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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


Phase 3
18 Years
N/A
Not Enrolling
Female
Genital Neoplasms, Female, Fallopian Tube Neoplasms, Ovarian Neoplasms, Pelvic Neoplasms, Peritoneal Neoplasms

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

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

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

6890

NCT ID:

NCT00191607

Start Date:

July 2002

Completion Date:

November 2005

Related Keywords:

  • Genital Neoplasms, Female
  • Fallopian Tube Neoplasms
  • Ovarian Neoplasms
  • Pelvic Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms
  • Fallopian Tube Neoplasms
  • Genital Neoplasms, Female
  • Ovarian Neoplasms
  • Pelvic Neoplasms
  • Peritoneal Neoplasms

Name

Location

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