Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00005046
First received: April 6, 2000
Last updated: May 24, 2013
Last verified: July 2008
  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
Primary Peritoneal Cavity Cancer
Drug: chemotherapy
Drug: paclitaxel
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Study Start Date: April 2000
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005046

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
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Deborah K. Armstrong, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00005046     History of Changes
Other Study ID Numbers: CDR0000067638, GOG-9904, GP-700-9901
Study First Received: April 6, 2000
Last Updated: May 24, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
recurrent ovarian epithelial cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014