Trial Information

Summary: A Phase II Randomized Trial of BAY 43-9006, a Novel Raf Kinase Inhibitor, versus BAY 43-9006 plus Paclitaxel/Carboplatin in Women with Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer (CASE 2804)

To conduct two parallel phase II trials:

• single agent BAY 43-9006
• BAY 43-9006 plus carboplatin and paclitaxel

To compare the progression-free survival rate of single agent BAY 43-9006 to that of the combination of BAY 43-9006 plus carboplatin and paclitaxel.

Patient Inclusion Criteria:

• Patients with recurrent epithelial ovarian cancer, primary peritoneal or fallopian tube cancer that is considered platinum sensitive (a treatment free interval greater than 6 months) will be eligible for this trial.
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
• Patients must have received prior therapy with a platinum-based regimen before study enrollment but patients must not have had more than 2 chemotherapy regimens, and must be platinum sensitive (a treatment interval of greater than 6 months). Prior hormonal therapy is allowed.
• Age >18 years. Because no dosing or adverse event data are currently available on the use of BAY 43-9006 in combination with paclitaxel and carboplatin in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric phase 2 combination trials.
• Life expectancy of greater than 12 weeks.
• ECOG performance status 0-2 (Karnofsky >80%).
• Patients must have normal organ and marrow function as defined below:
• hemoglobin >9 gm/dL
• absolute neutrophil count >1,500/L
• platelets >100,000/L
• total bilirubin < 1.5 X upper limit of normal
• AST(SGOT)/ALT(SGPT) <2 X institutional upper limit of normal
• creatinine < 2.0 mg/dL
• The effects of BAY 43-9006 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because raf kinase inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Patients must have adequate intestinal function i.e. does not require IV hydration or nutritional support.
• Ability to understand and the willingness to sign a written informed consent document.

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Trial listings updated: June 1, 2008 at 6:42:54 AM