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Cisplatin With or Without Pemetrexed Disodium in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery
This study has been completed.
First Received: May 2, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005636
  Purpose

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 if cisplatin is more effective with or without pemetrexed disodium for malignant mesothelioma of the pleura.

PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin with or without pemetrexed disodium in treating patients who have malignant mesothelioma of the pleura that cannot be removed by surgery.


Condition Intervention Phase
Malignant Mesothelioma
Drug: cisplatin
Drug: pemetrexed disodium
Phase III

MedlinePlus related topics: Cancer Mesothelioma Surgery
Drug Information available for: Cisplatin Pemetrexed Pemetrexed disodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: A Single-Blind Randomized Phase III Trial of MTA Plus Cisplatin Versus Cisplatin in Patients With Malignant Pleural Mesothelioma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 1999
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005636

Locations
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: David H. Ilson, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067791, MSKCC-99085, CWRU-LILY-1599, LILLY-H3E-MC-JMCH(a), NCI-G00-1767
Study First Received: May 2, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005636     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma

Study placed in the following topic categories:
Antimetabolites
Folic Acid
Pemetrexed
Radiation-Sensitizing Agents
Cisplatin
Mesothelioma
Folic Acid Antagonists
Adenoma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Pemetrexed
Neoplasms
Cisplatin
Radiation-Sensitizing Agents
Therapeutic Uses
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009