64 Participants Needed

Chemotherapy for Mesothelioma

Recruiting at 12 trial locations
GN
MO
Overseen ByMichael Offin, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking an oral medication that cannot be substituted and must be held for up to ten days, it may be considered an unacceptable risk by the investigator.

What data supports the effectiveness of the drug combination of pemetrexed and platinum analogs for treating malignant pleural mesothelioma?

Research shows that using pemetrexed with platinum drugs like cisplatin or carboplatin can improve survival in patients with malignant pleural mesothelioma. In one study, patients treated with cisplatin and pemetrexed lived longer than those treated with cisplatin alone, with survival increasing from 9.3 to 12.1 months.12345

Is chemotherapy with pemetrexed and platinum-based drugs safe for humans?

Pemetrexed, often combined with cisplatin or carboplatin, is generally considered safe for treating malignant pleural mesothelioma, but it can cause side effects like low blood cell counts, tiredness, nausea, and vomiting. Patients are advised to take folic acid and vitamin B12 to reduce severe side effects, and corticosteroids to prevent skin rashes.23678

How does the drug pemetrexed differ from other treatments for mesothelioma?

Pemetrexed is unique because it is often used in combination with platinum-based drugs like cisplatin or carboplatin, which can improve survival in mesothelioma patients. It is a key component in chemotherapy regimens and has been shown to be effective both as a single agent and in combination, making it a cornerstone in the treatment of this aggressive cancer.12349

What is the purpose of this trial?

The purpose of this study is to find out whether intraperitoneal or intravenous chemotherapy given after cytoreductive surgery and HIPEC are effective treatments for people with malignant peritoneal mesothelioma. Outcomes will be compared by observing intraperitoneal versus intravenous treatments to analyze if one is better than the other.

Research Team

GN

Garrett Nash, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer

Eligibility Criteria

This trial is for adults with malignant peritoneal mesothelioma who've had surgery to remove most of the cancer. They need good liver and kidney function, no severe unrelated medical issues, not pregnant or breastfeeding, and can't have used certain chemotherapies before.

Inclusion Criteria

My liver functions well, with bilirubin levels within the normal range.
I agree to use reliable barrier contraception throughout the study.
I am fully active and can carry on all my pre-disease activities without restriction.
See 9 more

Exclusion Criteria

My blood pressure is higher than 140/90 and I'm not cleared for surgery.
I am currently pregnant or breastfeeding.
My biopsy shows I have a specific type of mesothelioma.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cytoreductive Surgery and HIPEC

Participants undergo cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy

1-2 weeks

Treatment

Participants receive either intravenous or intraperitoneal chemotherapy. Intravenous chemotherapy involves 4 to 6 cycles of pemetrexed and cisplatin, while intraperitoneal chemotherapy involves administration through an intraperitoneal port.

12-18 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 24 months

Treatment Details

Interventions

  • Carboplatin
  • Cisplatin
  • Pemetrexed
Trial Overview The study tests if chemotherapy given directly into the abdomen (intraperitoneal) or through a vein (intravenous) after surgery helps patients more. It compares these two methods post-surgery to see which one might be more effective.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: IVC armExperimental Treatment3 Interventions
Pemetrexed and cisplatin will be administered intravenously for a total of 4 to 6 cycles. Participants will receive 4 cycles, but can receive up to 6 cycles based on clinician discretion. Substitution with carboplatin allowed for pre-existing impairment of hearing, renal function, or neuropathy.
Group II: NIPC armActive Control3 Interventions
After completion of hyperthermic intraperitoneal chemotherapy/HIPEC, an intraperitoneal catheter with a subcutaneous reservoir will be inserted through the abdominal wall. When the participant's condition is considered stable by the physicians, the NIPC will be started. Pemetrexed and either cisplatin or carboplatin will be administered through the intraperitoneal port.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Findings from Research

In a study of 49 patients with malignant pleural mesothelioma, the combination of carboplatin and pemetrexed achieved a disease control rate of 69% and a median overall survival of 14 months, indicating its effectiveness as a treatment option.
The treatment was generally well-tolerated, with only 14.3% of patients experiencing severe haematological toxicities and 24.5% experiencing severe non-haematological toxicities, and no toxic deaths reported.
Carboplatin and pemetrexed in the management of malignant pleural mesothelioma: a realistic treatment option?Li, L., Razak, AR., Hughes, A.[2015]
In a study involving 812 patients with malignant pleural mesothelioma (MPM), single-agent pemetrexed showed promising efficacy, with a median time to progressive disease of 6.0 months for chemonaïve patients and an overall response rate of 10.5%.
The treatment was well-tolerated, exhibiting mild hematologic toxicity, primarily neutropenia, in less than 18% of patients, indicating a favorable safety profile for pemetrexed in this patient population.
Single-agent pemetrexed for chemonaïve and pretreated patients with malignant pleural mesothelioma: results of an International Expanded Access Program.Taylor, P., Castagneto, B., Dark, G., et al.[2015]
In a study of 51 patients with malignant pleural mesothelioma, both pemetrexed with carboplatin (AC) and pemetrexed with cisplatin (AP) were found to be effective neoadjuvant chemotherapy regimens, with similar rates of disease control and surgical resection (81% for AC and 79% for AP).
However, the AP regimen was associated with a higher incidence of severe side effects, such as grade 3 anemia and increased fatigue, which could negatively affect patients' overall health and their ability to undergo surgery.
Pemetrexed plus carboplatin or cisplatin as neoadjuvant treatment of operable malignant pleural mesothelioma (MPM).Pasello, G., Marulli, G., Polo, V., et al.[2015]

References

Carboplatin and pemetrexed in the management of malignant pleural mesothelioma: a realistic treatment option? [2015]
Single-agent pemetrexed for chemonaïve and pretreated patients with malignant pleural mesothelioma: results of an International Expanded Access Program. [2015]
Pemetrexed plus carboplatin or cisplatin as neoadjuvant treatment of operable malignant pleural mesothelioma (MPM). [2015]
Overview on ongoing or planned clinical trials in Europe. [2015]
Pemetrexed in the treatment of malignant mesothelioma: results from an expanded access program in Germany. [2015]
FDA drug approval summaries: pemetrexed (Alimta). [2022]
Safety and effectiveness of pemetrexed in patients with malignant pleural mesothelioma based on all-case drug-registry study. [2015]
The effectiveness and safety of platinum-based pemetrexed and platinum-based gemcitabine treatment in patients with malignant pleural mesothelioma. [2022]
[Mesothelioma: advances in chemotherapy]. [2007]
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