Epithelial Ovarian Cancer Clinical Trial
Official title:
Phase II Study of Sequential Therapy With Paclitaxel Plus Carboplatin Followed by Gemzar Plus Carboplatin in the Treatment of Patients With Epithelial Ovarian Cancer FIGO Stages III-IV
| Verified date | June 2007 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Slovakia: State Institute for Drug Control |
| Study type | Interventional |
The purpose of this study is to evaluate the efficacy of paclitaxel and carboplatin followed by gemcitabine and carboplatin therapy for patients with epithelial ovarian cancer.
| Status | Completed |
| Enrollment | 7 |
| Est. completion date | April 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Histologically verified epithelial ovarian cancer - FIGO stage III-IV - Patients with measurable disease. RECIST criteria with GCIG modifications will be used for response and for progression assessment. - Lesions serving as measurable disease must have the longest diameter of greater than or equal to 20 mm as measured with conventional techniques or greater than or equal to 10 mm with spiral CT scan. Lesions measured by physical examination must have a longest diameter of greater than or equal to 20 mm. Exclusion Criteria: - Ovarian tumors with low malignant potential (borderline tumors) - Non-epithelial ovarian or mixed epithelial. non epithelial tumors (e.g. mixed Mullerian tumors) - Time between definitive surgery and enrollment into the study is greater than 6 weeks - Patients who have received previous chemotherapy or radiotherapy |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Slovakia | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bratislava |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
Slovakia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall response rate | |||
| Secondary | Progression-free survival | |||
| Secondary | 2-year survival | |||
| Secondary | Toxicity | |||
| Secondary | Dose intensity |
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