A Single-Blind Randomized Phase III Trial of MTA Plus Cisplatin Versus Cisplatin in Patients With Malignant Pleural Mesothelioma
18 Years
N/A
Both
Malignant Mesothelioma
Trial Information
A Single-Blind Randomized Phase III Trial of MTA Plus Cisplatin Versus Cisplatin in Patients With Malignant Pleural Mesothelioma
OBJECTIVES: I. Compare survival in patients with malignant pleural mesothelioma when treated
with cisplatin with or without LY231514. II. Compare duration of response, time to
progression, and time to treatment failure in these patients with these treatment regimens.
III. Compare tumor response rate and clinical benefit of these treatment regimens in these
patients. IV. Compare Lung Cancer Symptom Scale scores, pulmonary function test scores, and
lung density determinations with these treatment regimens in these patients. V. Compare
toxicity of these treatment regimens in these patients. VI. Assess pharmacokinetics and
vitamin metabolite status with these treatment regimens in these patients.
OUTLINE: This is a randomized, single blind, multicenter study. Patients are stratified
according to performance status (Karnofsky 70-80% vs 90-100%), degree of measurability
(bidimensional vs unidimensional only), histologic subtype (epithelial vs all others), WBC
(8,300/mm3 and higher vs less than 8,300/mm3), pain intensity (low vs high), analgesic
consumption (low vs high), dyspnea (low vs high), homocysteine (low vs high), gender,
country, and treatment center. Patients are randomized to one of two treatment arms. Arm I:
Patients receive LY231514 IV over 10 minutes followed by cisplatin IV over 2 hours on day 1.
Arm II: Patients receive cisplatin as in arm I. Treatment repeats every 21 days for at least
6 courses in the absence of disease progression or unacceptable toxicity. Patients are
followed at 4 weeks, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 280 patients (140 per treatment arm) will be accrued for this
study within 15 months.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant mesothelioma of the pleura not
amenable to curative surgery Must be radiologically accessible Unidimensionally or
bidimensionally measurable disease Pleural effusions or positive bone scan not considered
measurable No brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no
greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase, AST, and ALT no
greater than 3.0 times ULN (no greater than 5 times ULN with liver involvement) Albumin at
least 3.0 g/dL Renal: Creatinine clearance at least 45 mL/min Other: No serious systemic
disorders that may preclude study No prior primary malignancy within the past 5 years
except carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the
skin No obvious malnourishment or greater than 10% weight loss within 6 weeks prior to
study No active infection Not pregnant or nursing Fertile patients must use effective
contraception during and for 3 months after study
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior immunomodulators allowed for pleurodesis
No concurrent immunotherapy Chemotherapy: No prior systemic chemotherapy At least 1 week
since prior bleomycin for pleurodesis Prior intracavitary cytotoxic drugs allowed for
pleurodesis No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal
anticancer therapy Radiotherapy: At least 4 weeks since prior radiotherapy to target
lesion Lesion must be clearly progressive No concurrent radiotherapy Surgery: See Disease
Characteristics No concurrent surgery for cancer Other: At least 4 weeks since any other
prior investigational agent No concurrent aspirin or other nonsteroidal antiinflammatory
drug from 2 days prior to 2 days after study (5 days prior for long acting agents such as
piroxicam, naproxen, diflunisal, or nabumetone) No other concurrent experimental
medications
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
David H. Ilson, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
99-085
NCT ID:
NCT00005636
Start Date:
November 1999
Completion Date:
November 2000
Related Keywords:
- Malignant Mesothelioma
- localized malignant mesothelioma
- advanced malignant mesothelioma
- recurrent malignant mesothelioma
- Mesothelioma
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
| Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
