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Gemcitabine/Capecitabine/ZD6474 in Advanced Solid Tumors

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT00551096
Collaborator
AstraZeneca (Industry)
23
Enrollment
1
Location
1
Arm
67
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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.
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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.

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 Names:
  • Gemzar

    • Drug: Capecitabine
    Capecitabine administered orally at 1660 mg/m2/day divided into two doses for 21 days followed by a week-off.
    Other Names:
  • Xeloda

    • Drug: ZD6474
    Administered orally at 300 mg/day once daily. One cycle will consist of 28 days
    Other Names:
  • Zactima

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Tolerated Dose (MTD) of ZACTIMA (ZD6474) in combination with Gemcitabine and Capecitabine [Up to 28 days]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Denver Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver
    • AstraZeneca

    Investigators

    • Principal Investigator: Stephen Leong, MD, University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT00551096
    Other Study ID Numbers:
    • 07-0129.cc
    First Posted:
    Oct 30, 2007
    Last Update Posted:
    Dec 25, 2013
    Last Verified:
    Dec 1, 2013
    Keywords provided by University of Colorado, Denver
    Advanced Solid Tumors
    Biliary or Pancreatic Malignancies
    Additional relevant MeSH terms:
    Gemcitabine
    Capecitabine

    Study Results

    No Results Posted as of Dec 25, 2013