Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma
Status: | |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/16/2012 |
Start Date: | July 2010 |
End Date: | December 2013 |
Contact: | Jill Buck |
Email: | jbuck@ziopharm.com |
Phone: | 617-259-1984 |
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.
This is an international, randomized, double-blind, placebo-controlled trial to evaluate the
clinical efficacy of palifosfamide-tris administered with doxorubicin in combination,
compared with doxorubicin administered with placebo in front-line patients diagnosed with
metastatic soft tissue sarcoma (STS).
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.
We found this trial at
67
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