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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

Primary Purpose

Malignant Mesothelioma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
cisplatin
pemetrexed disodium
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Mesothelioma focused on measuring localized malignant mesothelioma, advanced malignant mesothelioma, recurrent malignant mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Institute of New Jersey
  • Memorial Sloan-Kettering Cancer Center
  • Ireland Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 2, 2000
Last Updated
June 17, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005636
Brief Title
Cisplatin With or Without Pemetrexed Disodium in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery
Official Title
A Single-Blind Randomized Phase III Trial of MTA Plus Cisplatin Versus Cisplatin in Patients With Malignant Pleural Mesothelioma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
November 1999 (undefined)
Primary Completion Date
November 2000 (Actual)
Study Completion Date
November 2000 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Mesothelioma
Keywords
localized malignant mesothelioma, advanced malignant mesothelioma, recurrent malignant mesothelioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
pemetrexed disodium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H. Ilson, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States

12. IPD Sharing Statement

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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

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