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
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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:
Further study details as provided by Eli Lilly and Company:
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders 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
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:
No publications provided
| 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 |
| Health Authority: | Slovakia: State Institute for Drug Control |
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 Gemcitabine Carboplatin |
Paclitaxel Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Tubulin Modulators |
ClinicalTrials.gov processed this record on May 19, 2013