Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00004920
Study type Interventional
Source European Organisation for Research and Treatment of Cancer - EORTC
Contact
Status Completed
Phase Phase 3
Start date November 1999

See also
  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 NCT00513877 - Bortezomib in Treating Patients With Malignant Pleural 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
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