Treatment of malignant mesothelioma with pemetrexed (Alimta) + platinum (4 courses) or pemetrexed (Alimta) + platinum (4 courses) followed by Caelyx single drug (4 courses). - The Pea-Fowl Study

Active, not recruiting

• Conditions: Malignant pleural mesotelioma; MedDRA version: 9.1Level: LLTClassification code 10027407Term: Mesothelioma malignant

• Registration Number: EUCTR2007-005398-73-SE
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Patients may be included in the study only if they meet ALL of the following criteria:

1.Histologically (or cytologically if later confirmed by a mesothelioma panel) proven diagnosis of mesothelioma of the pleura, with subtyping (epitheloid, mixed, sarcomatous or not classifiable). Not a candidate for potentially curative surgery (see Appendix). All stages.

2.At least one unidimensionally measurable lesion(s) of the pleura with clearly defined margins by computerized tomography (CT) with a thickness of ³1 cm OR for example measurable lymph node(s) (or both). The CT scan should not be older than 28 days before start of treatment.

3.Patients may have undergone pleurodesis. If so, a minimum delay of 28 days must follow before study drugs are administered. If the original CT scan was performed prior to the pleurodesis, a new CT scan is required 28 or more days after the pleurodesis, which will then be considered the baseline scan.

4.Prior radiation therapy allowed to <25 % of the bone marrow. Prior radiotherapy must be completed at least 14 days before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.

5.WHO Performance status of 2 or lower (after any palliative measures including pleural drainage). Estimated life expectancy at least 8 weeks.

6.Patient compliance and geographic proximity allowing adequate follow-up.

7.Adequate organ function including the following:
Bone marrow: Leukocytes (WBC) ³3.0 ? 109/l. Platelets ?100 ? 109/l. Hemoglobin ?10 g/dl.
Hepatic: Bilirubin ? 1.5 times the upper limit of normal (ULN). Alkaline phosphatase, aspartate transaminase (AST) or alanine transaminase (ALT) ???? x ULN (alkaline phosphatase, AST, ALT ?5 x ULN is acceptable if tumour involvement of the liver).
Renal: Calculated creatinine clearance (CrCl) ?45 ml/min

8.Signed informed consent from patient.

9.> 18 years of age.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will not be enrolled if ANY of the following criteria apply:

1.Previous treatment with cytostatic chemotherapy within 5 years. Patients on low-dose methotrexate for rheumatoid arthritis or other diseases cannot be included.

2.Any other active malignant disease within 5 years, except basal or squamous cell carcinoma of the skin or cancer of the cervix Stage I.

3.Cardiomyopathy. Cardiac disease with a cardiac dysfunction NYHA class III or IV (Appendix).

4.History of severe hypersensitivity reactions to any of the trial drugs.

5.Clinically significant hepatic disease.

6.Uncontrolled bacterial, viral, or fungal infection.

7.Other serious concomitant systemic disorders that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator.

8.Patient is pregnant or breast-feeding. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment. Patient of childbearing potential should use contraceptive.

9.Confusion, disorientation, or any other condition (medical, social, and psychological) which could prevent adequate information and follow-up.

10.Inability to interrupt salicylates or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam).

11.Inability or unwillingness to take folic acid or vitamin B12 supplementation.

12.Treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Toxicity<br>Response<br>Duration of response<br>Time to tumour response<br>Quality of Life<br>Overall survival;Primary end point(s): Time to progression (TTP)<br>Duration of response<br>Duration of overall survival;Main Objective: To compare time to progression (TTp) with the pre-determined in the two treatment arms (Alimta + platinum drug or Alimta + platinum drug followed by Caelyx single drug).