Malignant Mesothelioma Clinical Trial
Official title:
Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. It is not yet known whether receiving cisplatin with
raltitrexed is more effective than cisplatin alone for malignant mesothelioma.
PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin with or
without raltitrexed in treating patients who have malignant mesothelioma of the pleura.
OBJECTIVES:
- Compare overall survival in patients with malignant pleural mesothelioma treated with
raltitrexed with or without cisplatin.
- Assess toxicity, progression free survival, and quality of life with these treatment
regimens in these patients.
- Evaluate objective response and duration of response to these treatment regimens in
patients with measurable disease.
OUTLINE: This is a randomized, open, multicenter study. Patients are stratified according to
performance status (0 vs 1-2) and WBC count (less than 8,300/mm3 vs 8,300/mm3 or more).
Patients are randomized to one of two treatment arms.
- Arm I: Patients receive cisplatin IV over 1-2 hours on day 1.
- Arm II: Patients receive raltitrexed IV over 15 minutes followed by cisplatin IV over
1-2 hours on day 1.
Treatment continues every 3 weeks in the absence of disease progression or unacceptable
toxicity.
Quality of life is assessed before study, prior to each course, after the last course, and
then every 6 weeks for 1 year.
Patients are followed every 6 weeks until death.
PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study over 24 months.
;
Allocation: Randomized, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06057935 -
A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma
|
Phase 2 | |
| Completed |
NCT00821860 -
Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma
|
Phase 3 | |
| Completed |
NCT00075699 -
Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma
|
Phase 3 | |
| Completed |
NCT00004033 -
Liposomal-Cisplatin Analogue (L-NDDP) in Treating Patients With Malignant Pleural Mesothelioma
|
Phase 2 | |
| Active, not recruiting |
NCT03678350 -
Light Dosimetry for Photodynamic Therapy With Porfimer Sodium in Treating Participants With Malignant Mesothelioma or Non-Small Cell Lung Cancer With Pleural Disease Undergoing Surgery
|
Phase 1 | |
| Recruiting |
NCT02580747 -
Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART-meso
|
Phase 1 | |
| Completed |
NCT00398138 -
Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma
|
Phase 1 | |
| Completed |
NCT00019825 -
Decitabine in Treating Patients With Unresectable Lung or Esophageal Cancer or Malignant Mesothelioma of the Pleura
|
Phase 1 | |
| Terminated |
NCT00898547 -
Biomarkers of Angiogenesis and Disease in Patients With Unresectable Malignant Mesothelioma Treated on Clinical Trial CALGB-30107
|
||
| Active, not recruiting |
NCT00030459 -
Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma
|
Phase 2 | |
| Completed |
NCT00004183 -
Capecitabine in Treating Patients With Malignant Mesothelioma
|
Phase 2 | |
| Completed |
NCT00005636 -
Cisplatin With or Without Pemetrexed Disodium in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery
|
Phase 3 | |
| Completed |
NCT00004254 -
Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed
|
Phase 2 | |
| Completed |
NCT00334594 -
Pemetrexed Disodium and Cisplatin Followed by Surgery With or Without Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma
|
Phase 2 | |
| Completed |
NCT01291420 -
Dendritic Cell Vaccination for Patients With Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03852823 -
Study of Recombinant Human Anti-PD-1 Monoclonal Antibody in Patients With Advanced Tumours
|
Phase 1 | |
| Active, not recruiting |
NCT01649024 -
A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma
|
Phase 2 | |
| Completed |
NCT00372840 -
Printed Education Materials in Patients Who Are Finishing Treatment for Stage I, Stage II, or Stage IIIA Breast Cancer, Colorectal Cancer, Prostate Cancer, or Chest Cancer
|
N/A | |
| Completed |
NCT00513877 -
Bortezomib in Treating Patients With Malignant Pleural Mesothelioma
|
Phase 2 | |
| Active, not recruiting |
NCT00253409 -
Combination Chemotherapy With or Without Surgery and Radiation Therapy in Treating Patients With Mesothelioma That Can Be Removed By Surgery
|
N/A |