Treatment of Paclitaxel Plus Carboplatin Followed by Gemcitabine Plus Carboplatin for Patients With Epithelial Ovarian Cancer - Full Text View

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:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Paclitaxel Carboplatin Gemcitabine Gemcitabine hydrochloride

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Ovarian Epithelial Cancer

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Overall response rate

Secondary Outcome Measures:

Progression-free survival
2-year survival
Toxicity
Dose intensity


Enrollment:	7
Study Start Date:	July 2003
Study Completion Date:	April 2005

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

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

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:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

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:


Neoplasms, Glandular and Epithelial Ovarian Neoplasms Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms	Neoplasms by Histologic Type Neoplasms by Site Ovarian Diseases Urogenital Neoplasms Carboplatin Antineoplastic Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015