Treatment of Paclitaxel Plus Carboplatin Followed by Gemcitabine Plus Carboplatin for Patients With Epithelial Ovarian Cancer
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ClinicalTrials.gov Identifier: NCT00490711 |
Recruitment Status
:
Completed
First Posted
: June 25, 2007
Last Update Posted
: June 25, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Epithelial Ovarian Cancer | Drug: gemcitabine Drug: carboplatin Drug: paclitaxel | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
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 |
Study Start Date : | July 2003 |
Actual Study Completion Date : | April 2005 |

- Overall response rate
- Progression-free survival
- 2-year survival
- Toxicity
- Dose intensity

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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): NCT00490711
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 |
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 |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00490711 History of Changes |
Other Study ID Numbers: |
4720 B9E-MC-S205 |
First Posted: | June 25, 2007 Key Record Dates |
Last Update Posted: | June 25, 2007 |
Last Verified: | June 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 |