Back to resultsPaclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer
Primary Purpose
Ovarian Cancer, Primary Peritoneal Cavity Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
chemotherapy
paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent ovarian epithelial cancer, primary peritoneal cavity cancer
Eligibility 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
Sites / Locations
- Chao Family Comprehensive Cancer Center
- University of Chicago Cancer Research Center
- Indiana University Cancer Center
- Washington University School of Medicine
- Cleveland Clinic Taussig Cancer Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005046
First Posted
April 6, 2000
Last Updated
May 24, 2013
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00005046
Brief Title
Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer
Official Title
A Phase I Open Label Assessment of the Safety and Pharmacokinetics of Intraperitoneal PACLIMER Microspheres (Polilactofate/Paclitaxel) in Patients With Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of paclitaxel in treating patients who have recurrent or persistent ovarian or primary peritoneal cancer.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
recurrent ovarian epithelial cancer, primary peritoneal cavity cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
chemotherapy
Intervention Type
Drug
Intervention Name(s)
paclitaxel
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah K. Armstrong, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16626792
Citation
Armstrong DK, Fleming GF, Markman M, Bailey HH. A phase I trial of intraperitoneal sustained-release paclitaxel microspheres (Paclimer) in recurrent ovarian cancer: a Gynecologic Oncology Group study. Gynecol Oncol. 2006 Nov;103(2):391-6. doi: 10.1016/j.ygyno.2006.02.029. Epub 2006 Apr 19.
Results Reference
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Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer
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