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| ID | Type | Description | Link |
|---|---|---|---|
| B9E-US-S301 |
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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | |||
| liposomal doxorubicin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| - Progression free survival (PFS) in patients who have failed one, but no more than two, prior treatments |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary objectives: | ||
| Response rate | ||
| Duration of response |
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Inclusion Criteria:
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37407274 | Derived | Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3. |
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| Time to treatment failure |
| Survival |
| Quality of life |
| United States |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D010386 | Pelvic Neoplasms |
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D000008 | Abdominal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| C506643 | liposomal doxorubicin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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