Pemetrexed Disodium and Either Gemcitabine or Carboplatin in Treating Patients With Advanced Malignant Pleural Mesothelioma

This study is currently recruiting patients.
Verified by National Cancer Institute (NCI) July 2006

Sponsors and Collaborators:

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

North Central Cancer Treatment Group

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00101283

Purpose

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, gemcitabine, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving pemetrexed disodium with gemcitabine is more effective than giving pemetrexed disodium with carboplatin in treating malignant pleural mesothelioma.

PURPOSE: This randomized phase II trial is studying pemetrexed disodium and gemcitabine to see how well they work compared to pemetrexed disodium and carboplatin in treating patients with advanced malignant pleural mesothelioma.

Condition	Intervention	Phase
Advanced Malignant Mesothelioma Recurrent Malignant Mesotheliom	Drug: carboplatin Drug: gemcitabine hydrochloride Drug: pemetrexed disodium Procedure: chemotherapy	Phase II

MedlinePlus related topics: Cancer; Cancer Alternative Therapies; Mesothelioma
Genetics Home Reference related topics: Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Randomized Study of Pemetrexed Disodium Combined With Either Gemcitabine or Carboplatin in Patients With Advanced Malignant Mesothelioma of the Pleura

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

OBJECTIVES:

Primary

Compare the response rates in patients with advanced malignant mesothelioma of the pleura treated with pemetrexed disodium combined with either gemcitabine or carboplatin.

Secondary

Compare the relative toxic effects of these regimens in these patients.
Compare survival time in patients treated with these regimens.
Correlate smoking status with outcome in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on day 1.
Arm II: Patients receive pemetrexed disodium as in arm I and gemcitabine IV over 30 minutes on days 1 and 8.

In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Beginning approximately 5-10 days before the start of chemotherapy and continuing until approximately 3 weeks after completion of chemotherapy, all patients receive oral folic acid once daily and cyanocobalamin (vitamin B12) intramuscularly every 9 weeks.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 32-60 patients (16-30 per treatment arm) will be accrued for this study within 12.8-27.0 months.

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

DISEASE CHARACTERISTICS:

Cytologically confirmed advanced mesothelioma of the pleura
Measurable disease
Unmeasurable pleural rinds allowed provided disease is evaluable by mesothelioma response criteria
The following are not considered measurable disease:
Pleural effusions
Positive bone scans
Not a candidate for curative surgery
No known or suspected brain metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic

Bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement)
Albumin ≥ 2.5 g/dL

Renal

Creatinine clearance ≥ 45 mL/min OR
Creatinine ≤ 2.0 g/dL

Other

Able to take folic acid and cyanocobalamin (vitamin B12)
Willing and able to take dexamethasone
Not obviously malnourished
No weight loss > 10% within the past 6 weeks
No active infection
No other serious systemic disorder that would preclude study participation
No other malignancy within the past 3 years except carcinoma of the cervix or breast, other malignancies, or adequately treated basal cell skin cancer
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior intracavitary immunomodulators except for the purpose of pleurodesis

Chemotherapy

No prior systemic chemotherapy

Endocrine therapy

Not specified

Radiotherapy

Prior radiotherapy to the target lesion allowed provided both of the following criteria are met:
The lesion is clearly progressing after prior radiotherapy
At least 4 weeks since prior radiotherapy

Surgery

See Biologic therapy
More than 2 weeks since prior pleurodesis

Other

More than 4 weeks since prior investigational agents
No prior intracavitary cytotoxic drugs except for the purpose of pleurodesis
No aspirin or other nonsteroidal anti-inflammatory drugs for 2 days before, during, and for 2 days after each administration of pemetrexed disodium (5 days before, during, and 2 days after each administration of pemetrexed disodium for piroxicam, naproxen, diflunisal, or nabumetone)

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00101283

Delaware
Beebe Medical Center, Lewes, Delaware, 19958, United States; Recruiting

Clinical Trials Office - Beebe Medical Center 302-645-3171

CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States; Recruiting

Clinical Trial Office - CCOP - Christiana Care Health Services 302-733-6227

Florida
Baptist Cancer Institute - Jacksonville, Jacksonville, Florida, 32207, United States; Recruiting

Clinical Trials Office - Baptist Cancer Institute - Jacksonvil 904-202-7051

Georgia
Winship Cancer Institute of Emory University, Altanta, Georgia, 30322, United States; Recruiting

Dong M. Shin, MD 404-778-5990

Illinois
BroMenn Regional Medical Center, Normal, Illinois, 61761, United States; Recruiting