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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.


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Malignant Solid Tumour, Biliary Cancer, Pancreatic Cancer

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Trial Information

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.


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.


Inclusion Criteria:



- Age 18 years or older

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (measure of your
ability to perform everyday tasks)

- Life expectancy of at least three months

Blood samples and other testing may apply for further testing of eligibility.

Exclusion Criteria:

- Uncontrolled illness (for example, current infections or heart conditions)

- Abnormal laboratory tests (such as blood or urine testing)

- Pregnant or breastfeeding women

Further exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) of ZACTIMA (ZD6474) in combination with Gemcitabine and Capecitabine

Outcome Description:

To evaluate the safety profile and determine the MTD dose of ZACTIMA in combination with Gemcitabine and Capecitabine in patients with advanced malignancies. Toxicity will be graded per Common Toxicity Criteria for Adverse Effects (CTCAE) Version 3.0 and adverse event reporting for this study will be performed via Adverse Event Expedited Reporting System (AdEERS). All patients who receive any amount of the study drug will be evaluable for toxicity.

Outcome Time Frame:

Up to 28 days

Safety Issue:

Yes

Principal Investigator

Stephen Leong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Food and Drug Administration

Study ID:

07-0129.cc

NCT ID:

NCT00551096

Start Date:

October 2007

Completion Date:

October 2015

Related Keywords:

  • Malignant Solid Tumour
  • Biliary Cancer
  • Pancreatic Cancer
  • Advanced Solid Tumors
  • Biliary or Pancreatic Malignancies
  • Pancreatic Neoplasms
  • Neoplasms
  • Biliary Tract Neoplasms

Name

Location
University of Colorado Denver Denver, Colorado  80262