NCT00551096

Gemcitabine/Capecitabine/ZD6474 in Advanced Solid Tumors

A Phase I Study of Gemcitabine, Capecitabine and ZD6474 (ZACTIMA) in Patients With Advanced Solid Tumors With an Expanded Cohort of Patients With Biliary or Pancreatic Malignancies.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Zactima will be used in this study to determine the highest dose that can be given safely as well as the side effects of Zactima when in combination with two FDA approved drugs; gemcitabine and capecitabine. This combination will be given to patients with advanced solid tumors. Once the highest dose of the combination has been determined, additional patients with biliary cancers (cholangiocarcinomas and gallbladder cancer) and locally advanced or metastatic pancreatic cancer will be treated at the highest determined dose for further studies.

Detailed description

This phase I study will access a novel regimen using a multi-targeted anti-angiogenic agent which targets the tyrosine kinase of vascular endothelial growth factor (VEGF) receptor 2 and epidermal growth factor receptor (EGFR) in combination with cytotoxic agents: gemcitabine and capecitabine. The rationale is based on observations that there is an additive / synergistic effect when cytotoxic agents are combined with angiogenesis inhibitors. There is also evidence that EGFR mediated signaling pathways are potent stimulators of VEGF production. Also the concept of dual targeting of tumor and endothelial cells may provide more encouraging results.

Conditions

• Malignant Solid Tumour
• Biliary Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine administered intravenously over 30 minutes on days 1, 8 and 15 of each cycle at a fixed dose of 1000mg/m2.
DRUG	Capecitabine	Capecitabine administered orally at 1660 mg/m2/day divided into two doses for 21 days followed by a week-off.
DRUG	ZD6474	Administered orally at 300 mg/day once daily. One cycle will consist of 28 days

Timeline

• Start date: 2007-10-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2007-10-30
• Last updated: 2013-12-25

Locations

1 site across 1 country: United States