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MesotheliomaPhase 2NCT00895648

Pemetrexed (ALIMTA) Plus Cisplatin Followed by Surgery and Radiation Therapy for Mesothelioma

A Phase 2 study testing Pemetrexed and Cisplatin in people with Mesothelioma and Pleural Mesothelioma, run by University Health Network, Toronto at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Despite the best surgical efforts, complete removal of mesothelioma is possible in approximately 30% of the patients. When surgical removal is complete, chemotherapy followed by radiation therapy is recommended as an effort to improve control over the cancer and survival. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mesothelioma, Pleural Mesothelioma
What is being tested?
Pemetrexed and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteCanada
Study dates
Jan 2009to Oct 2012
Phase
Phase 2
Are there results?
None posted in the registry

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven diagnosis of MPM stages I to III. Patients will be clinically staged using the AJCC/UICC TNM staging criteria (see Protocol Appendix 2). Eligible stages:
  • Patients must be M0.
  • Patients with T1, T2, and T3 disease (without cardiac involvement) are eligible. T status can be established clinically and radiologically or at exploratory thoracotomy without surgical resection.
  • Patients with N0, N1, or N2 disease are eligible.
  • Performance status of 0 to 2 on the ECOG performance status schedule. See protocol Appendix 3
  • No prior systemic chemotherapy. No prior intracavitary cytotoxic drugs or immunomodulators, unless given for the purpose of chemical pleurodesis.
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  • No previous surgical procedure for mesothelioma, with the exception of previous chemical pleurodesis and biopsy.
  • No previous radiation therapy for mesothelioma, or to the thorax.
  • Patients must be judged to be suitable candidates for this therapy at the UHN by the attending medical oncologist, thoracic surgeon, and radiation oncologist before enrolment.
  • Estimated life expectancy of at least 12 weeks.
  • Adequate organ function including the following:
  • Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ³1,500/uL , platelets ³100,000/uL, hemoglobin ³ 9g/dL
  • Hepatic: bilirubin £1.5 times institutional upper limit of normal, alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) £3 times institutional upper limit of normal
  • Renal: Creatinine £1.5 times institutional upper limit of normal; or Creatinine clearance ³50 mL/min/1.73 m² for patients with creatinine levels above institutional normal upper limit level. Cockcrot and Gault formula Appendix 4.
  • Pulmonary function tests:
  • Predicted post-operative DLCO (ppoDLCO) of > 35%.
  • If the ppoDLCO is </= 35%, then additional studies will be done to determine the patient's ability to tolerate the resection. The surgeon will correlate these results with the patient's clinical status and make a decision as to the feasibility of resection.
  • Female patients of childbearing potential must test negative for pregnancy at the time of enrolment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of radiation therapy.
  • Patients must sign an informed consent

Who cannot join

  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Have previously completed or withdrawn from this study or any other study investigating pemetrexed
  • Pregnancy or breast-feeding.
  • Serious concomitant systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
  • Second active primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanomatous carcinoma of the skin, low grade (Gleason score < 6) localized adenocarcinoma of the prostate or other malignancy treated at least 2 years previously with no evidence of recurrence.
  • Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8 day period for long-acting agents such as piroxicam).
  • Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone.
  • Refusal to have any of the treatment in the protocol (chemotherapy, extrapleural pneumonectomy, and radiation therapy).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University Health Network

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: Phase II Study of Neo-adjuvant Pemetrexed (ALIMTA) Plus Cisplatin Followed by Surgery and Radiation Therapy for Malignant Pleural Mesothelioma

Despite the best surgical efforts, complete removal of mesothelioma is possible in approximately 30% of the patients. When surgical removal is complete, chemotherapy followed by radiation therapy is recommended as an effort to improve control over the cancer and survival. This combination of treatments is called TRIMODALITY therapy. Unfortunately, the chances for the tumor coming back after TRIMODALITY therapy remains high. When surgical removal is not complete or not possible, some patients may receive chemo and/or radiation therapy to achieve control over the cancer, but the chances of tumor to growth again remains high and the chances of long term survival remains low.

The combination of Pemetrexed (Alimta) with Cisplatin has been approved as one of the standard chemotherapy drug combinations for the treatment in advanced Malignant Pleural Mesothelioma, and there is likely a group of patients who may benefit and potentially be cured by this therapy. In an effort to achieve a better chance of complete removal of the cancer and long term survival, the investigators are interested in using this drug combination of Pemetrexed + Cisplatin before surgery and offer radiation therapy after surgery.

Being tested
Pemetrexed, Cisplatin
Keywords
Meso, mesothelioma, pleura, pleural
Medical subject headings
Mesothelioma, Mesothelioma, Malignant

What participants receive

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

  • PemetrexedDrug

    Also called Alimta

    500 mg/m² iv infusion every 3 weeks for 3 cycles

  • CisplatinDrug

    75 mg/m² iv infusion every 3 weeks for 3 cycles

Study groups in NCT00895648
Study groupRoleWhat they receive
Alimta plus CisplatinExperimentalNot described
Receives: Drug: Pemetrexed; Drug: Cisplatin

What is being measured

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

  1. median relapse-free survival (RFS)

    Measured: 15 months

Timeline

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

  1. First posted8 May 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionOct 2012
  4. Study completionOct 2012

Why it stopped: low accrual due to competing study for same group of patients

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00895648
Sponsor's protocol ID
05-0815-C
Status last verified
May 2017
First submitted
6 May 2009
Last updated
4 May 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pemetrexed and Cisplatin in people with Mesothelioma and Pleural Mesothelioma, run by University Health Network, Toronto at 1 site in Canada.

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 19 inclusion and 8 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: stopped early, as of the sponsor's last update on 4 May 2017. 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 Canada. 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?

The study was stopped early (reason given: low accrual due to competing study for same group of patients). Results are not available in the source record.

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?

median relapse-free survival (RFS) (time frame: 15 months). 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 NCT00895648.

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 4 May 2017.

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