Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Ziopharm.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Ziopharm Identifier:
First received: November 12, 2010
Last updated: July 17, 2012
Last verified: July 2012
This an an open-label study to define the safety profile and the maximum tolerated dose and confirm the clinical effective dose of palifosfamide-tris given intravenously in combination with etoposide and carboplatin in a wide range of cancers which etoposide and carboplatin are normally given. Once the maximum dose of palifosfamide-tris is determined,a Phase II study using the 3 agents combined will begin.

Condition Intervention Phase
Non Small Cell Lung Cancer
Small Cell Lung Cancer
Testicular Cancer
Ovarian Cancer
Drug: palifosfamide-tris
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Intravenous (IV) Palifosfamide-tris Administered in Combination With IV Etoposide and IV Carboplatin in Patients With Malignancies for Which Etoposide and Carboplatin Are an Appropriate Choice

Resource links provided by NLM:

Further study details as provided by Ziopharm:

Primary Outcome Measures:
  • Assess the safety profile [ Time Frame: 21 Days ] [ Designated as safety issue: Yes ]
    Adverse events, vital signs, physical examination, laboratory data and concomitant medications

Secondary Outcome Measures:
  • Determine the maximum tolerated dose [ Time Frame: Up to 21 days ] [ Designated as safety issue: Yes ]
    Each dose level cohort will be 3 subjects. After 3 subjects have received a regimen, there will be a minimum observation period of 1 full cycle (21 days) for each of the 3 subjects before enrollment of the group of subjects at the next dose level.

  • Assess early signs of efficacy [ Time Frame: duration of study ] [ Designated as safety issue: No ]
    To assess early signs of efficacy using this investigational combination in this patient population

Estimated Enrollment: 12
Study Start Date: November 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PaCE
Palifosfamide, Carboplatin and Etoposide
Drug: palifosfamide-tris
Intravenous on days 1, 2 and 3 of each 21-day cycle for up to 4 cycles


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years old or greater
  • Malignancy scheduled to receive etoposide and carboplatin therapy
  • Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1
  • Adequate bone marrow, liver, renal function and coagulation status
  • Informed consent
  • Agree to use birth control through 28 days of last treatment dose
  • Pregnancy test for women of child-bearing potential
  • No available standard therapy

Exclusion Criteria:

  • Allergy to the the study treatment drugs
  • Unstable current medical condition
  • Presence or history of injury to the urinary tract
  • Active infection
  • Major surgery within 4 weeks prior to treatment
  • Minor surgery within 2 weeks prior to treatment
  • Current acute steroid therapy or taper
  • Currently pregnant or nursing
  • Substance abuse or condition that may interfere with participation
  • Received other investigational drugs within 30 days
  • Within 4 weeks of their last chemotherapy
  Contacts and Locations
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Please refer to this study by its identifier: NCT01242072

United States, Indiana
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Horizon Oncology Research
Lafayette, Indiana, United States, 47905
Medical Consultants, PC
Muncie, Indiana, United States, 47303
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
  More Information

Responsible Party: Ziopharm Identifier: NCT01242072     History of Changes
Other Study ID Numbers: IPM1004 
Study First Received: November 12, 2010
Last Updated: July 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ziopharm:
etoposide and carboplatin
non small cell lung cancer
small cell lung cancer
testicular cancer
ovarian cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Ovarian Neoplasms
Small Cell Lung Carcinoma
Testicular Neoplasms
Adnexal Diseases
Bronchial Neoplasms
Carcinoma, Bronchogenic
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Diseases, Male
Genital Neoplasms, Female
Genital Neoplasms, Male
Gonadal Disorders
Lung Diseases
Lymphatic Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Bone Tissue
Neoplasms, Complex and Mixed
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Ovarian Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Sarcoma processed this record on May 30, 2016