Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma


Phase 3
18 Years
N/A
Not Enrolling
Both
Malignant Mesothelioma

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Trial Information

Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jan P. Van Meerbeeck, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University Medical Center Rotterdam at Erasmus Medical Center

Authority:

United States: Federal Government

Study ID:

EORTC-08983

NCT ID:

NCT00004920

Start Date:

November 1999

Completion Date:

Related Keywords:

  • Malignant Mesothelioma
  • localized malignant mesothelioma
  • advanced malignant mesothelioma
  • recurrent malignant mesothelioma
  • Mesothelioma

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