Gemcitabine/Capecitabine/ZD6474 in Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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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

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Malignant Solid Tumour Biliary Cancer Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Gemcitabine

Intervention Type DRUG

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

Capecitabine

Intervention Type DRUG

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

ZD6474

Intervention Type DRUG

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

Interventions

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Gemcitabine

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

Intervention Type DRUG

Capecitabine

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

Intervention Type DRUG

ZD6474

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

Intervention Type DRUG

Other Intervention Names

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Gemzar Xeloda Zactima

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No