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Four Versus Six Cycles of Pemetrexed/Platinum for MPM

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ClinicalTrials.gov Identifier: NCT02497053
Recruitment Status : Unknown
Verified July 2015 by Omar Abdel-Rahman, Ain Shams University.
Recruitment status was:  Recruiting
First Posted : July 14, 2015
Last Update Posted : July 14, 2015
Sponsor:
Information provided by (Responsible Party):
Omar Abdel-Rahman, Ain Shams University

Brief Summary:

The prognosis of mesothelioma is generally poor. The median survival of patients with unresectable malignant mesothelioma ranges approximately between 6-12 months. Survival is poor because there is no curative treatment.

Treatment options include surgery, chemotherapy and radiotherapy. Recently multimodality treatment regimens have been reported to prolong survival. Other new therapeutic approaches include immunotherapy, gene therapy, hyperthermic chemoperfusion of the pleura and photodynamic therapy, but the results have not yet been completely validated. Even with the introduction of this new therapeutic protocol, the response does not exceed 41%, with a mean survival of 12 months. The current standard of care for unresectable malignant pleural mesothelioma is pemetrexed/cisplatin. This regimen was compared to cisplatin alone in a study including 448 patients from 19 countries which was the largest trial to date among patients suffering from malignant mesothelioma. Results showed statistically significant increase in overall survival by about 30 % (12.1 months for pemetrexed /cisplatin versus 9.3 months for cisplatin alone. In addition, there was an improvement in lung function (forced vital capacity) in the pemetrexed /cisplatin arm in comparison to the cisplatin arm.

Until now, however, there is no consensus on the number of cycles of pemetrexed/cisplatin in malignant mesothelioma and there are no approved predictive markers for response.

Pemetrexed/cisplatin regimen is an expensive regimen and associated with considerable toxicity and so we need to rationalize its use in our Egyptian patients.

Therefore, the investigators aim in this work to compare 4 cycles versus 6 cycles of pemetrexed/cisplatin in malignant mesothelioma and to identify a predictive marker for response.


Condition or disease Intervention/treatment Phase
Malignant Pleural Mesothelioma Drug: pemetrexed/platinum chemotherapy Drug: Pemetrexed/platinum chemotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Four Versus Six Cycles of Pemetrexed/Platinum as a First Line Treatment of Malignant Pleural Mesothelioma; a Randomized Phase II Study
Study Start Date : June 2015
Estimated Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arm Intervention/treatment
Experimental: Arm A
Four cycles of pemetrexed/platinum
Drug: pemetrexed/platinum chemotherapy
Four cycles of pemetrexed/platinum chemotherapy

Active Comparator: Arm B
Six cycles of pemetrexed/platinum
Drug: Pemetrexed/platinum chemotherapy
Six cycles of pemetrexed/platinum chemotherapy




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologic or cytologic diagnosis of malignant pleural Mesothelioma
  2. No prior chemotherapy.
  3. ECOG less than or equal to 2 .
  4. Measurable disease according to the requirements of SWOG criteria.
  5. Age ≥ 18 years .
  6. Estimated life expectancy of at least 12 weeks .
  7. Adequate bone marrow reserve (white blood cells [WBC] ≥ 3.5 × 109 /L, neutrophils ≥ 1.5 × 109 /L, platelets ≥ 100 × 109 /L, and hemoglobin ≥ 9.0 gm/dL).

Exclusion Criteria:

  1. Presence of central nervous system metastases.
  2. Inadequate liver function (bilirubin > 1.5 times upper normal limit [UNL] and alanine transaminase [ALT] or aspartate transaminase [AST] > 3.0 UNL or up to 5.0 UNL in the presence of hepatic metastases).
  3. Inadequate renal function (creatinine > 1.25 times UNL, creatinine clearance < 50mL/min).
  4. Serious concomitant systemic disorder incompatible with the study.
  5. Second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior to enrollment without recurrence).
  6. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497053


Contacts
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Contact: Omar Abdel-Rahman, MD 26858397 omar.abdelrhman@med.asu.edu.eg

Locations
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Egypt
Ain Shams University Hospitals Recruiting
Cairo, Egypt
Contact: Omar Abdel-Rahman, MD    26858397    omar.abdelrhman@med.asu.edu.eg   
Contact: Ahmed Nagi, MD       ahmedalynagy@yahoo.com   
Principal Investigator: Omar Abdel-Rahman, MD         
Sub-Investigator: Ahmed Nagi, MD         
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Omar Abdel-Rahman, MD Ain Shams University
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Responsible Party: Omar Abdel-Rahman, Lecturer of clinical Oncology, Faculty of medicine, Ain Shams University, Ain Shams University
ClinicalTrials.gov Identifier: NCT02497053    
Other Study ID Numbers: Meso-01
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: July 2015
Keywords provided by Omar Abdel-Rahman, Ain Shams University:
MPM
Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors