Lapatinib + Paclitaxel for Ovarian Cancer

Overseen By Frederick Ueland, MD

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Frederick R. Ueland, M.D.

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers

Disqualifiers: Hypersensitivity, Uncontrolled illness, Malabsorption, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Frederick R. Ueland

Principal Investigator

Markey Cancer Center

Eligibility Criteria

This trial is for people with ovarian cancer that came back within a year after platinum-based chemo. They should be fairly active (ECOG ≤2), have good organ and bone marrow function, and able to consent. It's not for those allergic to the drugs being tested, with uncontrolled sickness, heart failure, trouble absorbing food, taking certain other meds or any experimental cancer treatments.

Inclusion Criteria

My organs and bone marrow are working well.

I can take care of myself and am up and about more than half of my waking hours.

My ovarian cancer returned within a year after platinum chemotherapy.

Exclusion Criteria

I am not allergic to lapatinib or paclitaxel.

I am taking medication that affects liver enzyme CYP3A4.

I have been diagnosed with congestive heart failure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dose-escalation of Lapatinib and Paclitaxel to establish the phase II dose

4 weeks

Visits on days 1, 8, and 15

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Lapatinib
• Paclitaxel

Trial Overview The study tests increasing doses of Lapatinib combined with Paclitaxel in patients whose ovarian cancer resisted platinum chemotherapy. The goal is to find the safest dose level that can be used in future phase II trials.

Participant Groups

Group I: Lapatinib - Group 4 Experimental Treatment 1 Intervention

Patients in this group will receive Lapatinib (2000mg PO BID) and Paclitaxel (80mg/m2).

Group II: Lapatinib - Group 3 Experimental Treatment 1 Intervention

Patients in this group will receive Lapatinib (1500mg PO BID) and Paclitaxel (80mg/m2).

Group III: Lapatinib - Group 2 Experimental Treatment 1 Intervention

Patients in this group will receive Lapatinib (750mg PO BID) and Paclitaxel (80mg/m2).

Group IV: Lapatinib - Group 1 Experimental Treatment 1 Intervention

Patients in this group will receive Lapatinib (500mg PO BID) and Paclitaxel (80mg/m2).

Lapatinib is already approved in United States, European Union for the following indications:

Approved in United States as Tykerb for:

• Advanced or metastatic breast cancer in combination with capecitabine for patients whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab

Approved in European Union as Tyverb for:

• Advanced or metastatic breast cancer in combination with capecitabine for patients whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab

Who Is Running the Clinical Trial?

Frederick R. Ueland, M.D.

Lead Sponsor

Trials

6

Recruited

850+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+