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A Phase II Study of Pemetrexed (Alimta) as Second-Line Therapy for Hormone Refractory Prostate Cancer: Hoosier Oncology Group GU03-67

Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

A Phase II Study of Pemetrexed (Alimta) as Second-Line Therapy for Hormone Refractory Prostate Cancer: Hoosier Oncology Group GU03-67

OUTLINE: This is a multi-center study.

- Pemetrexed 500mg/m2 will be administered intravenously over approximately 10-minutes on
Day 1 of a 21-day cycle.

- Folic Acid (350-1000 mcg. PO daily) will be taken by patients to reduce toxicity. At
least 5 daily doses of folic acid must be taken during the 7-day period preceding the
first dose of pemetrexed, and dosing should continue during the full course of therapy
and for 21 days after the last dose of pemetrexed.

- Vitamin B12 (1000 µg) will be administered as an intramuscular injection during the
week preceding the first dose of pemetrexed and every 3 cycles thereafter. Subsequent
vitamin B12 injections may be given the same day as pemetrexed.

Performance Status: Karnofsky Performance Status 70-100

Life expectancy > 12 weeks


- ANC > 1500/mm3

- Platelet count > 100,000/mm3

- Hemoglobin > 9 g/dL


- Bilirubin < 1.5 X upper limit of normal (unless due to Gilbert's disease)

- Alkaline phosphatase and ALT (SGPT) < 3 X upper limit of normal; may be < 5 X ULN for
patients with liver metastases. Alkaline phosphatase may be any value for patients
with bone metastases.


- Calculated creatinine clearance >45 mL/min based on the standard Cockroft and Gault


- No congestive heart failure requiring therapy or NYHA class II or greater or active
angina or known myocardial infarction within 12 months prior to study

- No unstable angina, uncontrolled congestive heart failure, or unstable symptomatic
arrhythmia requiring medication within 6 months prior to being registered for protocol

- Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation, paroxysmal
supraventricular tachycardia, or controlled hypertension are eligible


- Not specified

Inclusion Criteria:

- Histologically documented adenocarcinoma of the prostate

- Clinically refractory or resistant to hormone therapy as assessed by progression
following at least one hormonal therapy (orchiectomy or luteinizing hormone-releasing
hormone (LHRH) agonist)

- One prior taxane based chemotherapy regimen for HRPC

- Documented progression of disease after one taxane based prior chemotherapy regimen
for HRPC. Progression is defined as at least one of the following:

- An increase in PSA > 50% over nadir value on prior Taxane-based therapy

- Progression of measurable disease as defined by RECIST

- Progression of bone disease as defined by the appearance of one or more new bone
lesions or worsening symptoms

- Orchiectomy or testosterone levels < 50 ng/dL maintained by LHRH agonist

- Prior chemotherapy, or other experimental anticancer agents must be completed > 4
weeks prior to being registered for protocol therapy

- Palliative radiotherapy must be completed at least 14 days prior to registration.

Exclusion Criteria:

- Intravenous radio-isotopes therapy must be completed at least 6 weeks prior to

- No brain metastasis that are untreated and/or not controlled and/or still requiring

- No history of other malignancies within 5 years prior to being registered for
protocol therapy, except for adequately treated basal or squamous cell skin cancer

- No history of uncontrolled psychiatric illness or serious systemic disease, including
active infection, uncontrolled hypertension

- No surgery or significant traumatic injury within 21 days prior to being registered
for protocol therapy

- Patients must be willing to interrupt aspirin or other non-steroidal
anti-inflammatory agents for a 5-day period (8 day period for long acting agents such
as piroxicam)

- Patients must be willing to take folic acid or vitamin B12 supplementation

Type of Study:


Study Design:

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

Outcome Measure:

· To determine the rates of best overall PSA response (≥ 50% decline in PSA) at any time during the study with single agent pemetrexed in subjects with HRPC whose disease has progressed following one prior taxane based chemotherapy regimen for HRPC·

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Christopher Sweeney, M.B.B.S.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group, LLC


United States: Institutional Review Board

Study ID:

HOG GU03-67



Start Date:

February 2005

Completion Date:

March 2009

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Prostatic Neoplasms



Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Methodist Cancer CenterOmaha, Nebraska  68114
Arnett Cancer CareLafayette, Indiana  47904
Consultants in Medical Oncology & HematologyDrexel Hill, Pennsylvania  19026
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Medical & Surgical Specialists, LLCGalesburg, Illinois  61401
Elkhart ClinicElkhart, Indiana  46515
Community Regional Cancer CenterIndianapolis, Indiana  46256
Quality Cancer Center (MCGOP)Indianapolis, Indiana  46202
Medical Consultants, P.C.Muncie, Indiana  47303
AP&S ClinicTerre Haute, Indiana  47804
Fort Wayne Oncology & Hematology, IncFort Wayne, Indiana  46815
Center for Hematology/Oncology of S. MichiganJackson, Michigan  49201
Hematology Oncology Associates S.J., P.A.Mt. Holly, New Jersey  08060
Pennsylvania Oncology-Hematology AssociatesPhiladelphia, Pennsylvania  19106