NCT00312650

Brief Summary

Standard treatment for recurrent ovarian cancer is chemotherapy with one or more drugs. One of these drugs, Doxil, can cause skin toxicity at the standard dosages. This study investigates using a lower dose given more frequently in combination with a second drug Gemcitabine.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

April 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 10, 2006

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

January 12, 2015

Status Verified

January 1, 2015

Enrollment Period

1 month

First QC Date

April 6, 2006

Last Update Submit

January 9, 2015

Conditions

Ovarian Carcinoma

Keywords

ovarian cancerrecurrentprogressive

Outcome Measures

Primary Outcomes (1)

  • rate of hand-foot syndrome

Secondary Outcomes (1)

  • objective response rate

Interventions

liposomal doxorubicin and gemcitabineDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • recurrent platinum resistant ovarian cancer
  • measurable disease

You may not qualify if:

  • prior treatment with Doxil or Gemzar
  • life expectancy \<3months
  • cardiac ejection fraction \<50%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women and Infants' Hospital

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsRecurrence

Interventions

liposomal doxorubicinGemcitabine

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Paul A DiSilvestro, MD

    Program in Women's Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 6, 2006

First Posted

April 10, 2006

Study Start

April 1, 2006

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

January 12, 2015

Record last verified: 2015-01

Locations

US(1)