Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of karenitecin in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer that has not responded to platinum-based treatment.
Primary Peritoneal Cavity Cancer
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation Of Karenitecin (IND #57250) In The Third-Line Treatment Of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma|
|Study Start Date:||January 2003|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
- Determine the antitumor activity of karenitecin in patients with persistent or recurrent platinum-resistant ovarian epithelial or primary peritoneal cancer.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive karenitecin IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter .
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-22 months.
Show 59 Study Locations
|Study Chair:||John J. Kavanagh, MD||M.D. Anderson Cancer Center|
|Investigator:||Judith A. Smith, PharmD, BCOP||M.D. Anderson Cancer Center|