A Randomized Trial for Patients With Platinum Resistant Ovarian, Fallopian or Primary Peritoneal Cancer.
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| ClinicalTrials.gov Identifier: NCT00191607 |
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Recruitment Status :
Completed
First Posted : September 19, 2005
Last Update Posted : January 26, 2007
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Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
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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 Type : | Interventional (Clinical Trial) |
| Enrollment : | 162 participants |
| 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 : | July 2002 |
| Study Completion Date : | November 2005 |
Resource links provided by the National Library of Medicine
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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| ClinicalTrials.gov Identifier: | NCT00191607 |
| Other Study ID Numbers: |
6890 B9E-US-S301 |
| First Posted: | September 19, 2005 Key Record Dates |
| Last Update Posted: | January 26, 2007 |
| Last Verified: | January 2007 |
Additional relevant MeSH terms:
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Neoplasms Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Genital Neoplasms, Female Pelvic Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Gemcitabine Doxorubicin Liposomal doxorubicin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |