Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for MPM
Mesothelioma
About this trial
This is an interventional other trial for Mesothelioma
Eligibility Criteria
Inclusion Criteria:
Histologically proven malignant pleural mesothelioma MPM that is considered resectable according to the following criteria:
- Confined to one pleural space
- No chest wall invasion
- No transdiaphragmatic involvement
- No invasion of mediastinal structures
- Age ≥ 18 years
- Eastern Cooperative Oncology Group performance status 0-1 (Appendix A)
Adequate cardiopulmonary reserve defined as follows as assessed within 4 months of study entry:
- Predicted postoperative forced expiratory volume FEV1 > 1L
- Normal left ventricular function (Ejection Fraction EF ≥ 45%) and right ventricular function
- No pulmonary hypertension noted on preoperative transthoracic echocardiography
Must have adequate hematologic, renal and hepatic function as defined by the following laboratory values (completed within 60 days of surgery) Hematologic: Hemoglobin ≥ 9.0 g/dL, absolute neutrophil count (ANC) ≥ 1500/mm3, platelet count ≥ 100,000/mm Renal: Calculated creatinine clearance ≥ 60 mL/min
The creatinine clearance CrCl is determined by the Cockcroft-Gault formula:
Males:
Creatinine Clearance CrCl (mL)/min) = weight (kg) x (140-age) 72 x serum creatinine (mg/dL)
Females:
Creatinine Clearance CrCl (mL)/min) = weight (kg) x (140-age) x 0.85 72 x serum creatinine (mg/dL)
Hepatic: Total bilirubin < 1.5 times the upper limit of institutional normal value; Aspartate aminotransferase AST (Serum glutamic oxaloacetic transaminase SGOT) and alanine aminotransferase ALT (Serum glutamic pyruvic transaminase SGPT) < 3 times the upper limit of the institutional normal Coagulation: international normalized ratio INR ≤ 1.5 in patients not utilizing systemic anticoagulation as part of their medical regimen
- Women of child bearing potential and sexually active males must use an accepted and effective non-hormonal method of contraception
- Patients must be deemed by the investigators to be fully recovered from both acute and late effects of any prior surgery, radiotherapy, or other antineoplastic therapy
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- The ability to interrupt non-steroidal anti-inflammatory drugs NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Pemetrexed.
- The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.
Exclusion Criteria:
- Not pregnant or breastfeeding - the drugs used in this study are Pregnancy Category D (clear evidence of risk in pregnancy). A negative pregnancy test is required within 14 days of registration for pre- or perimenopausal (i.e., last menstrual period within one year of registration) women.
- Patients with a history of another neoplasm, with the exception of non-metastatic, non-melanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery or small field radiotherapy, within 5 years of registration will be excluded.
- Patients with uncontrolled cardiovascular disease (a history of hospitalization for acute myocardial infarction, arrhythmia, or congestive heart failure within 3 months prior to registration) will be excluded
- Registered patients with an active infection or with a fever of ≥ 38.5°C within 24 hours of the first scheduled day of protocol initiation will be excluded until their infection and/or fever resolves.
- Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
- Inability to interrupt use of non-steroidal anti-inflammatory drugs (NSAIDS)
- Peripheral neuropathy >/= Grade 2 (Common Terminology Criteria for Adverse Events CTCAE)
- Systemic chemotherapy within 3 weeks of registration
- Prior Allergies: History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin and pemetrexed
- Presence of third space fluid which cannot be controlled by drainage.
Sites / Locations
- Baylor St Lukes
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Pemetrexed (300 mg/m2) and Cisplatin (175 mg/m2)
Pemetrexed (400 mg/m2) and Cisplatin (175 mg/m2)
Pemetrexed and cisplatin will be admixed together in 1 liter of normal saline. The admixture of pemetrexed/cisplatin is stable for 4 hours and should be prepared and delivered immediately before use in the OR. The length of the pemetrexed/cisplatin lavage will be 1 hour.
Pemetrexed and cisplatin will be admixed together in 1 liter of normal saline. The admixture of pemetrexed/cisplatin is stable for 4 hours and should be prepared and delivered immediately before use in the OR. The length of the pemetrexed/cisplatin lavage will be 1 hour.