Dose Escalation of Lapatinib With Paclitaxel in Ovarian Cancer

• Status: Recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

This trial will be a phase I dose-escalation study of lapatinib and paclitaxel for platinum-resistant ovarian cancer, which will establish the phase II dose for subsequent efficacy trials.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Frederick R. Ueland, M.D.
• Treatments: Lapatinib; Paclitaxel

Criteria

Inclusion Criteria:

• histologically or cytologically confirmed ovarian cancer who recur within 12 months of platinum-based chemotherapy

• ECOG performance status less than or equal to 2

• Adequate organ and marrow function at baseline

• ability to sign a written informed consent document

Exclusion Criteria:

• hypersensitivity to lapatinib or paclitaxel

• uncontrolled intercurrent illness

• receiving medications that inhibit or induce CYP3A4

• malabsorption syndrome

• congestive heart failure

• receiving any other anti-cancer investigational agents

• baseline neuropathy greater than Grade 1