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Hormone-resistant Prostate CancerPhase 2NCT01338792

Oxaliplatin and Pemetrexed Disodium in Treating Patients With Refractory Hormone-Resistant Prostate Cancer

A Phase 2 study testing oxaliplatin, pemetrexed disodium and questionnaire administration in people with Hormone-resistant Prostate Cancer and Recurrent Prostate Cancer, run by University of Southern California at 1 site 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

This phase II trial studies how well giving oxaliplatin and pemetrexed disodium together works in treating patients with refractory hormone-resistant prostate cancer. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
oxaliplatin, pemetrexed disodium and questionnaire administration
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteUnited States
Study dates
Jun 2006to Dec 2012
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 confirmed prostate cancer
  • Measurable disease on computed tomography (CT) or evaluable disease on bone scan with an elevated PSA
  • For patients who did not initially present with metastatic disease, definitive treatment with either radical prostatectomy or external beam radiation is permitted
  • Documented progression on (a) two prior hormone treatments AND (b) one or two chemotherapy regimens
  • Documented progression on two prior hormone therapies is defined as orchiectomy followed by anti-adrenal medication upon progression OR gonadotropin-releasing hormone (GnRH) analog +/- androgen receptor blocker with addition or subtraction upon progression; castrate level of testosterone must be documented at study entry
  • Documented progression on taxane-based chemotherapy; in addition, patients may have failed a second prior chemotherapy regimen
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  • Palliative radiation therapy for metastatic disease is allowed only if less than 25% of total body bone marrow was irradiated; 28 days must have elapsed since completion of radiation therapy (RT) with bone marrow recovery; soft tissue disease irradiated in the prior 2 months may not be designated as measurable disease
  • ECOG performance score of 0-2
  • Absolute neutrophil count (ANC) >= 1500/uL
  • Platelet count >= 100,000/uL
  • Creatinine clearance >= 45 mL/min
  • Serum total bilirubin =<1.5 mg/dL
  • Alkaline phosphatase =< 3x the upper limit of normal (ULN) for the reference lab (=< 5x the ULN for patients with known hepatic metastases) and no upper limit for patients with known bone metastases
  • Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase (SGPT) =< 3x the ULN for the reference lab (=< 5x the ULN for patients with known hepatic metastases)
  • Patients must be recovered from both acute and late effects of any prior surgery, radiotherapy or other antineoplastic therapy
  • Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial
  • Men of childbearing potential must consent to use barrier contraception while on treatment and for 90 days thereafter
  • Patients with pleural or peritoneal effusions are eligible
  • Willingness and ability to take vitamin supplementation and steroid premedication as specified in protocol
  • Patients with superficial bladder cancer or skin cancer who have second malignancy within 5 years which was removed with curative intent

Who cannot join

  • Active infection or with a fever >= 38.5 degrees Celsius (C) within 3 days of the first scheduled protocol treatment
  • Patients with brain metastases
  • Prior malignancy within the past 5 years, except for curatively treated basal cell or squamous cell carcinoma of the skin or superficial bladder cancer
  • Known hypersensitivity to any of the components of oxaliplatin or pemetrexed
  • Received radiotherapy to more than 25% of their bone marrow, or patients who received any radiotherapy within 4 weeks of entry
  • Received treatment with strontium
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  • Receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment
  • Life expectancy < 6 months
  • Peripheral neuropathy >= Grade 2
  • Any other medical condition, including mental illness or substance abuse
  • History of allogeneic transplant
  • Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated, or both)
  • Inability to stop nonsteroidal anti-inflammatory drugs (NSAIDS) for a period of 2 days before, the day of, and 2 days following administration of Alimta; 5 days before, the day of, and 2 days following administration of Alimta for long-acting NSAIDS

Trial locations and contacts

1 site in 1 country.

United States1 site

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: A Phase II Trial of Oxaliplatin and Pemetrexed in Hormone Refractory Prostate Cancer

This phase II trial studies how well giving oxaliplatin and pemetrexed disodium together works in treating patients with refractory hormone-resistant prostate cancer. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving oxaliplatin together with pemetrexed disodium may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES: I. To determine the response rate by Response Evaluation Criteria In Solid Tumors (RECIST) criteria, prostate-specific antigen (PSA) response by the PSA Working Group criteria, and overall clinical benefit defined by summation of RECIST complete responses (CR) plus RECIST partial responses (PR) plus PSA PRs. SECONDARY OBJECTIVES: I. To determine time to progression in patients with hormone-refractory prostate cancer (HRPC) receiving oxaliplatin and pemetrexed. II. To describe the safety profile of this treatment. III. Pain response will be evaluated in an exploratory manner. IV. Undertake a pilot analysis of excision repair cross-complementing 1 (ERCC1) expression levels and polymorphisms, looking at their ability to predict response to platinum therapy. OUTLINE: Patients receive oxaliplatin intravenously (IV) over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months.

Being tested
oxaliplatin, pemetrexed disodium, questionnaire administration, laboratory biomarker analysis, reverse transcriptase-polymerase chain reaction
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • oxaliplatinDrug

    Also called 1-OHP, Dacotin, Dacplat, Eloxatin

    Given IV

  • pemetrexed disodiumDrug

    Also called ALIMTA, LY231514, MTA

    Given IV

  • questionnaire administrationOther

    Ancillary studies

  • laboratory biomarker analysisOther

    Correlative studies

  • reverse transcriptase-polymerase chain reactionGenetic

    Also called RT-PCR

    Correlative studies

  • polymorphism analysisGenetic

    Correlative studies

Study groups in NCT01338792
Study groupRoleWhat they receive
Treatment (chemotherapy and enzyme inhibitor)ExperimentalPatients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Receives: Drug: oxaliplatin; Drug: pemetrexed disodium; Other: questionnaire administration; Other: laboratory biomarker analysis; Genetic: reverse transcriptase-polymerase chain reaction; Genetic: polymorphism analysis

What is being measured

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

  1. Best Overall Response

    For patients with measurable disease, the RECIST 1.0 criteria was used to determine response. Complete Response = disappearance of all target lesions, Partial Response = greater or equal to 30% decrease in sum of longest diameter or target lesions, Stable Disease = <30% decrease or <20% increase, Progressive Disease = greater or equal to 20% increase in longest diameter of target lesions. For patients who do not have measurable disease by RECIST, the response was based on PSA response defined by Prostate Cancer Working Group criteria (1999) as 50% reduction in PSA confirmed on a second measurement at least 4 weeks later.

    Measured: RECIST evaluation: Baseline, after every 2 courses, and then every 6 months after off-study, up to 1 year. PSA evaluation: baseline, day 1 of each course, final evaluation, and then every 6 months after off-study, up to 1 year

Secondary outcomes (2)

  1. Time to Disease Progression and Overall Survival

    Progression-free survival was defined as the time from the first infusion of study treatment to the date of radiographic disease progression according to RECIST 1.0, or until two consecutive PSA rises occurred with an absolute increase of 5 ng/mL and a 50% relative increase over baseline. For patients without documented disease progression, the date of death or last follow-up without disease progression was used.

    Measured: Baseline, after every 2 courses, and then every 6 months after off-study (RECIST) until progression; or baseline, day 1 of each course, at the final evaluation, and then every 6 months after off-study (PSA) until progression

  2. Number of Participants With Serious Adverse Events (SAEs)

    Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

    Measured: Baseline, days 1 and 7 of each course, and at last evaluation, up to 1 year

Timeline

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

  1. First posted20 Apr 2011 (estimated)
  2. Study startJun 2006
  3. Primary completionDec 2011
  4. Study completionDec 2012

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01338792
Sponsor's protocol ID
4P-05-7
Other IDs
NCI-2011-00500
Status last verified
Feb 2014
First submitted
15 Apr 2011
Last updated
10 Mar 2014
Data monitoring committee
Yes

Publications

  • Dorff TB, Tsao-Wei DD, Groshen S, Boswell W, Goldkorn A, Xiong S, Quinn DI, Pinski JK. Efficacy of oxaliplatin plus pemetrexed in chemotherapy pretreated metastatic castration-resistant prostate cancer. Clin Genitourin Cancer. 2013 Dec;11(4):416-22. doi: 10.1016/j.clgc.2013.07.011. Epub 2013 Oct 4.

    PubMed 24099865

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing oxaliplatin, pemetrexed disodium and questionnaire administration in people with Hormone-resistant Prostate Cancer and Recurrent Prostate Cancer, run by University of Southern California at 1 site 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 20 inclusion and 13 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 10 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 11 Dec 2013). 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 Response (time frame: RECIST evaluation: Baseline, after every 2 courses, and then every 6 months after off-study, up to 1 year. PSA evaluation: baseline, day 1 of each course, final evaluation, and then every 6 months after off-study, up to 1 year). 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 NCT01338792, 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 10 Mar 2014.

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