Brief Title
Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
Official Title
Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma
Brief 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.
Detailed 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 Phase
Phase 3
Study Type
Interventional
Condition
Malignant Mesothelioma
Intervention
cisplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
256
Start Date
November 1999
Primary Completion Date
January 2003
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed malignant pleural mesothelioma
- No CNS metastases
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ZUBROD, ECOG, WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Hemoglobin at least 10.0 g/dL
- WBC at least 4,000/mm^3
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 1.46 mg/dL
- Albumin at least 3.0 g/dL
- ALAT/ASAT less than 2.5 times upper limit of normal (ULN) (less than 5 times ULN if
liver involvement)
Renal:
- Creatinine less than 1.69 mg/dL
- Creatinine clearance at least 65 mL/min
Cardiovascular:
- Not specified
Pulmonary:
- Not specified
Other:
- No other prior or concurrent malignancies within past 5 years except adequately
treated carcinoma in situ of the cervix or basal or squamous cell carcinoma of the
skin
- No prior malignant melanoma, hypernephroma or breast carcinoma
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study
- No uncontrolled infections
- No psychological, familial, sociological, or geographical condition that precludes
study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunotherapy before first disease progression
Chemotherapy:
- No prior systemic or intracavitary cytotoxic chemotherapy
- No other prior or concurrent chemotherapy before first disease progression
- No prior or concurrent pleurodesis with cytotoxic drugs (e.g., bleomycin)
Endocrine therapy:
- No concurrent hormonal therapy except corticosteroids before first disease progression
Radiotherapy:
- At least 4 weeks since prior radiotherapy to target lesion and progression observed
- Concurrent palliative radiotherapy to painful lesions allowed only if target lesion
outside of irradiated field
Surgery:
- Prior surgery allowed if followed by disease progression
Other:
- At least 1 month since prior investigational drugs
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jan P. Van Meerbeeck, MD, PhD, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT00004920
Organization ID
EORTC-08983
Secondary IDs
EORTC-08983
Responsible Party
Sponsor
Study Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor
Jan P. Van Meerbeeck, MD, PhD, Study Chair, University Medical Center Rotterdam at Erasmus Medical Center
Verification Date
July 2012