44 months	—
Median Number of GM-CSF Cycles	up to 12 months	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
GM-CSF (Leukine) Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.	15
Total	15

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	subject non-compliance	1
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	GM-CSF (Leukine)
Age, Continuous	78 years
Gleason Score >=7	14 Participants
Median alkphos	97 U/L
Median number of prior therapies	2 therapies
median PSA	51.7 ng/dl
Median time from diagnosis to GM-CSF	71 months
Prior initial therapy ADT (androgen deprivation therapy)	7 Participants
Prior initial therapy RP (radical prostatectomy)	3 Participants
Prior initial therapy RT (radiation therapy)	5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	14 Participants
Region of Enrollment United States	15 participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	15 Participants
Site of Metastases bone	7 Participants
Site of Metastases visceral disease	1 Participants
Site of Metastases viseral and bone	7 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	7 / 15
serious Total, serious adverse events	7 / 15

Outcome results

Primary

Time to Disease Progression (TTP)

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). PD was defined as more than 20% in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies. Median TTP from GM-CSF administration and Median TTP from start of chemotherapy is being reported

Time frame: up to 21 months