Four Versus Six Cycles of Pemetrexed/Platinum for MPM

Brief Title

Four Versus Six Cycles of Pemetrexed/Platinum for MPM

Official Title

Four Versus Six Cycles of Pemetrexed/Platinum as a First Line Treatment of Malignant Pleural Mesothelioma; a Randomized Phase II Study

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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Progression free survival

Secondary Outcome

 Overall survival

Condition

Malignant Pleural Mesothelioma

Intervention

pemetrexed/platinum chemotherapy

Study Arms / Comparison Groups

 Arm A

Description:  Four cycles of pemetrexed/platinum

Publications

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

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

June 2015

Primary Completion Date

June 2016

Eligibility 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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Omar Abdel-Rahman, MD, 26858397, [email protected]

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations

NCT ID

NCT02497053

Organization ID

Meso-01

Responsible Party

Principal Investigator

Study Sponsor

Ain Shams University

Study Sponsor

Omar Abdel-Rahman, MD, Principal Investigator, Ain Shams University

Verification Date

July 2015