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Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for Malignant Pleural Mesotheliomas

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ClinicalTrials.gov Identifier: NCT02838745
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Shawn Groth, Baylor College of Medicine

Brief Summary:

Primary Objective

To determine the maximum tolerated dose (MTD) of intrathoracic administration of pemetrexed when given in conjunction with cisplatin in patients with resectable malignant pleural mesothelioma MPM.

Secondary Objectives

To determine the toxicity and grades associated with cytoreductive surgery and Hyperthermic Intraoperative Chemotherapy HIOC with cisplatin and pemetrexed in patients with resectable MPM.

To assess overall survival and progression-free survival after PD or EPP and HIOC with cisplatin and pemetrexed for MPM

Correlative Objectives

To characterize the pharmacokinetics and pharmacodynamics of pemetrexed when administered as a hyperthermic intrathoracic lavage after PD or EPP

To determine whether the degree of thymidylate synthase and ERCC1 gene expression in MPM tissue correlates with clinical response to pemetrexed.


Condition or disease Intervention/treatment Phase
Mesothelioma Drug: Pemetrexed Drug: Cisplatin Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Phase I Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for Malignant Pleural Mesotheliomas
Study Start Date : September 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Mesothelioma

Arm Intervention/treatment
Experimental: Pemetrexed and Cisplatin
• 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.
Drug: Pemetrexed
Drug: Cisplatin



Primary Outcome Measures :
  1. Safety Maximum Tolerated Dose of HIOC with cisplatin and pemetrexed for Malignant Pleural Mesothelioma. [ Time Frame: 1 Month ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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
  2. Age ≥ 18 years
  3. Eastern Cooperative Oncology Group performance status 0-1 (Appendix A)
  4. 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
  5. 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

  6. Women of child bearing potential and sexually active males must use an accepted and effective non-hormonal method of contraception
  7. 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
  8. 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.
  9. 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.
  10. The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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
  4. 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.
  5. 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.
  6. Inability to interrupt use of non-steroidal anti-inflammatory drugs (NSAIDS)
  7. Peripheral neuropathy Grade 2 (Common Terminology Criteria for Adverse Events CTCAE)
  8. Systemic chemotherapy within 3 weeks of registration
  9. Prior Allergies: History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin and pemetrexed
  10. Presence of third space fluid which cannot be controlled by drainage.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838745


Contacts
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Contact: Michelle G Almarez, BBA 713-798-3680 Michelle.Almarez@bcm.edu
Contact: Shawn Groth, MD 713-798-86281

Locations
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United States, Texas
Baylor St Lukes Recruiting
Houston, Texas, United States, 77030
Contact: Michelle G Almarez, BBA    713-798-3680    Michelle.Almarez@bcm.edu   
Contact: Bryan Burt, MD    713-798-8266    Bryan.Burt@bcm.edu   
Principal Investigator: Bryan Burt, MD         
Sponsors and Collaborators
Baylor College of Medicine

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Responsible Party: Shawn Groth, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02838745     History of Changes
Other Study ID Numbers: H-36460
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
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Mesothelioma
Fever
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Body Temperature Changes
Signs and Symptoms
Cisplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors