NCT00021034

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 taurolidine in treating patients who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2001

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2001

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

February 16, 2004

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

5 months

First QC Date

July 11, 2001

Last Update Submit

June 17, 2013

Conditions

Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer

Keywords

stage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancerfallopian tube cancerprimary peritoneal cavity cancer

Interventions

chemotherapyDRUG
taurolidineDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal adenocarcinoma Stage IIC or higher at diagnosis Successfully received prior chemotherapy Undergone initial cytoreductive surgery Evidence of gross disease at second-look surgery PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST and/or ALT less than 3 times upper limit of normal No clinically significant PT/PTT abnormality Renal: Creatinine less than 1.7 mg/dL Other: No known hypersensitivity to taurolidine or its excipients No other clinically significant disease that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: At least 30 days since prior investigational drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

Drug Therapytaurolidine

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Paul Sabbatini, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2001

First Posted

February 16, 2004

Study Start

March 1, 2001

Primary Completion

August 1, 2001

Study Completion

August 1, 2001

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

US(1)