Pemetrexed as Second-Line Therapy in Treating Patients With Hormone Refractory Prostate Cancer

NCT00216099 | Completed Phase 2 Results DMC

• 1 other identifier: HOG GU03-67
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 15

Brief Summary

Docetaxel-based therapy has been shown to prolong survival as first-line therapy for patients with hormone refractory prostate cancer (HRPC), and has become the standard of care. The beneficial effects of any therapy in HRPC may be diverse and include reduction in tumor bulk (when measurable), reduction in prostate-specific antigen PSA, reduction in symptoms (particularly pain), or stabilization of disease. Clear reductions in tumor bulk or PSA may provide objective evidence of a treatment effect, and stabilization of disease may be just as clinically meaningful in patients who are actively progressing prior to starting therapy. Pemetrexed has shown a broad array of activity in many diseases that until now were thought to be non-responsive to chemotherapy in the second-line setting. This trial is designed to further assess the efficacy, safety, tolerability, and pharmacogenetics of pemetrexed as a single agent in subjects with HRPC whose disease has progressed following one prior taxane-based chemotherapy regimen for HRPC.

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Best Overall PSA Response

  Best overall Prostate-Specific Antigen (PSA) response PSA response is defined by a greater than or equal to 50% decline in PSA confirmed by a second PSA value at least 4 weeks after the first PSA response timepoint PSA Stable Disease is defined as less than a 50% decline in PSA and less than a 50% increase in PSA from baseline PSA progression is defined as greater than or equal to a 50% increase in PSA compared to baseline

  Start of treatment until disease progression/recurrence (for life)

Secondary Outcomes (7)

• Overall Survival

  From study enrollment until death (for life)

• OBJECTIVE Overall Response Rate

  Start of treatment until disease progression/recurrence (for life)

• Rate of Clinical Benefit

  Any time among evaluable subjects (for life)

• Safety and Tolerability

  18 months

• RFC1 G80A Genotype

  Screening

Study Arms (1)

Investigational Treatment

EXPERIMENTAL

* Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle * Oral Folic Acid, once per day for 7 days preceding pemetrexed dose, continued daily, and for 21 days after the last dose of pemetrexed. * Vitamin B12, 1000ug intramuscular injection 7 days preceding pemetrexed dose, and every three cycles thereafter on the same day of pemetrexed administration

Drug: Pemetrexed; Dietary Supplement: Folic Acid; Dietary Supplement: Vitamin B12

Interventions

Pemetrexed DRUG

Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle

Also known as: Alimta

Investigational Treatment

Folic Acid DIETARY_SUPPLEMENT

All participants received oral Folic Acid 350-100ug once per day for 7 days preceding the first pemetrexed dose and continuing throughout the study and and for 21 days after the last dose of pemetrexed.

Investigational Treatment

Vitamin B12 DIETARY_SUPPLEMENT

All patients received vitamin B12 1000ug intramuscular injection the week preceding the first pemetrexed dose and received additional 1000ug intramuscular injections every three cycles thereafter on the same day of pemetrexed administration.

Investigational Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Intravenous radio-isotopes therapy must be completed at least 6 weeks prior to registration
• No brain metastasis that are untreated and/or not controlled and/or still requiring corticosteroids
• 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

Sponsors & Collaborators

• Christopher Sweeney, MBBS: lead
• Eli Lilly and Company: collaborator
• Walther Cancer Institute: collaborator

Study Sites (15)

Medical & Surgical Specialists, LLC

Galesburg, Illinois, 61401, United States

Location

Elkhart Clinic

Elkhart, Indiana, 46515, United States

Location

Fort Wayne Oncology & Hematology, Inc

Fort Wayne, Indiana, 46815, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Quality Cancer Center (MCGOP)

Indianapolis, Indiana, 46202, United States

Location

Community Regional Cancer Center

Indianapolis, Indiana, 46256, United States

Location

Arnett Cancer Care

Lafayette, Indiana, 47904, United States

Location

Medical Consultants, P.C.

Muncie, Indiana, 47303, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

AP&S Clinic

Terre Haute, Indiana, 47804, United States

Location

Center for Hematology/Oncology of S. Michigan

Jackson, Michigan, 49201, United States

Location

Methodist Cancer Center

Omaha, Nebraska, 68114, United States

Location

Hematology Oncology Associates S.J., P.A.

Mount Holly, New Jersey, 08060, United States

Location

Consultants in Medical Oncology & Hematology

Drexel Hill, Pennsylvania, 19026, United States

Location

Pennsylvania Oncology-Hematology Associates

Philadelphia, Pennsylvania, 19106, United States

Location

Related Publications (1)

• Hahn NM, Zon RT, Yu M, Ademuyiwa FO, Jones T, Dugan W, Whalen C, Shanmugam R, Skaar T, Sweeney CJ. A phase II study of pemetrexed as second-line chemotherapy for the treatment of metastatic castrate-resistant prostate cancer (CRPC); Hoosier Oncology Group GU03-67. Ann Oncol. 2009 Dec;20(12):1971-6. doi: 10.1093/annonc/mdp244. Epub 2009 Jul 15.

  PMID: 19605506 RESULT

Related Links

• Hoosier Oncology Group Home Page

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Pemetrexed; Folic Acid; Vitamin B 12

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Pterins; Pteridines; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Jeff Smith
• Organization: Hoosier Cancer Research Network

jsmith@hoosiercancer.org

317-921-2050

Study Officials

• Christopher Sweeney, M.B.B.S.

  Hoosier Oncology Group, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 22, 2005
• Study Start: February 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: July 29, 2016
• Results First Posted: July 29, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)