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A Phase III Multicenter, International, Randomized, Double-blind, Placebo-controlled Study of Doxorubicin Plus Palifosfamide-tris vs. Doxorubicin Plus Placebo in Patients With Front-line Metastatic Soft Tissue Sarcoma.


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Soft Tissue Sarcoma

Thank you

Trial Information

A Phase III Multicenter, International, Randomized, Double-blind, Placebo-controlled Study of Doxorubicin Plus Palifosfamide-tris vs. Doxorubicin Plus Placebo in Patients With Front-line Metastatic Soft Tissue Sarcoma.

Inclusion Criteria


To be eligible, each patient must meet EACH of the following criteria:

- Age ≥18 years.

- Documented soft tissue sarcoma

- Metastatic disease for which the patient has not received any prior treatment, and
for whom treatment with doxorubicin is considered medically acceptable.

- 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

To be eligible, each patient must meet NONE of the following criteria:

- Specific sarcoma histological subtypes including GIST and Ewing's sarcoma.

- Systemic therapy for the treatment of metastatic sarcoma, prior to or during the
study. However, patients may have received neo-adjuvant/adjuvant Gemzar and Taxotere
chemotherapy for their primary sarcoma, prior to the development of metastatic
disease

- Any prior anthracycline use.

- 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).

- Myocardial dysfunction defined as left ventricular ejection fraction (LVEF) <50%.

- Documented metastases to brain or meninges.

- Any malignancy other than sarcoma within the last 5 years prior to screening, with
the exception of cervical carcinoma in situ, basal cell carcinoma, or superficial
bladder tumors (Ta, Tis, or T1) that have been successfully and curatively treated
with no evidence of recurrent or residual disease.

- Currently pregnant or nursing.

- Radiotherapy with curative intent within 4 weeks of first dose of study drug.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival followed by Overall Survival

Outcome Time Frame:

assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months/until progression, then every 12 weeks until then death

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

IPM3001

NCT ID:

NCT01168791

Start Date:

July 2010

Completion Date:

December 2013

Related Keywords:

  • Soft Tissue Sarcoma
  • Metastatic
  • Front line
  • Sarcoma

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Mayo ClinicRochester, Minnesota  55905
University of Colorado Cancer CenterDenver, Colorado  80262
Washington University School of MedicineSaint Louis, Missouri  63110
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Mount Sinai School of MedicineNew York, New York  10029
Hinsdale, Illinois  60521
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Summa Health SystemAkron, Ohio  44312
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Cancer Therapy and Research CenterSan Antonio, Texas  78229
Rocky Mountain Cancer CentersThornton, Colorado  80260
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Medical College of GeorgiaAugusta, Georgia  30912
University of PittsburghPittsburgh, Pennsylvania  15261
University of North CarolinaChapel Hill, North Carolina  27599
Cancer Care AssociatesTulsa, Oklahoma  74136
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Flint, Michigan  48532
University of RochesterRochester, New York  14642
Hackensack, New Jersey  07601
Albuquerque, New Mexico  87131-5636
Arizona Oncology AssociatesTucson, Arizona  85712-2254
Cleveland ClinicCleveland, Ohio  44195
Metairie, Louisiana  70006
Baltimore, Maryland  21287
Charlotte, North Carolina  
South Burlington, Vermont  
Milwaukee, Wisconsin  
Charleston, South Carolina  
University of California, Los AngelesLos Angeles, California  
Texas OncologyDallas, Texas  
Providence, Rhode Island  02908
Washington, District of Columbia  
Las Vegas, Nevada  89109
UC Cancer InstituteCincinnati, Ohio  45267
Moffitt Cancer CenterTampa, Florida  33612
Oregon Health and Science UniversityPortland, Oregon  97201
University of California, IrvineOrange, California  92868
Utah Cancer SpecialistsSalt Lake City, Utah  84106
Medical Oncology Hematology ConsultantsNewark, Delaware  19808
University of WisconsinMadison,, Wisconsin  53792-5666
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
The Ohio State University Medical CenterColumbus, Ohio  43210
University of Washington/Seattle Cancer Care AllianceSeattle, Washington  98109
Columbia University Medical CenterNew York, New York  10032
Kansas City Cancer CenterKansas City, Kansas  66112
University of Iowa Hospital and ClinicsIowa City, Iowa  52242
Kootenai Cancer CenterPost Falls, Idaho  83854
Sarcoma Oncology CenterSanta Monica, California  90403
Indiana University Simon Cancer CenterIndianapolis, Indiana  46202
LSU Health Sciences Center, Feist-Weiller Cancer CenterShreveport, Louisiana  71130
Pennsylvania Oncology/Hematology AssociatesPhiladelphia, Pennsylvania  19106
MedStar Research InstituteWashington, District of Columbia  
EmoryAtlanta, Georgia  
St.Louis UniversitySt. Louis, Missouri  63110
Saint BarnabasWest Orange, New Jersey  
Texas Oncology - Medical City DallasDallas, Texas  
Virginia Cancer SpecialistsFairfax, Virginia  
Bellin Cancer CenterGreen Bay, Wisconsin  54313