IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Treatment of Paclitaxel Plus Carboplatin Followed by Gemcitabine Plus Carboplatin for Patients With Epithelial Ovarian Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00490711
First received: June 21, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Epithelial Ovarian Cancer | Drug: gemcitabine Drug: carboplatin Drug: paclitaxel | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
ovarian cancer
MedlinePlus related topics:
Ovarian Cancer
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490711
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490711
Locations
| 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, Slovakia | |
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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00490711 History of Changes |
| Other Study ID Numbers: |
4720 B9E-MC-S205 |
| Study First Received: | June 21, 2007 |
| Last Updated: | June 21, 2007 |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms by Histologic Type Paclitaxel Gemcitabine |
Albumin-Bound Paclitaxel Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on August 18, 2017