Gemcitabine/Capecitabine/ZD6474 in Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00551096
First received: October 26, 2007
Last updated: December 23, 2013
Last verified: December 2013

October 26, 2007
December 23, 2013
October 2007
May 2013   (final data collection date for primary outcome measure)
Maximum Tolerated Dose (MTD) of ZACTIMA (ZD6474) in combination with Gemcitabine and Capecitabine [ Time Frame: Up to 28 days ] [ Designated as safety issue: Yes ]
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.
Not Provided
Complete list of historical versions of study NCT00551096 on ClinicalTrials.gov Archive Site
Not Provided
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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.

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Malignant Solid Tumour
  • Biliary Cancer
  • Pancreatic Cancer
  • Drug: Gemcitabine
    Gemcitabine administered intravenously over 30 minutes on days 1, 8 and 15 of each cycle at a fixed dose of 1000mg/m2.
    Other Name: Gemzar
  • Drug: Capecitabine
    Capecitabine administered orally at 1660 mg/m2/day divided into two doses for 21 days followed by a week-off.
    Other Name: Xeloda
  • Drug: ZD6474
    Administered orally at 300 mg/day once daily. One cycle will consist of 28 days
    Other Name: Zactima
Experimental: Gemcitabine, capecitabine and ZD6474

Gemcitabine administered intravenously over 30 minutes on days 1, 8 and 15 of each cycle at a fixed dose of 1000mg/m2.

Capecitabine administered orally at 1660 mg/m2/day divided into two doses for 21 days followed by a week-off .

ZD6474 administered orally at 300 mg/day once daily. One cycle will consist of 28 days.

Interventions:
  • Drug: Gemcitabine
  • Drug: Capecitabine
  • Drug: ZD6474
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
May 2013
May 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00551096
07-0129.cc
Yes
University of Colorado, Denver
University of Colorado, Denver
AstraZeneca
Principal Investigator: Stephen Leong, MD University of Colorado, Denver
University of Colorado, Denver
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP