Lapatinib and Capecitabine for Second Line Treatment of Pancreas Cancer

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

Sponsor
Georgetown University
Study ID
NCT00881621
Phase
PHASE2
Status
Terminated

Conditions

  • Pancreas Cancer

Eligibility Criteria

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

Interventions

  • Lapatinib and Capecitabine — DRUG
    Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles

Study Details

Patients are being asked to participate in this study who have locally advanced or metastatic pancreatic cancer (cancer of the pancreas that has spread to another part of the body) that has gotten worse after first-line chemotherapy. The purpose of this study is to see if the drugs, Capecitabine and Lapatinib (two chemotherapy agents), prolong survival and improve quality of life as compared to supportive care alone. Lapatinib in combination with a drug called capecitabine, has been approved by the Food and Drug Administration (FDA) for the treatment of metastatic breast cancer. It has not yet been approved to treat this type of cancer. Both of these drugs are pills. This research is being done because it is not known if the combination of Capecitabine and Lapatinib is better than supportive care alone for pancreatic cancer.

Key Dates

Start date
Aug 31, 2009
Status verified
Jan 2017
Primary completion
Dec 31, 2012
Completion
Jun 30, 2013

Study Design

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

Arms

  • Experimental: Lapatinib and Capecitabine
    Treatment

Primary Outcome Measure

Overall Survival [ Time Frame: 24 months ]

Locations (1)

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

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