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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Malignancy, Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer, Testicular Cancer, Thymoma, Ovarian Cancer, Osteosarcoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the safety profile

Outcome Description:

Adverse events, vital signs, physical examination, laboratory data and concomitant medications

Outcome Time Frame:

21 Days

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

IPM1004

NCT ID:

NCT01242072

Start Date:

November 2010

Completion Date:

December 2012

Related Keywords:

  • Malignancy
  • Cancer
  • Non Small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Testicular Cancer
  • Thymoma
  • Ovarian Cancer
  • Osteosarcoma
  • malignancy
  • etoposide and carboplatin
  • non small cell lung cancer
  • small cell lung cancer
  • testicular cancer
  • thymoma
  • ovarian cancer
  • osteosarcoma
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Osteosarcoma
  • Ovarian Neoplasms
  • Testicular Neoplasms
  • Thymoma
  • Small Cell Lung Carcinoma

Name

Location

Washington UniversitySt. Louis, Missouri  63110
Medical Consultants, PCMuncie, Indiana  47304
Indiana University Simon Cancer CenterIndianapolis, Indiana  46202
Horizon Oncology ResearchLafayette, Indiana  47905