Pemetrexed Plus Gemcitabine or Carboplatin for Patients With Advanced Malignant Pleural Mesothelioma
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, gemcitabine, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving pemetrexed disodium with gemcitabine is more effective than giving pemetrexed disodium with carboplatin in treating malignant pleural mesothelioma. PURPOSE: This randomized phase II trial is studying pemetrexed disodium with gemcitabine and pemetrexed disodium with carboplatin to see how well the combinations work compared to historical controls in treating patients with advanced malignant pleural mesothelioma.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jul 3, 2023 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Eastern Cooperative Oncology Group
- Interventions being studied
- Drug: pemetrexed disodium; Drug: gemcitabine hydrochloride; Drug: carboplatin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Histologically or cytologically confirmed advanced mesothelioma of the pleura
- Measurable disease, as defined by RECIST criteria, within 4 weeks of randomization. Patients with pleural rinds not measurable by RECIST were eligible if disease was evaluable within 4 weeks of randomization using mesothelioma response criteria
- May have undergone pleurodesis. If pleurodesis was performed, there must have been at least a 2-week delay before Pemetrexed administration. A CT must have been performed after 2 weeks after pleurodesis to serve as the baseline scan.
- ECOG Performance Status of 0 or 1
- Normal organ and marrow function, as defined by:
- Absolute neutrophil count ≥ 1,500/ul
- Platelet count ≥ 100,000/ul
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement)
- Albumin ≥ 2.5 g/dL
- Creatinine clearance ≥ 45 mL/min or Creatinine ≤ 2.0 g/dL
- Age 18 years and over
- Able to take folic acid and cyanocobalamin (vitamin B12)
- Willing and able to take dexamethasone
- Women of childbearing potential and sexually active men were required to use contraception during and for the first 3 months after the study
- A candidate for curative surgery
- Prior radiation therapy to the target lesion, unless the lesion was clearly progressing per RECIST criteria after prior radiation and the interval between the most recent radiation therapy and enrollment was at least 4 weeks
- Prior systemic chemotherapy for mesothelioma. Prior intracavitary cytotoxic drugs or immunomodulators were not permitted, unless given for the purpose of pleurodesis.
- Active infection or serious concomitant systemic disorder
- Second primary malignancy, other than in situ malignancies or adequately treated basal cell carcinoma of the skin or other malignancy treated at least 3 years previously with no evidence of recurrence.
- Treatment with an investigational agent within 4 weeks before enrollment
- Known or suspected brain metastases
- Women must not be pregnant or breastfeeding
- Obviously malnourished or with a weight loss of greater than 10% in the preceding 6 weeks
- Aspirin or other nonsteroidal anti-inflammatory drugs for 2 days before, during, and for 2 days after each administration of pemetrexed disodium (5 days before, during, and 2 days after each administration of pemetrexed disodium for piroxicam, naproxen, diflunisal, or nabumetone)
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut
- Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware
- CCOP - Christiana Care Health ServicesNewark, Delaware
- Mayo Clinic - JacksonvilleJacksonville, Florida
- Winship Cancer Institute of Emory UniversityAtlanta, Georgia
- Rush-Copley Cancer Care CenterAurora, Illinois
- St. Joseph Medical CenterBloomington, Illinois
- Graham HospitalCanton, Illinois
- Memorial HospitalCarthage, Illinois
- Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois
- Eureka Community HospitalEureka, Illinois
- Galesburg Clinic, PCGalesburg, Illinois
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 3, 2023. Always confirm current availability with the study team.