NCT00191607

Brief Summary

This trial compares two chemotherapy agents for the treatment of recurrent ovarian, fallopian or primary peritoneal cancer in patients that have received and are no longer responding to Platinum based treatment. The purpose of this trial is to compare progression free survival between gemcitabine and liposomal doxorubicin. Progression free survival (PFS) is defined as the period from study entry until disease progression

Trial Health

87
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2002

Typical duration for phase_3

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

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

January 26, 2007

Status Verified

January 1, 2007

First QC Date

September 12, 2005

Last Update Submit

January 24, 2007

Conditions

Genital Neoplasms, FemaleFallopian Tube NeoplasmsOvarian NeoplasmsPelvic NeoplasmsPeritoneal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • - Progression free survival (PFS) in patients who have failed one, but no more than two, prior treatments

Secondary Outcomes (6)

  • Secondary objectives:

  • Response rate

  • Duration of response

  • Time to treatment failure

  • Survival

  • +1 more secondary outcomes

Interventions

GemcitabineDRUG
liposomal doxorubicinDRUG

Eligibility Criteria

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

You may qualify if:

  • All patients must have a documented pathologic diagnosis of epithelial ovarian (FIGO Stage I-IV), Fallopian tube or primary peritoneal carcinoma
  • Patients must have received platinum-based, first-line chemotherapy but no more than one additional prior chemotherapy regimen. Patients must have recovered from the acute side effects of prior chemotherapy prior to enrollment in this trial.
  • Patients must be considered to have platinum resistant disease based on the most recent platinum-based regimen given, i.e., have had a treatment-free interval in response to platinum of less than six months, or have progressed during platinum-based therapy
  • Presence of measurable disease or CA-125 \> or = to 100 on two separate occasions at least one week apart is required for this study
  • Patient must have a Zubrod Performance Status of 0, 1 or 2

You may not qualify if:

  • Patients with a current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas) are not eligible. Patients with a prior diagnosis of a low malignant potential tumor that was surgically resected and who have subsequently developed invasive adenocarcinoma are eligible.
  • Patients who are currently undergoing abdominal or pelvic radiation therapy or patients who have received prior abdominal or pelvic radiation therapy are excluded.
  • Patients with unstable angina or who have had a heart attack within the past six months are not eligible to participate.
  • Patients who have received prior Gemzar or Doxil therapy are ineligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.

    PMID: 37407274DERIVED

MeSH Terms

Conditions

Genital Neoplasms, FemaleFallopian Tube NeoplasmsOvarian NeoplasmsPelvic NeoplasmsPeritoneal Neoplasms

Interventions

Gemcitabineliposomal doxorubicin

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesFallopian Tube DiseasesAdnexal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersAbdominal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesPeritoneal Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • CALL 1-877-CTLILLY (1-877-285-4559) OR 1-317-615-4559 MON-FRI 9AM-5PM Eastern Time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

July 1, 2002

Study Completion

November 1, 2005

Last Updated

January 26, 2007

Record last verified: 2007-01

Locations

US(1)