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A Phase I Open Label Assessment of the Safety and Pharmacokinetics of Intraperitoneal PACLIMER Microspheres (Polilactofate/Paclitaxel) in Patients With Ovarian Cancer

Phase 1
21 Years
Not Enrolling
Ovarian Cancer, Primary Peritoneal Cavity Cancer

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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

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

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:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Deborah K. Armstrong, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Federal Government

Study ID:




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



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