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Four Versus Six Cycles of Pemetrexed/Platinum for MPM

Primary Purpose

Malignant Pleural Mesothelioma

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
pemetrexed/platinum chemotherapy
Pemetrexed/platinum chemotherapy
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Pleural Mesothelioma focused on measuring MPM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ain Shams University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Four cycles of pemetrexed/platinum

Six cycles of pemetrexed/platinum

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Overall survival

Full Information

First Posted
July 10, 2015
Last Updated
July 13, 2015
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02497053
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Mesothelioma
Keywords
MPM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Four cycles of pemetrexed/platinum
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
Six cycles of pemetrexed/platinum
Intervention Type
Drug
Intervention Name(s)
pemetrexed/platinum chemotherapy
Intervention Description
Four cycles of pemetrexed/platinum chemotherapy
Intervention Type
Drug
Intervention Name(s)
Pemetrexed/platinum chemotherapy
Intervention Description
Six cycles of pemetrexed/platinum chemotherapy
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
one year
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologic or cytologic diagnosis of malignant pleural Mesothelioma No prior chemotherapy. ECOG less than or equal to 2 . Measurable disease according to the requirements of SWOG criteria. Age ≥ 18 years . Estimated life expectancy of at least 12 weeks . 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: Presence of central nervous system metastases. 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). Inadequate renal function (creatinine > 1.25 times UNL, creatinine clearance < 50mL/min). Serious concomitant systemic disorder incompatible with the study. 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). Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar Abdel-Rahman, MD
Phone
26858397
Email
omar.abdelrhman@med.asu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Abdel-Rahman, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar Abdel-Rahman, MD
Phone
26858397
Email
omar.abdelrhman@med.asu.edu.eg
First Name & Middle Initial & Last Name & Degree
Ahmed Nagi, MD
Email
ahmedalynagy@yahoo.com
First Name & Middle Initial & Last Name & Degree
Omar Abdel-Rahman, MD
First Name & Middle Initial & Last Name & Degree
Ahmed Nagi, MD

12. IPD Sharing Statement

Learn more about this trial

Four Versus Six Cycles of Pemetrexed/Platinum for MPM

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