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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191607
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007

September 12, 2005
January 24, 2007
July 2002
Not Provided
- Progression free survival (PFS) in patients who have failed one, but no more than two, prior treatments
Same as current
Complete list of historical versions of study NCT00191607 on ClinicalTrials.gov Archive Site
  • Secondary objectives:
  • Response rate
  • Duration of response
  • Time to treatment failure
  • Survival
  • Quality of life
  • Secondary objectives:
  • - Response rate
  • - Duration of response
  • - Time to treatment failure
  • - Survival
  • - Quality of life
Not Provided
Not Provided
 
A Randomized Trial for Patients With Platinum Resistant Ovarian, Fallopian or Primary Peritoneal Cancer.
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Genital Neoplasms, Female
  • Fallopian Tube Neoplasms
  • Ovarian Neoplasms
  • Pelvic Neoplasms
  • Peritoneal Neoplasms
  • Drug: Gemcitabine
  • Drug: liposomal doxorubicin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
November 2005
Not Provided

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00191607
6890, B9E-US-S301
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
Study Director: 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
Eli Lilly and Company
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP