A Randomized Trial for Patients With Platinum Resistant Ovarian, Fallopian or Primary Peritoneal Cancer.
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Genital Neoplasms, Female Fallopian Tube Neoplasms Ovarian Neoplasms Pelvic Neoplasms Peritoneal Neoplasms |
Drug: Gemcitabine Drug: liposomal doxorubicin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: 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 |
Resource links provided by NLM:
Drug Information available for:
Doxorubicin
Doxorubicin hydrochloride
Gemcitabine
Gemcitabine hydrochloride
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
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
| Estimated Enrollment: | 162 |
| Study Start Date: | July 2002 |
| Estimated Study Completion Date: | November 2005 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191607
Locations
| United States, Missouri | |
| 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 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00191607 History of Changes |
| Other Study ID Numbers: | 6890, B9E-US-S301 |
| Study First Received: | September 12, 2005 |
| Last Updated: | January 24, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Fallopian Tube Neoplasms Genital Neoplasms, Female Ovarian Neoplasms Pelvic Neoplasms Peritoneal Neoplasms Urogenital Neoplasms Neoplasms by Site Fallopian Tube Diseases Adnexal Diseases Genital Diseases, Female Endocrine Gland Neoplasms Ovarian Diseases Endocrine System Diseases Gonadal Disorders |
Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Doxorubicin Gemcitabine Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 19, 2013