Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Androgens

Sargramostim

Molgramostim

Immunologic Factors

Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GM-CSF as outlined in the protocol

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

GM CSF

Chadi Nabhan, MD

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.

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.

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

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

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.

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.

Genzyme, a Sanofi Company

Oncology Specialists, S.C.

Principal Investigator

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.

GM-CSF (Leukine)

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

the Gleason score is used to help evaluate the prognosis of men with prostate cancer. A Gleason score is given to prostate cancer based upon its microscopic appearance. Cancers with a higher Gleason are more aggressive and have a worse prognosis. Scores range from 2-10.

Gleason Score >=7

granulocyte macrophage colony-stimulating factor

Median time from diagnosis to GM-CSF

Median number of prior therapies

median PSA

Median alkphos

RT (radiation therapy)

ADT (androgen deprivation therapy)

RP (radical prostatectomy)

Prior initial therapy

bone

visceral disease

viseral and bone

Site of Metastases

TTP from GM-CSF

TTP from chemotherapy

Taxotere is given at 75 mg/m2 on day 1 intravenously over 60 minutes with appropriate and standard pre-medications. Patients are eligible to receive growth factor support with G-CSF or Neulasta on day 2 at the investigator's discretion.

Spots Global Cancer Trial Database for GM-CSF for Maintenance of Prostate Cancer for Patients Responding to Taxotere

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial