A Randomized Trial for Patients With Platinum Resistant Ovarian, Fallopian or Primary Peritoneal Cancer.

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00191607

Collaborator

(none)

162

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Genital Neoplasms, Female Fallopian Tube Neoplasms Ovarian Neoplasms Pelvic Neoplasms Peritoneal Neoplasms	Drug: Gemcitabine Drug: liposomal doxorubicin	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized Phase III Trial of Gemzar Versus Doxil With Crossover Treatment Option for Patients With Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer Undergoing Second or Third-Line Chemotherapy

Study Start Date :

Jul 1, 2002

Study Completion Date :

Nov 1, 2005

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Secondary objectives: []
Response rate []
Duration of response []
Time to treatment failure []
Survival []
Quality of life []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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	United States	63110