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

Brief Title

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

Official Title

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

Brief 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. 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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

median relapse-free survival (RFS)

Condition

Mesothelioma

Intervention

Pemetrexed

Study Arms / Comparison Groups

 Alimta plus Cisplatin

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

6

Start Date

January 2009

Completion Date

October 2012

Primary Completion Date

October 2012

Eligibility Criteria

        Inclusion Criteria:

          1. 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.

          2. Performance status of 0 to 2 on the ECOG performance status schedule. See protocol
             Appendix 3

          3. No prior systemic chemotherapy. No prior intracavitary cytotoxic drugs or
             immunomodulators, unless given for the purpose of chemical pleurodesis.

          4. No previous surgical procedure for mesothelioma, with the exception of previous
             chemical pleurodesis and biopsy.

          5. No previous radiation therapy for mesothelioma, or to the thorax.

          6. 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.

          7. Estimated life expectancy of at least 12 weeks.

          8. 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 					

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ron Feld, MD, , 

Location Countries

Canada

Location Countries

Canada

NCT ID

NCT00895648

Organization ID

05-0815-C

Responsible Party

Sponsor

Study Sponsor

University Health Network, Toronto

Collaborators

 Eli Lilly and Company

Study Sponsor

Ron Feld, MD, Principal Investigator, University Health Network, Toronto

Verification Date

May 2017