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Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00004920
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2012
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Tracking Information
First Submitted Date  ICMJE March 7, 2000
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date July 18, 2012
Study Start Date  ICMJE November 1999
Actual Primary Completion Date January 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE Malignant Mesothelioma
Intervention  ICMJE
  • Drug: cisplatin
  • Drug: raltitrexed
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July¬†17,¬†2012)
256
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Egypt,   France,   Germany,   Italy,   Netherlands,   Peru,   Poland,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00004920
Other Study ID Numbers  ICMJE EORTC-08983
EORTC-08983
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor  ICMJE European Organisation for Research and Treatment of Cancer - EORTC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jan P. Van Meerbeeck, MD, PhD University Medical Center Rotterdam at Erasmus Medical Center
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP