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Pemetrexed Plus Gemcitabine Or Carboplatin In Patients With Advanced Malignant Mesothelioma: A Randomized Phase II Trial


Phase 2
18 Years
N/A
Not Enrolling
Both
Mesothelioma

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Trial Information

Pemetrexed Plus Gemcitabine Or Carboplatin In Patients With Advanced Malignant Mesothelioma: A Randomized Phase II Trial


OBJECTIVES:

Primary

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

Secondary

- Assess the toxic effects of these regimens in these patients.

- Estimate 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. While randomized, the study is not a comparative study. Rather, outcomes
on each arm will be compared to a historical control rate from previous studies.
Randomization allows simultaneous testing of two experimental arms.

- Arm I: Patients receive intravenous (IV) pemetrexed disodium 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.


Inclusion Criteria:



- Histologically or cytologically confirmed advanced mesothelioma of the pleura

- Measurable disease, as defined by RECIST criteria, within 4 weeks of randomization.
Patients with pleural rinds not measurable by RECIST were eligible if disease was
evaluable within 4 weeks of randomization using mesothelioma response criteria

- May have undergone pleurodesis. If pleurodesis was performed, there must have been
at least a 2-week delay before Pemetrexed administration. A CT must have been
performed after 2 weeks after pleurodesis to serve as the baseline scan.

- ECOG Performance Status of 0 or 1

- Normal organ and marrow function, as defined by:

- Absolute neutrophil count ≥ 1,500/ul

- Platelet count ≥ 100,000/ul

- 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

- Creatinine clearance ≥ 45 mL/min or Creatinine ≤ 2.0 g/dL

- Age 18 years and over

- Able to take folic acid and cyanocobalamin (vitamin B12)

- Willing and able to take dexamethasone

- Women of childbearing potential and sexually active men were required to use
contraception during and for the first 3 months after the study

Exclusion Criteria

- A candidate for curative surgery

- Prior radiation therapy to the target lesion, unless the lesion was clearly
progressing per RECIST criteria after prior radiation and the interval between the
most recent radiation therapy and enrollment was at least 4 weeks

- Prior systemic chemotherapy for mesothelioma. Prior intracavitary cytotoxic drugs or
immunomodulators were not permitted, unless given for the purpose of pleurodesis.

- Active infection or serious concomitant systemic disorder

- Second primary malignancy, other than in situ malignancies or adequately treated
basal cell carcinoma of the skin or other malignancy treated at least 3 years
previously with no evidence of recurrence.

- Treatment with an investigational agent within 4 weeks before enrollment

- Known or suspected brain metastases

- Women must not be pregnant or breastfeeding

- Obviously malnourished or with a weight loss of greater than 10% in the preceding 6
weeks

- 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best Overall Response by RECIST Criteria (Version 1.0)

Outcome Description:

Number of eligible, treated participants in each response category by RECIST criteria. Response categories represent best response for each patient prior to progression.

Outcome Time Frame:

Assessed every 2 cycles (6 weeks) while on treatment, then every 3 months for 2 years, then every 6 months for 1 year until disease progression

Safety Issue:

No

Principal Investigator

Nasser H. Hanna, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000401795

NCT ID:

NCT00101283

Start Date:

November 2005

Completion Date:

May 2011

Related Keywords:

  • Mesothelioma
  • advanced malignant mesothelioma
  • recurrent malignant mesothelioma
  • Mesothelioma

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Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Hurley Medical CenterFlint, Michigan  48503
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - DuluthDuluth, Minnesota  55805-1983
CCOP - DuluthDuluth, Minnesota  55805
Miller - Dwan Medical CenterDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's HospitalSt Paul, Minnesota  55102
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
HealthEast Cancer Care at Woodwinds Health CampusWoodbury, Minnesota  55125
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
St. Rita's Medical CenterLima, Ohio  45801
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
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Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Lewistown HospitalLewistown, Pennsylvania  17044
Mount Nittany Medical CenterState College, Pennsylvania  16803
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
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Galesburg Cottage HospitalGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
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BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
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Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Bismarck Cancer CenterBismarck, North Dakota  58501
Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut  06360
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
William N. Wishard Memorial HospitalIndianapolis, Indiana  46202
McFarland Clinic, PCAmes, Iowa  50010
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Foote Memorial HospitalJackson, Michigan  49201
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Galesburg Clinic, PCGalesburg, Illinois  61401
Trinity Cancer Center at Trinity Medical Center - 7th Street CampusMoline, Illinois  61265
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Medcenter One Hospital Cancer Care CenterBismarck, North Dakota  58501
St. Alexius Medical Center Cancer CenterBismarck, North Dakota  58502