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Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma (PICASSO III)

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ClinicalTrials.gov Identifier: NCT01168791
Recruitment Status : Completed
First Posted : July 23, 2010
Last Update Posted : July 18, 2013
Sponsor:
Information provided by (Responsible Party):
Ziopharm

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Drug: doxorubicin in combination with palifosfamide-tris Drug: doxorubicin in combination with placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 447 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : July 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: doxorubicin plus palifosfamide-tris Drug: doxorubicin in combination with palifosfamide-tris

palifosfamide-tris: 150 mg/m2 3 days every 21 days for a maximum of 6 cycles.

doxorubicin: 75 mg/m2 1 day every 21 days for a maximum of 6 cycles.
Active Comparator: doxorubicin plus placebo Drug: doxorubicin in combination with placebo

doxorubicin: 75 mg/m2 of doxorubicin 1 day every 21 days for a maximum of 6 cycles.

placebo: 250 mL of normal saline 3 days every 21 days for a maximum of 6 cycles.


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival followed by Overall Survival [ Time Frame: assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months/until progression, then every 12 weeks until then death ]

Secondary Outcome Measures :
  1. Quality of Life, as assessed by EORTC QLQ-C30 and EQ-5D questionnaires [ Time Frame: assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months, then every 12 weeks until death ]
  2. Safety and Tolerability as evaluated using CTCAE v 4.0 [ Time Frame: 22 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01168791


Locations
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Sponsors and Collaborators
Ziopharm
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ziopharm
ClinicalTrials.gov Identifier: NCT01168791    
Other Study ID Numbers: IPM3001
First Posted: July 23, 2010    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: July 2013
Keywords provided by Ziopharm:
Metastatic
Front line
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Liposomal doxorubicin
Isophosphamide mustard
Ifosfamide
 Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents