Sorafenib + Topotecan for Platinum-Resistant Recurrent Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title: A Phase I/II Study of Sorafenib in Combination With Topotecan for the Treatment of Platinum-Resistant Recurrent Ovarian Cancer or Primary Peritoneal Carcinomatosis: Hoosier Oncology Group GYN06-111

Status Terminated

Clinical Trial Summary

This multi-institutional phase I/II clinical trial will test the tolerability and efficacy of the combination sorafenib and topotecan in patients with recurrent ovarian cancer, which is platinum-resistant (recurrence within 6 months from completing platinum based therapy) or refractory (progressive disease during platinum based therapy).

Clinical Trial Description

OUTLINE: This is a multi-center study.

• Topotecan: 4mg/m2 weekly, 3 weeks on and one week off.

• Sorafenib: Assigned cohort dose for phase I (up to 12 patients) Maximum tolerated dose for phase II (21 total patients)

Cycles will consist of 4 weeks (28 days) with disease evaluations every 8 weeks.

Non-PD and acceptable toxicity: Patients will continue protocol therapy PD or unacceptable toxicity: Patients will discontinue protocol therapy

ECOG performance status 0-1

Life expectancy: Three (3) months

Hematopoietic:

• White blood cell count (WBC) > 3 K/mm3

• Hemoglobin (Hgb) > 9 g/dL

• Platelets > 100 K/mm3

• Absolute neutrophil count (ANC) > 1.5 K/mm3

• INR < 1.5 or a PTT within normal limits. NOTE: Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate.

• No evidence or history of bleeding diathesis or coagulopathy.

Hepatic:

• Bilirubin < 1.5 x ULN

• Aspartate aminotransferase (AST, SGOT) < 2.5 x ULN

• Alanine aminotransferase (ALT, SGPT) < 2.5 x ULN

• Alkaline phosphate < 2.5 x ULN

Renal:

• Creatinine < 1.5 x ULN

Cardiovascular:

• No history of myocardial infarction or angina pectoris or angina equivalent within 6 months prior to registration for protocol therapy (the patient may not be on anti-anginal or anti-arrhythmic medications), or have uncontrolled hypertension or congestive heart failure > class II NYHA

Pulmonary:

• No thrombolic or embolic events such as a cerebrovascular accident, including transient ischemic attacks within the past 6 months.

• No pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 28 days prior to registration for protocol therapy.

• No non-pulmonary hemorrhage/bleeding event > CTCAE Grade 3 within 28 days prior to registration for protocol therapy. ;

Study Design

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

• NCT number: NCT00526799
• Study type: Interventional
• Source: Hoosier Cancer Research Network
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: September 2007
• Completion date: August 2010