Pazopanib, Lapatinib or Trastuzumab in Subjects With Solid Tumors
The goal of this clinical research study is to find the highest tolerable dose of the combinations of pazopanib and either lapatinib or trastuzumab that can be given to patients with advanced cancer. The safety of the drug combinations will also be studied.
Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for tumor growth. This may prevent or slow the growth of cancer cells.
Lapatinib is designed to prevent or slow down the growth of cancer cells by blocking 2 proteins on the surface of the cancer cell, which are HER 1 and HER 2 receptors.
Trastuzumab is designed to prevent or slow down the growth of cancer cells by blocking proteins inside the cancer cell, called the Her2/neu receptor.
Drug: Trastuzumab (Herceptin®)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Pazopanib in Combination With Lapatinib or Trastuzumab in Subjects With Solid Tumors|
- Maximum Tolerated Dose (MTD) of Pazopanib in Combination with Lapatinib or Trastuzumab [ Time Frame: 28 day cycle ] [ Designated as safety issue: Yes ]MTD is defined as highest dose in which incidence of dose limiting toxicity (DLT) was less than 33% (approximately two or more participants in a dose cohort).
- Tumor Response [ Time Frame: End of second 28 day cycle ] [ Designated as safety issue: No ]Computed tomography (CT) scan, magnetic resonance imaging (MRI) scan, positron emission tomography (PET) scan, and/or x-ray to check the status of the disease. Tumor response calculated by Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization Working Group (WHO) criteria. A tumor response is defined as one or more of the following: (1) stable disease for more than or equal to 4 months, (2) decrease in measurable tumor (sentinel lesions) by more than or equal to 20% by RECIST criteria, (3) decrease in tumor markers by more than or equal to 25% or (4) a partial response according to the Choi criteria.
|Study Start Date:||October 2011|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm A: Pazopanib + Lapatinib
Oral Pazopanib 200 mg every other day starting on day 1 and oral Lapatinib 500 mg daily starting day 1, both for 28 days.
Starting dose: 200 mg by mouth every other day starting on day 1 for 28 days.
Other Name: GW78634Drug: Lapatinib
Starting dose 500 mg by mouth every day for 28 days.
Experimental: Arm B: Pazopanib + Trastuzumab
Oral Pazopanib 200 mg daily for 28 day cycle and Trastuzumab (Herceptin®) 4 mg/kg loading dose as a 90 minute infusion by vein on day 1 of cycle 1, with a maintenance dose of 2 mg/kg every week as 30 minute infusion by vein.
Drug: Trastuzumab (Herceptin®)
4 mg/kg loading dose as a 90 minute infusion by vein on day 1 of cycle 1.
Maintenance dose of 2 mg/kg every week as 30 minute infusion by vein.
Dose Expansion Phase: Maximum tolerated dose (MTD) from Dose Escalation Phase
Other Name: HerceptinDrug: Pazopanib
Starting dose 200 mg by mouth every day for 28 days.
Other Name: GW78634
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454804
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||David S. Hong, MD||M.D. Anderson Cancer Center|