Lapatinib and Cetuximab in Patients With Solid Tumors

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT01184482
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • cetuximab and lapatinib — DRUG
    Cetuximab: 400 mg/m2 on Day 1 then 250 mg/m2 weekly Lapatinib: Start once daily on Day 1. Dose escalating cohorts: 1. 750 mg (3 tabs) 2. 1000 mg (4 tabs) 3. 1250 mg (5 tabs)

Study Details

This trial is for patients with colon cancer, head and neck cancer and lung cancer that has not responded to standard therapy. Cetuximab targets a receptor on cancer cells called the Epidermal Growth Factor Receptor or EGFR. It is thought that this receptor is turned "on" in some cancers, enabling cancer cells to divide and grow. Blocking this receptor can turn this signal off. Cetuximab blocks this receptor from the outside of cancer cells. It is thought that cancer cells can turn this signal back on by the EGFR joining with a related receptor called ErbB2. Lapatinib blocks both EGFR and ErbB2 from the inside of cancer cells. In laboratory experiments it has been found that combining drugs that target both EGFR and ErbB2 might work better in turning this signal back off. The purpose of this study is to determine the maximum dosages that patients can tolerate when these two medicines are given at the same time. In addition, in order to be on this trial, patients must agree to have a tumor biopsy before starting treatment on this study and 21 days after starting treatment. These biopsies are a required part of the study. Patients must also agree to have blood drawn for research testing to see whether genetic differences between patients explain different reactions to and side effects from, these medicines.

Key Dates

Start date
Jun 30, 2010
Status verified
Oct 2013
Primary completion
Jun 30, 2013
Completion
Sep 30, 2013

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cetuximab and lapatinib
    All patients will receive cetuximab by IB weekly and daily doses of lapatinib orally in 3 week cycles with response assessed every 2 cycles.

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Georgetown University Medical CenterWashington D.C.District of Columbia20007-

Find similar trials in Washington D.C., DC

By condition
Colorectal cancerHead and neck cancerLung cancer
By specialty
OncologyGI oncologyENTLung oncologyLung disease
By research site
Georgetown University Medical Center· Washington D.C., DC

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