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A Multi-center, Open-Label, Adaptive, Randomized Study of Palifosfamide-tris, a Novel DNA Crosslinker, in Combination With Carboplatin and Etoposide (PaCE) Chemotherapy Versus Carboplatin and Etoposide (CE) Alone in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer. The MATISSE Study


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Extensive-Stage Small Cell Lung Cancer

Thank you

Trial Information

A Multi-center, Open-Label, Adaptive, Randomized Study of Palifosfamide-tris, a Novel DNA Crosslinker, in Combination With Carboplatin and Etoposide (PaCE) Chemotherapy Versus Carboplatin and Etoposide (CE) Alone in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer. The MATISSE Study


Inclusion Criteria:



- Documented extensive-stage small cell lung cancer.

- Patient has received no prior chemotherapy, adjuvant therapy, or radiotherapy for
lung cancer.

- ECOG Performance Status of 0, 1 or 2.

- Adequate bone marrow and organ function based on the results of protocol- specified
laboratory tests.

- Male and female patients must agree to use a highly reliable method of birth control
during study participation.

- Able to provide informed consent

Exclusion Criteria:

- Previously untreated (non-irradiated), symptomatic brain metastases.

- Known allergy to any of the study drugs or their excipients.

- Any unstable or clinically significant concurrent medical condition that would, in
the opinion of the investigator, jeopardize the safety of a patient and/or their
compliance with the protocol, based on screening tests, physical examination and
medical history (as specifically defined in the clinical protocol).

- Any malignancy other than small cell lung cancer within the last 5 years prior to
randomization, with the exception of cervical carcinoma in situ, nonmelanoma skin
cancer, or superficial bladder tumors (Ta, Tis, or T1) that have been successfully
and curatively treated with no evidence of recurrent or residual disease. (Exception:
Subjects with a history of malignancy other than small cell lung cancer may be
enrolled after consultation with the medical monitor provided the patient's prognosis
is best defined by the extensive-stage small cell lung cancer).

- Currently pregnant or nursing.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Survival (OS)

Outcome Time Frame:

Assessed every 12 weeks for survival until 1 year following completion of enrollment

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

IPM3002

NCT ID:

NCT01555710

Start Date:

May 2012

Completion Date:

June 2015

Related Keywords:

  • Extensive-Stage Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Fletcher Allen Health CareBurlington, Vermont  05401
Rush University Medical CenterChicago, Illinois  60612-3824
Virginia Piper Cancer InstituteMinneapolis, Minnesota  55407
Central Baptist HospitalLexington, Kentucky  40503
Montefiore Medical CenterBronx, New York  10467-2490
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Frederick Memorial Hospital Regional Cancer Therapy CenterFrederick, Maryland  21701
Medical Oncology, LLCBaton Rouge, Louisiana  70808
Swedish Medical CenterSeattle, Washington  98122-4307
John Theurer Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
Texas Oncology, PADallas, Texas  75246-2006
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Medical Oncology Associates of Wyoming Valley, PCKingston, Pennsylvania  18704
Hematology Oncology Associates of the Treasure CoastPort St. Lucie, Florida  34952
Indiana UniversityIndianapolis, Indiana  46202
University of Southern CaliforniaLos Angeles, California  90033
Medical and Surgical Specialists, LLCGalesburg, Illinois  61401
University of Kansas HospitalKansas City, Kansas  66160
Saint Mary's Medical CenterDuluth, Minnesota  55805
Birmingham Hematology and Oncology Associates, LLCBirmingham, Alabama  35235
New York Oncology Hematology, PCAlbany, New York  12208
Fairfax Northern Virginia Hematology-Oncology, PCFairfax, Virginia  22031
Baptist Cancer InstituteJacksonville, Florida  32207
Christiana Care Health ServicesNewark, Delaware  19713
Horizon Oncology CenterLafayette, Indiana  47905
University of Texas Medical Branch at GalvestonGalveston, Texas  77555
The Christ HospitalCincinnati, Ohio  45219
Charleston Hematology Oncology Associates, PACharleston, South Carolina  29403
Oncology Consultants, PAHouston, Texas  77024
Peachtree Hematology Oncology ConsultantsAtlanta, Georgia  30309
Goshen Center for Cancer CareGoshen, Indiana  46526
Illinois Cancer SpecialistsNiles, Illinois  60714
Texas Oncology-Medical City DallasDallas, Texas  75230-2510
Indiana University Health Ball Memorial HospitalMuncie, Indiana  47303
Metro Health Cancer CenterWyoming, Michigan  49519
Redwood Regional Oncology GroupSanta Rosa, California  95403
Hematology Oncology Associates of Northern New Jersey, PA, Carol G. Simon Cancer CenterMorristown, New Jersey  07962
Dayton Cancer Center, Medical Oncology Hematology AssociatesDayton, Ohio  45429
Texas Oncology- Baylor, Charles A. Sammons Cancer CenterDallas, Texas  75246
Wisconsin Institutes for Medical ResearchMadison, Wisconsin  53705