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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


Phase 2
18 Years
75 Years
Not Enrolling
Female
Epithelial Ovarian Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Slovakia: State Institute for Drug Control

Study ID:

4720

NCT ID:

NCT00490711

Start Date:

July 2003

Completion Date:

April 2005

Related Keywords:

  • Epithelial Ovarian Cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

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