Four Versus Six Cycles of Pemetrexed/Platinum for MPM

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

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Overall survival [ Time Frame: 3 years ]

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

• Principal Investigator: Omar Abdel-Rahman, MD; Ain Shams University

More Information

• 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
• Last Update Posted: July 14, 2015
• Last Verified: July 2015

Keywords provided by Omar Abdel-Rahman, Ain Shams University:

MPM

Additional relevant MeSH terms:

Mesothelioma; Mesothelioma, Malignant; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pemetrexed; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors