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Phase I Study of Rubitecan (RFS 2000) in the Treatment of Cancer Patients With Organ Dysfunction

Phase 1
18 Years
Not Enrolling

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Trial Information

Phase I Study of Rubitecan (RFS 2000) in the Treatment of Cancer Patients With Organ Dysfunction

Inclusion Criteria:

- The patient is at least 18 years of age.

- The patient has histologically or cytologically proven malignancy recurrent or
refractory to standard treatment or for which there is no standard therapy.

- The patient has measurable disease.

- The patient has sufficiently recovered from the acute toxic effects of previous
chemotherapy, radiotherapy (no less than 3 weeks prior to randomization), and/or

- The patient's estimated life expectancy is at least 8 weeks.

- The patient has a National Cancer Institute Common Toxicity Criteria (NCI CTC)
Performance Status between 0 and 2.

- The patient has adequate bone marrow function.

- The patient must not have active central nervous system (CNS) metastases.

Exclusion Criteria:

- The patient has any serious, uncontrolled intercurrent illness or infection.

- The patient is receiving anti-retroviral therapy (HAART) for HIV infection.

- The patient is pregnant or nursing.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:

RFS 2000-40



Start Date:

August 2001

Completion Date:

Related Keywords:

  • Tumors
  • rubitecan
  • Orathecin
  • 9-nitrocamptothecin
  • solid tumors
  • organ dysfunction
  • renal dysfunction
  • hepatic dysfunction
  • RFS 2000



Washington University School of Medicine Saint Louis, Missouri  63110
The Center for Cancer Care and Research St. Louis, Missouri  63141