CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Carboplatin +2 moredrug
Likely dose
Sorafenib 400 mg orally twice daily plus paclitaxel and carboplatin (IV doses not specified)AI-extracted
Key inclusion· 7
  • Diagnosis of ovarian epithelial, primary peritoneal, or fallopian tube cancer
  • Recurrent disease with prior platinum-based regimen
  • Platinum-sensitive (treatment-free interval >6 months)
  • No more than 2 prior chemotherapy regimens
Key exclusion· 8
  • Known brain metastases
  • Other invasive malignancy within past 5 years (except nonmelanoma skin cancer)
  • Symptomatic congestive heart failure
  • Uncontrolled hypertension, cardiac arrhythmia, unstable angina, or myocardial infarction within 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00096200
NCT00096200Phase 2Completed

A Phase II Trial Of BAY 43-9006, A Novel Raf Kinase Inhibitor Plus Paclitaxel/Carboplatin In Women With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Or Fallopian Tube Cancer

National Cancer Institute (NCI)·interventional·Posted Nov 9, 2004·Updated Feb 8, 2022

In Brief

A Phase 2 clinical trial evaluating Carboplatin, Paclitaxel, and 1 other intervention for Recurrent Fallopian Tube Carcinoma and 2 related conditions. Completed, enrolled 44 participants across 5 sites.

Detailed Summary

Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving sorafenib together with chemotherapy may kill more tumor cells. This randomized phase II trial is studying how well giving sorafenib together with paclitaxel and carboplatin works in treating patients with recurrent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. (Sorafenib only group closed as of 10/10/2008).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 9, 2004
Enrollment StartAug 1, 2004
Primary CompletionApr 21, 2011
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 21.6 years ago

Interventions

Carboplatindrug

Given IV

Paclitaxeldrug

Given IV

Sorafenib Tosylatedrug

Given orally