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Prostate CancerPhase 2NCT00216099

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

A Phase 2 study testing Pemetrexed, Folic Acid and Vitamin B12 in people with Prostate Cancer, run by Christopher Sweeney, MBBS at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Pemetrexed, Folic Acid and Vitamin B12
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
15 sitesUnited States
Study dates
Feb 2005to Mar 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Consultants in Medical Oncology & Hematology

    Drexel Hill, Pennsylvania, 19026

  • Elkhart Clinic

    Elkhart, Indiana, 46515

  • Fort Wayne Oncology & Hematology, Inc

    Fort Wayne, Indiana, 46815

  • Medical & Surgical Specialists, LLC

    Galesburg, Illinois, 61401

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202

  • Quality Cancer Center (MCGOP)

    Indianapolis, Indiana, 46202

  • Community Regional Cancer Center

    Indianapolis, Indiana, 46256

  • Center for Hematology/Oncology of S. Michigan

    Jackson, Michigan, 49201

  • Arnett Cancer Care

    Lafayette, Indiana, 47904

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

    Mount Holly, New Jersey, 08060

  • Medical Consultants, P.C.

    Muncie, Indiana, 47303

  • Methodist Cancer Center

    Omaha, Nebraska, 68114

  • Pennsylvania Oncology-Hematology Associates

    Philadelphia, Pennsylvania, 19106

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46601

  • AP&S Clinic

    Terre Haute, Indiana, 47804

Other trials in United States

About this study

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

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.

Read the detailed description

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

Hematopoietic:

  • Absolute Neutrophil Count (ANC) > 1500/mm3
  • Platelet count > 100,000/mm3
  • Hemoglobin > 9 g/dL

Hepatic:

  • Bilirubin < 1.5 X upper limit of normal (unless due to Gilbert's disease)
  • Alkaline phosphatase and Alanine Transanimase (ALT) (SGPT) < 3 X upper limit of normal (ULN); may be < 5 X ULN for patients with liver metastases. Alkaline phosphatase may be any value for patients with bone metastases.

Renal:

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

Cardiovascular:

  • No congestive heart failure requiring therapy or New York Heart Association (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 therapy
  • Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation, paroxysmal supraventricular tachycardia, or controlled hypertension are eligible

Pulmonary:

  • Not specified
Conditions
Prostate Cancer
Being tested
Pemetrexed, Folic Acid, Vitamin B12
Keywords
Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PemetrexedDrug

    Also called Alimta

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

  • Folic AcidDietary 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.

  • Vitamin B12Dietary 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.

Study groups in NCT00216099
Study groupRoleWhat they receive
Investigational TreatmentExperimental* 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
Receives: Drug: Pemetrexed; Dietary Supplement: Folic Acid; Dietary Supplement: Vitamin B12

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (7)

  1. Overall Survival

    Measured: From study enrollment until death (for life)

  2. OBJECTIVE Overall Response Rate

    Response Evaluation Criteria in Solid Tumors (RECIST). Objective overall response rate is defined as Complete Response (CR) + Partial Response (PR)

    Per RECIST:

    CR= Disappearance of all target and non-target lesions and normalization of tumor marker level PR= Disappearance of all target lesions and persistence of non-target lesion(s) or maintenance of tumor marker level above normal limits OR at least a 30% decrease in the sum of the longest diameter, taking as reference the baseline sum longest diameter and disappearance of all non-target lesions or persistence of non-target lesion(s) or maintenance of tumor marker level above normal limits

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

  3. Rate of Clinical Benefit

    A clinical benefit is defined as an improvement for at least 3 consecutive weeks in at least one of the following parameters without any sustained worsening in any other:

    > 50% reduction in analgesic consumption or > 50% reduction in pain intensity or > 20 point gain in performance status.

    Measured: Any time among evaluable subjects (for life)

  4. Safety and Tolerability

    Safety and Tolerability was evaluated by reporting the percentage of patient who experienced grade 3 or 4 toxicities using Common Terminology Criteria for Adverse Events CTCAE v3.0 criteria. CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.

    Measured: 18 months

  5. RFC1 G80A Genotype

    Samples for RFC1 G80A pharmacogenetic analysis were collected at screening

    Measured: Screening

  6. Time to Progression

    Progression per Response Evaluation Criteria in Solid Tumors (RECIST) or Prostate-Specific Antigen (PSA) Progression RECIST PD=at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions PSA progression=increase in PSA to >50% above lowest level recorded on study. Two consecutive increases required at least 4 weeks apart, but time to progression will be determined at time of first PSA showing increase > 50% above baseline *Note, upper confidence interval was not reached*

    Measured: Study enrollment until progression per RECIST or PSA (for life)

  7. Time to Prostate-Specific Antigen (PSA)/Serological Progression

    Serological Progression (sPD) - increase in PSA to >50% above lowest level recorded on study. Two consecutive increases required at least 4 weeks apart, but time to progression will be determined at time of first PSA showing increase > 50% above baseline

    Measured: From study enrollment to progression per PSA criteria (for life)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startFeb 2005
  3. Primary completionMar 2009
  4. Study completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00216099
Sponsor's protocol ID
HOG GU03-67
Status last verified
Jun 2016
First submitted
12 Sep 2005
Last updated
29 Jul 2016
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 19605506

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pemetrexed, Folic Acid and Vitamin B12 in people with Prostate Cancer, run by Christopher Sweeney, MBBS at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Overall PSA Response (time frame: Start of treatment until disease progression/recurrence (for life)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00216099, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.

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