|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005046 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Peritoneal Cavity Cancer |
Drug: chemotherapy Drug: paclitaxel |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 Start Date: | April 2000 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Study Chair: | Deborah K. Armstrong, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000067638, GOG-9904, GP-700-9901 |
| Study First Received: | April 6, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005046 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent ovarian epithelial cancer peritoneal cavity cancer |
|
Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Therapeutic Uses Peritoneal Diseases Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Mitosis Modulators |
Genital Neoplasms, Female Endocrine System Diseases Antimitotic Agents Abdominal Neoplasms Pharmacologic Actions Adnexal Diseases Neoplasms Digestive System Diseases Paclitaxel Tubulin Modulators Peritoneal Neoplasms Antineoplastic Agents, Phytogenic |
