NCT01542047

A Combination of Pazopanib and Carboplatin in Advanced Solid Malignancies

A Phase I Combination of Pazopanib and Carboplatin in Advanced Solid Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: New Mexico Cancer Research Alliance · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to investigate the possibility that use of two similar but distinct drugs used together in treatment of advanced cancer might prove less toxic than either agent used alone, because dosages can be reduced for each agent. This is a phase I study that is designed to measure the frequency and levels of specific side effects when Carboplatin and Pazopanib are used in combination in advanced cancer patients. The possibility that anti-tumor activity will occur is also going to be investigated.

Detailed description

Pazopanib has shown a promising anti-cancer activity as a single agent tyrosine kinase inhibitor. Activity against multiple tumors such as renal cell carcinoma (RCC) and neuroendocrine tumors have been documented, and it recently gained FDA approval for the treatment of metastatic kidney cancer. Also, an impressive activity as a single agent was recently reported in non-small cell lung cancer (NSCLC) in the neoadjuvant setting, where tumor shrinkage occurred in 86% of patients. Encouraging activity has also been seen in cervical cancer, ovarian cancer and soft tissue sarcomas. Multi-kinase targeting is an approach that may prove beneficial in a number of patient populations. In particular cancers such as breast, colon, pancreas etc., patients represent heterogeneous population of small groups based on genetic analyses. Some of these populations may benefit when multiple agents are given which have similar, but distinct targets of action. Dosages and therefore associated toxicities might be reduced by such an approach.

Conditions

• Cancer, Metastatic

Interventions

Type	Name	Description
DRUG	Carboplatin	Carboplatin will be administered intravenously over approximately 30 minutes on day 1 of each cycle. The dosage used will be 5 AUC for the first 5 cycles, and will be increased to 6 AUC for the sixth cycle.
DRUG	Pazopanib	Pazopanib will be administered orally at 200 to 800 mg/kg2. It will be given either on days 1 through 21 of each 3-week cycle, or if needed, it will be given on days 3 through 19.

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-02-01
• Completion: 2013-07-01
• First posted: 2012-03-01
• Last updated: 2015-06-18

Locations

1 site across 1 country: United States