A Study of Palifosfamide Tris Plus Doxorubicin Versus Doxorubicin in Unresectable or Metastatic Soft-tissue Sarcoma
Information source: Ziopharm
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Soft Tissue Sarcoma
Intervention: Palifosfamide Tris and Doxorubicin (Drug); Doxorubicin (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Ziopharm Official(s) and/or principal investigator(s): Jonathan J Lewis, MD, PhD, Study Director, Affiliation: ZIOPHARM Oncology, Inc
Summary
This is a randomized, controlled trial to evaluate the clinical benefit of palifosfamide
tris administered with doxorubicin in combination, compared with single-agent doxorubicin
administered in subjects diagnosed with unresectable or metastatic soft-tissue sarcoma
(STS). Subjects who meet the entry criteria will be randomized into 1 of 2 arms: either to
receive palifosfamide tris plus doxorubicin or treatment with single-agent doxorubicin.
Subjects will be anthracyclin naïve.
Clinical Details
Official title: A Phase II Multicenter, Parallel Group, Randomized Study of Palifosfamide Tris Plus Doxorubicin Versus Doxorubicin in Subjects With Unresectable or Metastatic Soft-tissue Sarcoma
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The primary efficacy analysis will be conducted on the intent-to-treat (ITT) population. All attempts will be made to conduct assessment of disease status every 6 weeks until progression of disease or initiating off protocol anti cancer therapies.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age ≥18 years
2. Histological or cytological documentation of sarcoma (excluding alveolar
soft-part sarcoma, chondrosarcoma, dermatofibrosarcoma, Ewing sarcoma, GIST, Kaposi
sarcoma, mixed mesodermal tumor, osteosarcoma, radiation induced sarcomas, and
unresectable low grade liposarcoma) who have failed ≤2 prior regimens including
adjuvant therapy, or ≤1 prior regimen for metastatic/unresectable disease, and for
whom treatment with doxorubicin is considered medically acceptable. Prior treatment
with IFOS is acceptable.
3. Have measurable disease as per RECIST criteria (Appendix 2)
4. ECOG Performance Status of 0 or 1 (Appendix 3)
5. Anthracyclin naïve
6. Life expectancy of ≥12 weeks
7. Adequate bone marrow, liver, and renal function, as assessed by the following
laboratory requirements conducted within 14 days prior to dosing:
1. Hemoglobin ≥9. 0 g/dL
2. Absolute neutrophil count (ANC) ≥1,500/mm3
3. Platelet count 100,000/mm3
4. Total bilirubin ≤1. 5×ULN (upper limit of normal)
5. ALT and AST ≤2. 5×ULN or 5×ULN with hepatic disease
6. Partial thromboplastin [PT]-INR/activated partial thromboplastin time [PTT]
<1. 5×ULN (≤2. 0×ULN for subjects on anticoagulation prophylactic regimen).
Subjects who are being therapeutically anticoagulated with an agent such as
Coumadin (warfarin sodium) or heparin are allowed provided there is no prior
evidence of underlying abnormality in coagulation parameters. If an interaction
between study drug and anticoagulant is suspected, anticoagulation monitoring
should be increased as appropriate.
7. Serum creatinine ≤ULN
8. Written informed consent must be obtained from a potential subject prior to the
conduct of any study-specific procedures
9. Male and female subjects must agree to use adequate birth control measures/barrier
control during the course of the trial
10. Women of childbearing potential must have a urine pregnancy test performed within 14
days of the start of treatment
Exclusion Criteria:
1. Has any one of the following sarcoma sub types: alveolar soft-part sarcoma,
chondrosarcoma, dermatofibrosarcoma, Ewing sarcoma, GIST, Kaposi sarcoma, mixed
mesodermal tumor, osteosarcoma, radiation induced sarcomas, and unresectable low
grade liposarcoma.
2. Clinically evident congestive heart failure >Class II of the New York Heart
Association (NYHA) guidelines (Appendix 4)
3. Serious, clinically significant cardiac arrhythmias, defined as the existence of an
absolute arrhythmia, or ventricular arrhythmias classified as Lown III, IV, or V
(Appendix 4)
4. History and/or signs of active coronary artery disease/ischemia with or without
angina pectoris
5. Serious myocardial dysfunction defined as scintigraphically (MUGA [multiple gated
acquisition scan], myocardial scintigram) or ultrasound-determined absolute left
ventricular ejection fraction (LVEF) <45%
6. History of HIV infection
7. Prior nephrectomy or history of urinary tract obstruction
8. Active, clinically serious infection requiring systemic antibacterial, antifungal, or
antiviral therapy
9. Any major surgery within 3 weeks prior to start of treatment
10. Metastatic brain or meningeal tumors, unless the subject is >6 months from definitive
therapy and has a negative imaging study within 4 weeks of study entry. In addition,
the subject must not be undergoing acute steroid therapy or taper (chronic steroid
therapy is acceptable, provided the dose is stable for 1 month prior to study start,
and following screening radiographic studies).
11. Previous malignancy (except cervical carcinoma in situ, adequately treated basal cell
carcinoma, or superficial bladder tumors [Ta, Tis, & T1] or other malignancies
curatively treated >5 years prior to entry)
12. Pregnancy or lactation
13. Substance abuse or medical, psychological, or social conditions that may interfere
with the subject's participation in the study or evaluation of the study results
14. Any condition that is unstable or could jeopardize the safety of a subject and
his/her compliance with the protocol requirements
In addition, use of the following therapies and medications—prior or
concomitant—would exclude a subject from this study:
15. Anticancer chemotherapy, immunotherapy, or any investigational drug therapy during
the study or within 4 weeks of study entry (6 weeks for Mitomycin C)
16. Prior treatment with doxorubicin
17. Radiotherapy within 4 weeks of study entry (palliative radiation to bone lesions is
permitted if started or planned prior to Cycle 1, Day 1)
18. Bone marrow transplant or stem cell rescue within 4 months of study entry
19. Growth factors such as G-CSF (granulocyte colony-stimulating factor/filgrastim), or
biological response modifiers within 3 weeks of study entry
Locations and Contacts
Milan, Italy
Padova, Italy
Torino, Italy
Cluj-Napoca 400015, Romania
Lasi, Romania
Santa Monica, California, United States
Washington, District of Columbia, United States
Tampa, Florida, United States
Coeur d'Alene, Idaho 83814, United States
Chicago, Illinois, United States
Park Ridge, Illinois, United States
Iowa city, Iowa, United States
Lenaxa, Kansas, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Durham, North Carolina, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Additional Information
Starting date: August 2008
Last updated: January 29, 2014
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