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Treatment of Paclitaxel Plus Carboplatin Followed by Gemcitabine Plus Carboplatin for Patients With Epithelial Ovarian Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00490711
First Posted: June 25, 2007
Last Update Posted: June 25, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
  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:


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

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


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
First Submitted: June 21, 2007
First Posted: June 25, 2007
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