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

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Brief Title

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

Official Title

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

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.
    

Detailed Description

      TREATMENT PLAN

      PREOPERATIVE HYDRATION According to our observations, preoperative hydration reduces the risk
      of nephrotoxicity from intrathoracic infusion of hyperthermic cisplatin. Therefore, all
      patients will be admitted the night before surgery and receive intravenous hydration.

      CYTOREDUCTIVE SURGERY

      Eligible patients will undergo an extrapleural pneumonectomy (EPP) or
      pleurectomy/decortication (PD) by a Baylor College of Medicine board-certified thoracic
      surgeon. Patients will be given ondansetron 8mg x 1 dose after induction of anesthesia,
      before initiation of chemotherapy lavage. The anti-emetics will be adjusted if grade III
      toxicity is still encountered. Patients will then undergo cytoreductive surgery (PD or EPP)
      with curative intent. In the event that not all of the tumor can be removed then the
      investigators will allow a total of 1 cm3 or less of disease in one or more areas. If the
      tumor is unresectable and debulking cannot be obtained, then the patient will receive
      additional treatment off protocol. Mediastinal lymph node sampling will be performed. In the
      event that the diaphragm and pericardium are resected, they will be reconstructed with
      polytetrafluoroethylene (PTFE).

      RENAL PROTECTION STRATEGY

      The investigators will continue our established perioperative renal protection strategy to
      minimize the risk of cisplatin-induced nephrotoxicity.

      Perioperative Intravenous Hydration:

      The patient will be admitted the night before surgery for intravenous hydration.

      During the operation, the anesthesiologist will monitor urine output. At his or her
      discretion, diuretics, renal dose dopamine, or fluid challenge will be instituted to maintain
      the urine output at least 100 cc per hour.

      In the immediate postoperative setting, the patient will be aggressively hydrated; a
      pulmonary artery catheter will be used to guide management. Cisplatin-induced diuresis (more
      than 100 cc per hour) will be replaced with crystalloid for the first 24 hours after surgery
      at the following rate: 1cc crystalloid per 1cc of urine after PD and 0.5cc crystalloid per
      1cc of urine after EPP.

      Amifostine and Sodium Thiosulfate Per Protocol.

      HEATED INTRAOPERATIVE CHEMOTHERAPY PERFUSION

      The procedure is as follows:

        -  After the cancer resection is complete, the perfusion cannulae will be placed within the
           open hemithorax.

        -  A total of three temperature probes will be placed within the hemithorax or upper
           abdomen (via the chest since the diaphragm is no longer present after most PDs and after
           all EPPs) and the esophagus.

        -  Another two temperature probes will be used to monitor the temperature of the solution
           in the circuit.

        -  An open well will be created over the thoracotomy using an Omni tract retractor, using
           monofilament suture between the skin edges and the retractor, and enclosing the area
           with a plastic covering.

        -  A slit in the plastic cover is made just large enough to allow the surgeon's
           double-gloved hand into the hemithorax to evenly distribute the perfusate. The surgeon
           gently (but repeatedly) manipulates all exposed areas to allow uniform distribution of
           the heated chemotherapy.

        -  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.

        -  A roller pump forces the heated chemotherapy into the chest and abdomen through the
           inflow cannula and pulls it out via an outflow cannula.

        -  If the perfusate solution does not fill the chest cavity, one or more intact bags of
           saline will be placed in the chest cavity to displace the perfusate. In this manner, the
           chest cavity can be filled without diluting the perfusate.

        -  A heat exchanger keeps the fluid being infused at 43-45 degrees Celsius so that the
           intrathoracic fluid is 42 degrees Celsius.

        -  A smoke evacuator is used to pull air from beneath the plastic cover through activated
           charcoal, preventing any possible contamination of air in the operating room by
           chemotherapy aerosols.

      Pharmacokinetics will be drawn per protocol.

      Dose Levels

      Cohort Pemetrexed Dose A 300 mg/m2 B 400 mg/m2 C 500 mg/m2 D 600 mg/m2 E 700 mg/m2 F 800
      mg/m2 Stop to Analyze Safety G 900 mg/m2 H 1000 mg/m2 Stop to Analyze Safety

      The standard dose of pemetrexed for systemic administration is 500 mg/m2. However, because
      pemetrexed has not been previously studied for direct administration into the chest, the
      initial cohorts will receive a slightly lower dose to ensure this method of administering
      pemetrexed is safe. Once safety has been established at lower doses, the investigators will
      feel confident that pemetrexed intrathoracic doses that are slightly higher than the standard
      systemic dose (500 mg/m2) can be given safely. In animal models, these higher doses resulted
      in a systemic concentration of pemetrexed (which is correlated with systemic toxicities) that
      is potentially lower after intracavitary infusion than after systemic administration 2. These
      higher doses may result in superior long-term clinical outcomes.

      Schedule Assignment for Dose Levels

      Patients will be enrolled in cohorts of 3 according the dose escalation/de-escalation rules
      specified. For the purposes of executing the dose escalation scheme, toxicity will be
      assessed until 4 weeks after treatment. Additional patient cohorts will not be enrolled until
      all toxicity evaluable patients treated at the current dose have completed the observation
      period. In addition, the investigators will pause after completion of the 800 mg/m2, if the
      MTD is not reached, to assure that delayed toxicities don't manifest. If the MTD is not
      exceeded at the highest dose level, the escalation schedule may be expanded.

      Dose limiting toxicity (DLT) is defined as:

        -  Grade 4 treatment-related hematologic toxicity that lasts more than for 5 days or grade
           3 thrombocytopenia with grade 3 or 4 bleeding

        -  Febrile neutropenia

        -  Grade 3 or greater treatment related non-hematologic toxicity with the following
           exceptions:

             -  Grade 3 diarrhea is a DLT only if the patient was compliant with an anti-diarrheal
                program consistent with best clinical practice

             -  Grade 3 or 4 nausea and vomiting is a DLT only if the patient was compliant with an
                antiemetic program consistent with best clinical practice

             -  Alopecia

      Supportive Care Guidelines All supportive measures consistent with optimal patient care will
      be given throughout the study.

      Duration of Therapy

      Patients will receive protocol therapy unless:

        1. Extraordinary medical circumstances: If at any time the constraints of this protocol are
           detrimental to the patient's health, protocol treatment will be discontinued

        2. Patient withdraws consent

        3. There is evidence of progressive disease or unacceptable toxicity

        4. The treating physician thinks a change of therapy would be in the best interest of the
           patient

      Follow-up All patients, including those who discontinue protocol therapy early, will be
      followed by their oncologist or primary care providers. The date of death will be recorded.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Safety Maximum Tolerated Dose of HIOC with cisplatin and pemetrexed for Malignant Pleural Mesothelioma.


Condition

Mesothelioma

Intervention

Pemetrexed

Study Arms / Comparison Groups

 Pemetrexed and Cisplatin
Description:  • 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

36

Start Date

September 2016

Completion Date

August 2022

Primary Completion Date

July 2022

Eligibility 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.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, 713-798-3680, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02838745

Organization ID

H-36460


Responsible Party

Principal Investigator

Study Sponsor

Baylor College of Medicine


Study Sponsor

, , 


Verification Date

March 2020