A Phase I Open Label Assessment of the Safety and Pharmacokinetics of Intraperitoneal PACLIMER Microspheres (Polilactofate/Paclitaxel) in Patients With Ovarian Cancer
21 Years
N/A
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer
Trial Information
A Phase I Open Label Assessment of the Safety and Pharmacokinetics of Intraperitoneal PACLIMER Microspheres (Polilactofate/Paclitaxel) in Patients With Ovarian Cancer
OBJECTIVES: I. Determine the safety and tolerability of intraperitoneal administration of
paclitaxel (Paclimer microspheres) in patients with recurrent or persistent ovarian or
primary peritoneal carcinoma. II. Determine and confirm the maximum tolerated dose of this
regimen in this patient population. III. Determine plasma paclitaxel concentrations at
selected times after intraperitoneal administration of Paclimer microspheres in these
patients.
OUTLINE: This is a dose escalation study. Patients receive intraperitoneal paclitaxel
(Paclimer microspheres) every 8 weeks for 2 courses. Cohorts of 1-3 patients receive
escalating doses of intraperitoneal paclitaxel (Paclimer microspheres) until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 3 patients experience dose limiting toxicities. Once the probable MTD is determined, an
additional cohort of 8 patients is accrued to confirm the MTD. The MTD is confirmed as the
dose level at which at least 6 of 8 patients demonstrate acceptable safety and tolerability.
PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Recurrent or persistent ovarian and/or primary peritoneal
carcinoma Adequate potential intraperitoneal fluid distribution with no gross fluid
loculations and adhesions that would significantly affect intraperitoneal drug
distribution
PATIENT CHARACTERISTICS: Age: 21 and over Performance status: GOG 0-2 Life expectancy: At
least 6 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 WBC at least
3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3
Hepatic: Bilirubin no greater than 1.5 times upper limit of normal Renal: Creatinine less
than 2.0 mg/dL Other: No other sufficiently severe medical problems unrelated to
malignancy that would preclude study compliance or cause exposure to undue risks No prior
unmanageable reaction to paclitaxel
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior myelosuppressive chemotherapy (6 weeks for nitrosourea and mitomycin) and
recovered Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior
radiotherapy to major bone marrow containing areas Surgery: Not specified Other: At least
1 month since other prior investigational agents
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Deborah K. Armstrong, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000067638
NCT ID:
NCT00005046
Start Date:
April 2000
Completion Date:
Related Keywords:
- Ovarian Cancer
- Primary Peritoneal Cavity Cancer
- recurrent ovarian epithelial cancer
- primary peritoneal cavity cancer
- Ovarian Neoplasms
- Peritoneal Neoplasms
Name | Location |
|---|---|
| Chao Family Comprehensive Cancer Center | Orange, California 92868 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
