MesotheliomaPhase 1NCT02838745
Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for MPM
A Phase 1 study testing Pemetrexed and Cisplatin in people with Mesothelioma, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mesothelioma
- What is being tested?
- Pemetrexed and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 5 Sep 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 23Show fewer
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for Malignant Pleural Mesotheliomas
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.
Read more
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.
Read the 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:
- Extraordinary medical circumstances: If at any time the constraints of this protocol are detrimental to the patient's health, protocol treatment will be discontinued
- Patient withdraws consent
- There is evidence of progressive disease or unacceptable toxicity
- 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.
- Conditions
- Mesothelioma
- Being tested
- Pemetrexed, Cisplatin
- Medical subject headings
- Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
CisplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Pemetrexed (300 mg/m2) and Cisplatin (175 mg/m2) | Experimental | 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. Receives: Drug: Pemetrexed; Drug: Cisplatin |
| Pemetrexed (400 mg/m2) and Cisplatin (175 mg/m2) | Experimental | 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. Receives: Drug: Pemetrexed; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose-Limiting Toxicity (DLT)
Dose limiting toxicity (DLT) is defined as: 1) Grade 4 treatment-related hematologic toxicity that lasts more than for 5 days or grade 3 thrombocytopenia with grade 3 or 4 bleeding, 2) Febrile neutropenia, 3) Grade 3 or greater treatment related non-hematologic toxicity with the following exceptions:Grade 3 diarrhea is a dose limiting toxicity 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 dose limiting toxicity DLT only if the patient was compliant with an antiemetic program consistent with best clinical practice; Alopecia
Measured: from the first day of treatment until 4 weeks after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startSep 2016
- Primary completion5 Sep 2019
- Study completion5 Sep 2019
Why it stopped: Change in research plan.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MesotheliomaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawn Groth, Baylor College of Medicine
- Investigators
- Shawn Groth, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838745
- Sponsor's protocol ID
- H-36460
- Status last verified
- Mar 2022
- First submitted
- 16 Jul 2016
- Last updated
- 31 Mar 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for Malignant Pleural Mesotheliomas
- ClinicalTrials.gov ID
- NCT02838745
- Acronym / sponsor ID
- H-36460
- Conditions
- Mesothelioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in research plan.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Extraordinary medical circumstances: If at any time the constraints of this protocol are detrimental to the patient's health, protocol treatment will be discontinued
- Patient withdraws consent
- There is evidence of progressive disease or unacceptable toxicity
- 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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pemetrexed (300 mg/m2) and Cisplatin (175 mg/m2) | Experimental | Drug: Pemetrexed, Drug: CisplatinPemetrexed 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 (400 mg/m2) and Cisplatin (175 mg/m2) | Experimental | Drug: Pemetrexed, Drug: CisplatinPemetrexed 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Histologically proven malignant pleural mesothelioma MPM that is considered resectable according to the following criteria:
- 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:
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pemetrexed | Drug | Pemetrexed (300 mg/m2) and Cisplatin (175 mg/m2), Pemetrexed (400 mg/m2) and Cisplatin (175 mg/m2) |
| Cisplatin | Drug | Pemetrexed (300 mg/m2) and Cisplatin (175 mg/m2), Pemetrexed (400 mg/m2) and Cisplatin (175 mg/m2) |
Primary outcome
Number of participants with Dose-Limiting Toxicity (DLT)
Time frame: from the first day of treatment until 4 weeks after the treatment
Dose limiting toxicity (DLT) is defined as: 1) Grade 4 treatment-related hematologic toxicity that lasts more than for 5 days or grade 3 thrombocytopenia with grade 3 or 4 bleeding, 2) Febrile neutropenia, 3) Grade 3 or greater treatment related non-hematologic toxicity with the following exceptions:Grade 3 diarrhea is a dose limiting toxicity 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 dose limiting toxicity DLT only if the patient was compliant with an antiemetic program consistent with best clinical practice; Alopecia
Results and safety
The study was stopped early (reason given: Change in research plan.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn Groth, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pemetrexed and Cisplatin in people with Mesothelioma, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Change in research plan.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Dose-Limiting Toxicity (DLT) (time frame: from the first day of treatment until 4 weeks after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.